Empower 3 Functionality Document PDF

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Empower
Software Functionality
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Empower 3
Build 3471
April, 2011
Table of Contents
SECTION 1 - INTRODUCTION ................................................................................................................ 1
Basic Principles ......................................................................................................................................... 1
What Makes Empower 3 Unique? .......................................................................................................... 1
Multiple User Interfaces ......................................................................................................................... 2
Central Database.................................................................................................................................... 2
Features ............................................................................................................................................. 2
Benefits .............................................................................................................................................. 2
Security and Regulatory Compliance ..................................................................................................... 3
Features ............................................................................................................................................. 3
Benefits .............................................................................................................................................. 3
Component-Based Architecture .............................................................................................................. 4
Features ............................................................................................................................................. 4
Benefits .............................................................................................................................................. 4
Scalable Architecture ............................................................................................................................. 5
Features ............................................................................................................................................. 5
Benefits .............................................................................................................................................. 5
Empower 3 Designed for the Enterprise................................................................................................. 6
Empower Scalability Strategy ................................................................................................................ 7
Rapid Deployment .................................................................................................................................12
Enterprise Authentication Using Active Directory (LDAP) ..................................................................12
Citrix Environments...............................................................................................................................12
SECTION 2 - TECHNOLOGY ................................................................................................................... 1
Licenses and Key Disks ............................................................................................................................ 1
Named User Licenses ............................................................................................................................. 1
Base License ........................................................................................................................................... 2
Client/Server and Workstation Specific Licenses ................................................................................... 2
Options Not Requiring Licenses ............................................................................................................. 2
System Licenses ...................................................................................................................................... 2
The Waters Service................................................................................................................................... 3
Data Acquisition and Buffering ............................................................................................................... 3
How Oracle and Server Failures are Recognized .................................................................................. 4
Local Directory and File Organization .................................................................................................. 5
How Identifiers are Assigned ................................................................................................................. 5
Empower 3 and Date Handling ............................................................................................................... 5
How Empower 3 Handles Dates ............................................................................................................. 5
Oracle Date Format ............................................................................................................................... 5
Microsoft Date Format ........................................................................................................................... 6
Where Do The Dates Come From? ........................................................................................................ 6
Empower 3 Use of Oracle Tablespaces ................................................................................................... 7
Application Components .......................................................................................................................... 8
Empower 3 ‘Servers’ ...............................................................................................................................10
Instrument Server ..................................................................................................................................10
Processing Server ..................................................................................................................................10
SECTION 3 – FUNCTIONALITY ............................................................................................................. 1
Definitions ................................................................................................................................................. 1
Empower 3 General Description ............................................................................................................. 2
Configuration Manager ........................................................................................................................... 4
Projects ................................................................................................................................................... 5
Users ....................................................................................................................................................... 6
User Groups ........................................................................................................................................... 7
User Types .............................................................................................................................................. 7
Acquisition Servers ................................................................................................................................. 7
Systems ................................................................................................................................................... 8
Default Strings .......................................................................................................................................11
Privileges ...............................................................................................................................................11
System Policies ......................................................................................................................................17
Message Center ........................................................................................................................................19
System Monitor........................................................................................................................................20
Installation ...............................................................................................................................................21
Custom Fields ..........................................................................................................................................22
Login Dialog Box .....................................................................................................................................24
Raw Data Security ...................................................................................................................................24
Database Security ....................................................................................................................................24
Client/Server Network Support..............................................................................................................26
General ..................................................................................................................................................26
Audit Trails ..............................................................................................................................................27
General ..................................................................................................................................................27
System Audit Trails ................................................................................................................................27
Project Audit Trails ...............................................................................................................................27
System Policies .........................................................................................................................................28
User Account Policies ...........................................................................................................................28
New Project Policies .............................................................................................................................29
System Audit Trail Policies....................................................................................................................30
Other Policies ........................................................................................................................................31
Instrument Control .................................................................................................................................33
General Functionality ...........................................................................................................................33
Result Sign Off .........................................................................................................................................35
Pro Interface ..................................................................................................................................36
Pro Window .............................................................................................................................................36
Project Window .......................................................................................................................................37
Views .....................................................................................................................................................39
View Filters ...........................................................................................................................................40
Tools ......................................................................................................................................................41
Alter Sample ..........................................................................................................................................42
Compare ................................................................................................................................................43
Import / Export ......................................................................................................................................43
Run Samples ............................................................................................................................................44
Run Samples Toolbar ............................................................................................................................46
Sample Loading Table ...........................................................................................................................46
Processing .................................................................................................................................................48
Derived Channels.....................................................................................................................................51
Review Window .......................................................................................................................................51
Review Main Window Toolbar ..............................................................................................................55
Processing Method Window ..................................................................................................................57
Results Window .....................................................................................................................................60
Calibration Curve Window ....................................................................................................................60
Method Set Editor ..................................................................................................................................60
PDA/MS Functionality ..........................................................................................................................60
Report Publisher ......................................................................................................................................62
Chromatogram and other Plot Groups..................................................................................................65
Table Groups .........................................................................................................................................66
Calibration Curve Groups .....................................................................................................................66
Method Groups ......................................................................................................................................66
Drawing Object Groups ........................................................................................................................67
PDA/MS Groups ....................................................................................................................................67
System Suitability Groups......................................................................................................................68
Dissolution Groups ................................................................................................................................68
Pattern Match Groups ...........................................................................................................................68
Chemical Structure Groups ...................................................................................................................68
GPC Groups ..........................................................................................................................................69
Preview .....................................................................................................................................................69
QuickStart Interface ...............................................................................................................................70
Open Access User Interface ....................................................................................................................71
Empower 3 Software Options .................................................................................................................72
System Suitability Option.......................................................................................................................72
Processing and Reporting System Suitability Results ............................................................................72
Processing System Suitability Results ...................................................................................................72
Reporting System Suitability Results .....................................................................................................74
Pattern Matching Option (not available in Empower 3) .......................................................................74
AutoArchive Option ...............................................................................................................................75
Chemical Structures Option ..................................................................................................................75
Dissolution Option.................................................................................................................................76
Gas Chromatography (GC) Option .......................................................................................................76
Waters Data Converter Option..............................................................................................................77
Empower 3 Enterprise Options ..............................................................................................................77
Enterprise Data Manager (EDM) Option .............................................................................................77
Method Validation Manager Option .....................................................................................................77
Qualification Products ............................................................................................................................79
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Section 1 - Introduction
Basic Principles
Empower 3 Software is an information management application for chromatography data.
The application addresses a comprehensive range of corporate laboratory concerns:
1. Comprehensive Applications Support
2. Laboratory, Site and Enterprise Wide Information Management
3. Regulatory Compliance (GLP/GMP/ER/ES)
4. Maximizing Instrument and Application Availability
5. Minimizing System Downtime
6. Data Security, Change Control and Audit Trails

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7. Customization and Interaction with 3 Party Applications
What Makes Empower 3 Unique?

The unique properties of the Empower 3 application include:
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1. Empower 3 (As well as Empower and Millennium software) is the only data system
to fully utilize an integrated, relational database. With the Enterprise client/server
platform, the centralization of the database minimizes system management
requirements by allowing access to all information from a central location.
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2. Empower 3 (As well as Empower and Millennium software) provides the most
secure environment for the storage of information. Information that is not stored in an
isolated, secure environment is vulnerable to alteration, either deliberately or
accidentally.
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to provide a fully optimized implementation of client/server technology for both
hardware and software. Empower 3 uses a component-based architecture to allow
seamless division of the application across multiple computers.
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to provide a fully scalable architecture. By being able to scale up, Empower 3
Personal workstation customers are able to expand to the Enterprise architecture
without loss of investment while maintaining the same user interface. By being able to
scale down, Empower 3 Enterprise customers are able to maximize system uptime.
5. Empower 3 Enterprise extends the capability of the Empower 3 Personal

workstation and Workgroup products across a laboratory or enterprise.
1-1 Waters Corporation

Empower 3 Functionality
Multiple User Interfaces

The Empower 3 Software allows the user to choose the software interface that is appropriate
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for their individual requirements.
1. Pro – provides a look and feel that is similar to Millennium32 software; for Empower
3 users, system administrators and compliance managers.
2. Open Access – for walkup users that need to run and process samples on the fly.
Results can be emailed to appropriate individual(s).
3. QuickStart – simple, single window interface that optimizes access to available

functionality. Everything required to run samples and get answers is located in one
place. Takes the software’s performance features and makes them as accessible to
the occasional user as they are to the everyday user.
Central Database
Features Benefits
One central database supports multiple Minimizes system management and simpler
clients running the Empower 3 data archival. Each system management task
application. needs to be done only once.
One central location for all The user can create combined summary
chromatography information reports across labs, instruments and projects
without concern for where the data was
acquired or processed. The user does not need
to search for information in more than one
place.
Access and share information from Productivity is enhanced when information

multiple instruments, laboratories and can be shared easily. Laboratories can pass
sites easily. methods and information electronically.
Different sites can work with all the
information across an enterprise without
needing to worry about where the
information is stored.
Assistance with regulatory compliance All method information and raw data is
(GLP/GMP/ER/ES) stored with results. Nothing is overwritten
and all versions are available for review.
Audit trails allow traceability and proof of
modification or deletion. Specific features
have been implemented to allow compliance
with ER/ES (21 CRF Part 11) for customers
who must comply with FDA regulations.
Interact with the system where it is Access any information on the system from
appropriate and convenient for the any client computer. Work can be done
user. where it is most convenient. Laboratory
space can be utilized for instruments without
needing to use valuable bench space for
computers/clients.

Security and Regulatory Compliance 1

Features Benefits
Empower 3 user levels and logon Ensures that only valid users are able to
security. access the system and that each user can
do only what they should be allowed to do.
Electronic Record (ER) and Electronic Full compliance with the ER/ES rule of the
Signature (ES) compliant-ready FDA (21 CRF Part 11) ensures that
pharmaceutical laboratories can meet their
obligations to the regulatory authorities.
Fully Secure Sample, Method and All information (excluding the raw data)
Result information is stored in the database. Users do not
have access to this information without
authorization. Any changes to this
information can be audit trailed to ensure
traceability
Fully Secure Raw Data • Access to raw data is controlled by

the Waters Service. No user is able to
modify or delete raw data except
through the Waters Service, and then
only if authorized, and their actions
can be audit trailed.
• Raw data integrity algorithms assess

data each time it is fetched to
determine if the data has been
altered; either accidentally or
intentionally. If the data is found to
be modified from its original
contents, the chromatogram is not
displayed and en error is sent to the
Message Center.
Information is stored remotely from On an Enterprise client/server system,

the user information is not stored on the local hard
disk where the user can interact with it
using the operating system. The
information is stored on a remote, secure
server, with the remote user only having
access through all of the security of
Windows Server 2008 R2 and Windows 7
or Windows XP operating systems and
Empower 3.

Component-Based Architecture
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Features Benefits
Application load is balanced between Traditional workstation or LAN-based
hardware components. implementations of data systems burden
one of the system components more than
the others. This results in performance
that changes dramatically as the load on
the system changes. By optimizing the
load on each component of the Empower
3 Enterprise system, performance is
improved and remains essentially
constant under different loads.
Database operations are isolated and The server can be configured to allow
optimized on the server. the database to operate optimally. There
does not need to be a compromise to the
configuration to allow user interaction,
acquisition or other applications to run.
The server can be upgraded without
impacting on the other system
components.
Acquisition operations are isolated and The LAC/E32 Module can be

optimized on the LAC/E32 Module. configured to allow acquisition to
operate optimally. There does not need
to be a compromise to the configuration
to allow user interaction. More systems
can be run on a LAC/E32 Module than
can be run on a client, minimizing the
cost of acquisition.
Processing operations are performed Processing is done on the client when

where it is most appropriate. the user wants to interact with the data
or reprocess previously acquired
information. During normal “run and
report” while acquiring, processing is
done on the LAC/E32 Module. This
leaves more processing power available
at the client. The client can be logged
out or even turned off while acquisition,
processing, and online reporting can
continue.

Scalable Architecture
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Features Benefits
Scale up seamlessly from Personal Using the component-based architecture
workstation to Enterprise client/server. of Empower 3, customers can choose
whichever configuration is best for
them. Later they can scale up to an
Enterprise system without needing to
obsolete or trade-in any software or
hardware. No retraining is required.
Minimize downtime. With traditional data systems, if one

component fails, the system is
unavailable until the faulty component is
repaired. With an Empower 3 Enterprise
system, if one component fails, an
alternate component can be brought
online to ensure that downtime is
minimized and samples can continue to
be run. If the server fails, store data in a
local database. If an acquisition server
fails, perform acquisition locally.

Empower 3 Designed for the Enterprise

Empower 3 is an information management strategy for chromatography data.
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Empower 3 is a family of products or a technology, it is not just a piece of software. It comprises:
1. A base set of features (the application environment)
2. Available on industry standard platforms
3. A series of add-on applications from Waters to enhance functionality
4. The Empower Toolkit (Software Development Kit) for custom applications;

recognition that Waters cannot meet all the demands of the customers.
5. A series of partner applications to round out the functionality and make Empower 3
a true laboratory solution

Empower Scalability Strategy

Empower 3 software is comprised of 3 software components that work together. The user sees a single
application but the component-based nature of the software gives you the flexibility to create a wide variety
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of configurations to meet different business needs.
Acquisition
& Control
Database
Processing
& Reporting
In a Personal workstation, all components are present in the same PC. However, with Personal workstation
systems you must make a decision - you want convenience and availability but you also want to reduce the
cost. To get the best availability, it is ideal to have one system per workstation and, as you add more
systems, you add more workstations.
Note: the different software components in the following diagrams are abbreviated to a
single letter, P=Processing, D=Database and A=Acquisition.

To minimize cost, multi-system Personal workstations are available. The issue is that this strategy can
compromise the availability of the systems and the software due to the limited number of keyboards.
So, what can be done? Must there be a compromise and a less than optimal solution?
One option is to add processing stations where users could work to do data reduction. This adds more
keyboards without the cost of the acquisition component.

The problem has always been ‘how does the data get to the processing station’? This not only meant that
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the data had to be manually moved via floppy disk or network, it also meant there were multiple copies of
the data created. This solution has had limited applicability.
Empower 3 Workgroup solves this problem. The Workgroup configuration is small, client-server network
with a maximum of 10 named users. There is no limit to client computers and all can perform processing
and data acquisition. There is no limit to the number of LAC/E32 Modules you can use. There is no
manual transfer of data and only a single copy of data is required. This is a good solution where the
laboratory already has one or more workstations.
Empower 3 Workgroup provides a true multi-user, multi-keyboard solution with the LAC/E32 Module as
the ‘hub of the wheel’. It is important that the LAC/E32 Module can also process data so that the PC is not
burdened with anything that can be done somewhere else. Note how the building blocks are now being
moved around to accomplish business requirements without the user needing to worry about where the
different components are.

LAC/E32
Extending Empower 3 Workgroup creates an Enterprise system, which is a full-scale client/server

configuration. The Empower 3 Enterprise solution can be scaled to any number of instruments and users
across a laboratory, site, or an entire global enterprise. There is no magic to the Enterprise architecture—it
is just another way to configure Empower 3. Additional laboratories can be added at any time, and
processing stations can be put where they are best utilized rather than needing to be with the instruments.


So, no matter how a laboratory needs to grow, there is an Empower 3 configuration that will fit your needs.
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If you know that one day the lab would like to have an Enterprise system, you can head toward that goal
from the beginning - knowing that any investment is protected, that scaling up is just the addition of new
components and that your investment in training will be preserved. No other company can offer this and it
gives great comfort to the system owner knowing that their system can adapt to their changing
circumstances.
The scalability is also two-way—scaling down is sometimes a good idea; what happens if you have a
client/server system and…the server fails! If the only database resided on the server, then samples could
not be run until it was repaired. But, with the scalability of Empower 3, some clients can also have a
database and samples can run locally if the server is unavailable. When the server is available again, the
information is merged back into the central database.
But, what if the entire network is down? In that case some clients can also include acquisition capability.
Now everything can continue as if you had standard workstations.
The concept is simple but it means a great deal to a business. System availability is vital in the modern
laboratory and supporting these configurations allows Empower 3 to fit into existing IT infrastructure while
giving the system administrator the flexibility and peace of mind that they cannot get with any other
package.
Empower 3 is truly designed for the enterprise.
Rapid Deployment
For installation and upgrades, Empower Software provides the ability to remotely and silently push the
Empower client, Empower LAC/E32 module, and instrument control software. This allows an
administrator, sitting in one location, to easily and rapidly deploy software to locations which could be in
another room, another building, or another location anywhere in the world.
Empower Software also supports a full suite of qualification products and services to assist in the
qualification of your deployment.
Enterprise Authentication Using Active Directory (LDAP)

In order to enhance compliance with corporate security, Empower Software supports Enterprise
authentication using Microsoft Active Directory (LDAP). Wherever in the software that authentication is
required (log in, sign off, method modification, etc.), users can be directed to authenticate against the
corporate Active Directory server using LDAP.
Citrix Environments
Empower is supported in a Citrix Environment and is Citrix-Ready Certified. This means that in addition
to Waters structurally validating this type of deployment, Citrix has also reviewed and accepted Waters’
test results of performance in a Citrix environment as being acceptable.

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Section 2 - Technology
Licenses and Key Disks
Empower 3 utilizes electronic licenses to activate named user licenses, system licenses and software
options.
Note: With Empower 3, most licenses are specific to a single database instance
(Personal workstation, Workgroup or Enterprise, however multi-database named user
licenses are available.
The various types of licenses and options available, with information on their use is as follows:
Named User Licenses
Named User Licensing is used in Empower 3. Named user licensing is an easy licensing
scheme to understand and implement.
A named user is defined by Waters as any individual person who can access the Empower 3
software application. Each named user must have a license whether they are logged into
Empower 3 or not. An Empower 3 user can have a status of “Active”, “Disabled” or
“Removed”. A Named User is defined in Empower 3 as any Empower 3 user account with a
status of "Active" or "Disabled". "Removed" accounts do not count against the number of
Named User Licenses available to you. In addition, the "SYSTEM" account is a special
account and does not use a Named User License.
Named User licensing applies to all Empower 3 configurations - Personal, Workgroup and
Enterprise. All configurations are supplied with 5 Named User Licenses in the base
configuration. You may then purchase additional Named User Licenses to configure the
system for the required number of analysts. (The Empower 3 Workgroup configuration is
limited to a maximum of 10 named users.) Named User Licensing allows you to load the
Empower 3 client software on any number of computers.
Named User Licenses are activated using the Waters License Activation web site, and allow
additional active user accounts to be created, up to the number installed. These licenses are
available in multi-packs in increments of 1, 5, 20, or 50 users. These packs are splitable;
allowing you to specify the number of licenses to be installed at any given time on any given
database. Multi-database Named User licenses allow the activation of 1 Named User on each
of up to 10 different Empower 3 databases. To create a new user account once the license
limit is reached, you must either purchase more Named User Licenses or you must designate
one (or more) user accounts as "Removed" to make existing licenses available for
redeployment.
Named User Licenses may be deactivated (uninstalled) from one database so that they can be
transferred to another. You must ensure that you do not have more "Active" accounts than
licenses when this occurs. You can do this simply by flagging accounts as "Removed" until
they are within their license limits. If the number of active accounts exceeds the number of
licenses because licenses have been removed, the next time a login occurs, the license

violation will be detected and all non-Administrator accounts will be marked as "Removed".
A system administrator will then need to activate accounts up to your license limit to allow
users access to the system.
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With the exception of the Multi-database Named User License, each license can only be
installed on one database at a time. Upon activation, you can specify how many licenses, of
the total available in the multi-pack, to activate on a given database. The licenses remaining
in the multi-pack can be activated at another time on the same, or different database. User
Licenses are deactivated in the same number increments that they were originally
activated.Each Multi-database Named User License allows installation of 1 Named User
License on a given database. This license can be activated on 10 different databases for a
total of 10 Named users.
Base License
This type of license defines the type of platform (Personal, Workgroup, or Enterprise) to be
configured. One base license is required for every platform and, when activated, defines the
type of platform. This license must be deactivated if the system is to be reinstalled.
Deactivating this license, in turn, deactivates all other licenses and options activated in the
Empower 3 installation
The base license for Empower 3 Personal will also activate 5 Named User licenses and
either 1 system license (single system configuration) or 4 system licenses (multi-system
configuration) on the system where it is installed. The base license for Workgroup or
Enterprise will also activate 5 named user licenses but will not activate any system
licenses.
Client/Server and Workstation Specific Licenses
With the exception of Named User licenses and System licenses, most option licenses are
specific to the type of system on which they will be activated; Personal, Workgroup or
Enterprise. An Enterprise option license will not operate on a Personal workstation, and vice
versa. Software option licenses (e.g. GC, System Suitability, GPC / SEC, Toolkit, Method
Validation Manager, Chemical Structures, Dissolution, AutoArchive and Enterprise Data
Manager) activate the specified software option for one database (Personal workstation,
Workgroup or Enterprise as appropriate).
These licenses must be uninstalled if the software is to be reloaded.
Millennium32, Empower, and Empower 2 option key disks will not function in Empower 3.
Options Not Requiring Licenses
Detector options (e.g. PDA and MS) do not require licenses. The software option is always
enabled on each database as the appropriate detector is required to acquire this type of data.
System Licenses
A system is defined by Waters as a group of chromatographic instruments that are used

simultaneously to acquire chromatographic data. An Empower 3 System Control License is a
license that counts the number of online chromatographic systems connected to an acquisition
device such as an Ethernet or serial device or busLAC/E board in an Empower 3 Personal
configuration or a LAC/E32 Module in a Workgroup or Enterprise configuration. Only online

system must have a license. The number of online systems cannot exceed the number of
System Control Licenses activated within the Empower 3 environment. 2
System Control Licenses applies to all Empower 3 configurations - Personal, Workgroup and
Enterprise. System Control Licenses are integrated into the acquisition options available from
Waters. For Personal configurations, one System Control License is integrated into the single
system offerings and four System Control Licenses are integrated into multi-system offerings.
For Workgroup and Enterprise configurations, four System Control Licenses are integrated
into the Quad LAC/E32 Module configurations and two System Control Licenses are
integrated into the Dual LAC/E32 Module configurations. System Licenses are also available
for purchase separate from LAC/E32 Modules.
The Waters Service

The Waters Service is a Windows service that allows for secure data transfer of chromatographic data. Data
security concerns are minimized and the administration required for acquisition server modules becomes
transparent.
Once the Waters Service is enabled:
Microsoft DCOM does not need to be re-configured on acquisition servers, minimizing setup time.
Because Empower services are started by the System account of the local operating system, no
domain account is required by Empower 3, minimizing security concerns.
No User logon is required on any acquisition server, minimizing setup time and security concerns.
A secure hidden file share, Waters_Projects$ is used for Empower raw data files. Waters_Projects$ is
configured with all users having read-only access minimizing security issues.
Note: The Waters Service is used on the database server, the file server that provides the file share for
data files, and all client computers that acquire data except for Acquisition Clients that acquire data
from Mass Spectrometric detectors. The Waters Service should be disabled on Citrix application
servers.
The Waters Service implements file and COM services. These are packaged in the single Waters Service
application for simplicity. In addition to providing these facilities, the Waters Service application launches
the InstSrv application when it starts. Since a service can be configured to start automatically at machine
bootup, and since InstSrv boots the busLAC/E board if necessary, this time-consuming operation will
usually be complete before the first user tries to access instruments.
Data Acquisition and Buffering

On an Empower 3 acquisition server (LAC/E32 Module or acquisition client), two processes (INSTSRV and
CHROMSRV) are responsible for data acquisition and control. When the acquisition server is booted,
INSTSRV is started. INSTSRV then starts one CHROMSRV process for each configured, on-line system
on the acquisition server. Each CHROMSRV is dedicated to a particular chromatographic system.
When an Empower 3 client chromatographic system (the CHROMSRV application) acquires data destined
for a database on another machine in the network, it first writes the data locally to files. This includes data
destined for Oracle, and the chromatogram data files. As each injection completes, the chromatogram data
files for that injection are copied to the database server and, if the copy succeeds, the local copy is deleted.
At the successful end of a sample set, the file containing the Oracle data is also deleted.

If CHROMSRV is unable to transfer data to Oracle or copy files to the server, it continues to run but no
longer attempts to converse with Oracle or the server’s data directory. Data continues to be written locally
to files. CHROMSRV is said to be in “buffering mode”. It remains in “buffering mode” until the next
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sample injection. Before the next injection is done, CHROMSRV attempts to re-establish connection to the
database and, if successful, will send all buffered data to the database and will come out of buffering mode,
continuing operation as normal. If it fails to connect, the set continues but is run in “buffering mode”.
Every 10 minutes (approximately) after the end of the sample set (assuming buffering is still in progress),
INSTSRV examines the directory of local files and, if it finds a sample set or single injection in need of
recovery, tries to connect to the appropriate server and project. If the connection is successful, it transfers
the Oracle data from the local file to the remote Oracle database, and copies local data files to the proper
directory on the file server. If the copy is successful the local copies are deleted.
How Oracle and Server Failures are Recognized
CHROMSRV uses the normal Empower 3 calls to store Sample Sets, Injections, Chromatograms and so
forth in the database. When one of these fails, as would be the case when Oracle is not reachable, the call
returns an error. If CHROMSRV sees an error, it goes into “buffering mode”. CHROMSRV likewise uses
Empower 3 calls to write and copy files. These in turn use the underlying Microsoft file routines. So if one
of these Microsoft routines were to report a failure, CHROMSRV would also go into “buffering mode”.

Local Directory and File Organization
The Oracle destined data is kept in a file named SampSetxxxx.dat where xxxx is a number corresponding
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to the Sample Set’s Identifier in Oracle. The chromatogram data is kept in files named Dxxxx.dat where the
xxxx likewise corresponds to the Oracle channel (chromatogram) identifier. These files can be found in a
directory named Empower 3\InstrumentServer on the acquisition server. This directory is in turn organized
into subdirectories organized by System, Database Server, and Project. So, for example, the following file
would indicate that System “MySystem” is acquiring data destined for server “MyServer” and project
“MyProject”. If Oracle were currently reachable you would see a Sample Set with identifier 1234 in the
Project application’s Sample Set view.
\Empower 3\InstrumentServer\MySystem\MyServer\MyProject\SampSet1234.dat
A similar technique is used for single injections, but an empty file named Singlexxxx.dat is used in place of
SampSetxxxx.dat. The file simply indicates that there is a matching Dxxxx.dat file being acquired or in
need of recovery.
How Identifiers are Assigned
If the Oracle database server is reachable, the Oracle entries for Sample Sets and Chromatograms are made
directly into Oracle and the identifier assigned by Oracle is used. These tend to be large numbers
(identifiers start at 1000). If Oracle is not reachable, CHROMSRV assigns a local identifier by simply
incrementing a counter that starts at 1. In other words, these files have low numbers like SampSet4.dat and
D12.dat. During recovery, CHROMSRV asks Oracle to make entries for, and assign actual identifiers to
items it had to identify locally.
The timestamps used for injections use the same technique – if the Oracle database server is reachable then
Oracle’s data/time is used. If not, the local machine’s date/time is used until the server is available.
Empower 3 and Date Handling
How Empower 3 Handles Dates
Empower 3 stores dates internally and operates using both Oracle and Microsoft date formats and date
handling routines. These formats are summarized below. Empower 3 does all date arithmetic and
comparison using these internal formats, so the number of digits used to display the year is irrelevant. In
other words, there is no year 2000 problem.
Dates are formatted and displayed using Microsoft formatting routines. The format is specified via the
Microsoft Control Panel settings. So a user could, for example, choose a date format that represented the
year as 2 digits. In this case, a year of “00” could appear on the screen or in a report. But again, that’s not
what is stored or used for computing. Changing the control panel to a 4-digit date representation would
change the display to “2000”.
The one place where date formats can cause unexpected behavior is in user specified view filters. Filters
can be specified to select dates before or after a specified one. For example, “>3/3/97” means “dates greater
than March 3, 1997.” Empower 3 uses the Oracle 11g conventions in view filters, where Oracle defaults 2
digit years to the century “20”. In this example, the view filter would not show new rows (i.e. rows with
years like 00 or 01). The actual data is still stored properly, and a user can remedy the problem by
specifying a 4-digit date in the view filter.
Oracle Date Format

Oracle represents dates using one byte each for century, year, month, day, hour, minute and second. This
format supports dates ranging from January 1, 4712 BC through December 31, 4712 AD with 1 second
resolution.
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Microsoft Date Format
Microsoft represents dates using an 8 byte floating point number with December 30 1899 at midnight being
the number 0.00. So, for example, January 4, 1900 at noon is internally represented as the floating point
number 5.50. This format and related Microsoft routines support dates ranging from January 1, 100 to
December 31, 9999 with an approximate resolution of 1 millisecond.
Where Do The Dates Come From?
The following table shows the place of origin of Empower 3 dates in a Workgroup or Enterprise
environment (on a Personal workstation everything is based on the local PC clock). Note that a client in this
case is either a processing client or an acquisition server (e.g. LAC/E32 Module).
Item Normal Operation Buffering Mode Note

Date Acquired Server Client 1,4
Date Processed Server N/A
Date Calibrated Server N/A
Sample Set Start Date Server Client 4
Sample Set Finish Date Server Client 4
Result Set Date Server N/A
Library Create Date Server N/A
Method Create Date Server N/A
Current Date (Report) Client N/A 2,4
Sign Off Date 1 Client N/A 4
Sign Off Date 2 Client N/A 4
Data File Create Date Server Server 3
(DXXXX.DAT)
Project Create Date Server N/A
Project Last Archived Date Client N/A 4
Notes:
1. When Empower 3 is buffering data acquisition (due to a loss of communication

with the server) there is the potential for a lengthy delay between the acquisition of
a sample and its later storage on the server. In this case the local client internal
clock is used to determine Date Acquired.
2. The system create date must be the client internal clock date since the system is
created by the InstSrv process. Because this process does not communicate to the
database, it must use the local internal clock.
3. The data file creation date is the date at which the data file was placed onto the
server hard disk and is the system date and time. Since the file may be placed on the
server sometime after acquisition is complete when in buffering mode, the "Date
Acquired" field and the data file creation date may not be similar. This is normal
behavior when buffering has occurred.
4. The Client clock can easily and automatically be synchronized with a time server on
the network. This will ensure that the same time is reported for both the server and
the client, avoiding any confusion over time stamps.

Empower 3 Use of Oracle Tablespaces

Empower 3 Software contains an Oracle database, which is fully integrated into the application. This
2
approach was designed to offer enterprise grade Oracle technology without requiring additional IT
resources to manage it. Oracle considers an Embedded License Application (such as Empower 3) to be an
application where the database is truly embedded into the application and the customer has little or no
knowledge that the Oracle database exists in the application. Waters does not grant an Oracle license—
Waters grants to Empower 3 users the use of Waters’ Oracle license under a sub-license distribution
agreement with Oracle.
The Empower 3 application has been designed and developed by Waters to eliminate program
administration tasks by the customer. This is done by enabling centralized and remote administration and
by including built in program administration functions. All administration scripts including startup,
shutdown, and backup are provided by Waters and reside within the application program. In addition, all
support for program operations are provided by Waters.
Additional information is located in the following documents located on the Empower 3 Documentation
Bookshelf (part number 667004162):
- Empower 3 Software System Administrator’s Guide
- Empower 3 System Installation and Configuration Guide
Oracle organizes data in logical units called “Tablespaces.” Oracle allows a tablespace to occupy multiple
disk files, but for simplicity Empower 3 uses only a single file per tablespace. In the default example, these
tablespaces/files are:
Tablespace File (in database-

drive:\EmpowerDatabase\oradata\WAT11)
System \SYSTEM01.DBF
Undo UndoTBS01.DBF
Index INDEX0n.DBF, where n = 1 - 9
Temporary TEMP01.DBF
System Auxillary SYSAUX01.DBF
User/Project USERS0n.DBF, where n = 1 - 9
The initial size of these tablespaces is determined by the Empower 3 Installer and is based on the type of
configuration. As tablespace is used, Oracle will automatically extend the size of a file by a specified
increment up to the maximum size specified by the application.
Oracle uses the Temporary tablespace to sort rows and do other internal housekeeping. When the sort is
complete, Oracle frees the storage. The amount of temporary storage used goes up and down, but it will not
exceed the maximum allowed file size.
When Oracle adds or removes items, it does so using a “Transaction”. A transaction is something that
either runs to completion or not at all. So, for example, when you store a result with 10 peaks, either all 10
peaks are stored, or none at all. This is true, for example, even if the system’s power is turned off after
only 3 of the 10 peaks are stored. When Oracle restarts, it will “roll back” the transaction as if in never
happened. In order to enforce a transaction, Oracle must keep track of what it is doing so it can be undone,
if needed. Oracle does this with Undo Segments that reside in the Undo Tablespace. Much like the
temporary tablespace, the amount of storage used goes up and down because Oracle can free the storage
once the transaction is complete. It should only rarely be necessary to change the Undo Tablespace settings,
which should not be changed unless Oracle reports errors.
Oracle uses the System Tablespace to remember which tablespaces, tables, projects, and indexes it is
managing. The actual data for these items (projects for example) is stored in other tablespaces, but

information about the items is stored here. It is unlikely that there will be a need to change the System
Tablespace settings. In a very large installation with hundreds of projects, the user may get an Oracle
warning referencing System tablespace when they try to create or restore a project. The system tablespace
2
can be managed via the Oracle Enterprise Manager (OEM) storage management console
Oracle uses the Index Tablespace to cross-index information within the database to improve performance.
For example, when the user wants to see all the peaks from a particular result Oracle can find them much
faster if it has an index relating peaks to results. This is analogous to looking up someone’s phone number.
If you know their name, it’s easy to find the number because a phone book is indexed by name. Finding
someone’s name given his or her number is much harder because you have to search the entire book. The
amount of Index tablespace used should be roughly proportional the amount of Project tablespace used. As
new items are added to a project, Oracle adds new indexes for them. The system administrator should
occasionally check how much Index tablespace is used, but remember that Oracle will automatically
increase it up to the application specified maximum. The OEM will provide access to manage the storage
within the database.
The majority of the application data is held in the Project Tablespace. This is somewhat of a misnomer
because in addition to Project data, it also contains library and spectral data and information about
Empower 3 users, groups, and systems. Note that the raw chromatogram files themselves are not stored in
the Oracle database; they are kept in files outside of Oracle. The system administrator should occasionally
check how much Project tablespace is used, but remember that Oracle will automatically increase it up to
the application specified maximum.
By default there are 9 Project Tablespace files named USERS0n.DBF, where n = 1 – 9 that all projects
use as they need. The tablespace number you enter when creating a project, or see when you view project
properties is simply a quota. Its only purpose is to keep a given project from using up an excessive amount
of the project tablespace. There is no performance or storage price to be paid for changing it or for making
it large initially. You don’t pay until you actually use the storage. Think of it as a credit limit on your
charge card.
Application Components
Empower 3 uses a component-based architecture with three main components, a Processing server, an
Acquisition server and the Oracle Database server. Many different Empower 3 executable files
communicate with these components, on the same or difference machines, to present the Empower 3
application to the user.
The different components and applications are shown in the following diagram:

Empower 3 Executables
2
Processing Server
Acquisition Server
Oracle Database Server
Oracle TNS Listener
Oracle
Windows Operating System
TCP/IP
Network Interface Card
Communication between the Empower 3 executable files, processing server, acquisition server and Oracle
database server uses COM when the components are within the same machine and DCOM when the
components are remote (on different machines).
During database access (for example when processing a sample), the communication between the client and
the server is as shown below:
Processing Server
Acquisition Server
Oracle Database Server Oracle Database Server
Oracle TNS Listener Oracle TNS Listener
Oracle Oracle
Windows Operating System Windows Operating System
TCP/IP TCP/IP
Network Interface Card Network Interface Card
Client Server
When accessing raw data files (for example when writing the data file after acquisition), the
communication between the client and the server is shown as follows. In this case, communication uses
standard operating system calls to send and receive raw data. TCP/IP security is used to determine whether
the raw data file was successfully delivered to the client or the server (as appropriate).

2
Processing Server
Acquisition Server
Oracle Database Server Oracle Database Server
Oracle TNS Listener Oracle TNS Listener
Oracle Oracle
Windows Operating System Windows Operating System
TCP/IP TCP/IP
Network Interface Card Network Interface Card
Client Server
Empower 3 ‘Servers’
Instrument Server
An Instrument Server controls a single chromatography system. An instrument server allows clients to
observe and control instruments that make up the system. It can carry out a single injection or a sequence of
injections. It saves acquired chromatograms locally via a local Storage Server. In some configurations, it
may transfer these chromatograms to a remote Storage Server at the end of each injection. It may ask the
Processing Server to process and report on each injection’s worth of chromatograms. It may also ask the
Processing Server if it can continue with the next injection (e.g. when using interactive suitability, a “must
peak”, etc.).
The major services it provides are:
• Get configuration information (instrument type, head size, options installed, etc.)
• Get instrument status (current temperatures, flows, states, etc...)
• Get instrument real-time data
• Set instrument conditions per a specified Instrument Method.
• Perform an injection
• Run a sample set’s worth of injections
• Configure a system out of modular instruments
• Interactively control instruments (auto zero, run diagnostics, etc..)
Processing Server

A Processing Server processes an injection’s worth of chromatograms to produce results and (optionally)
reports. It can also be asked to do special things like “Clear Calibration.” The Instrument Server asks it to
do these things. The Instrument Server can also ask whether, as a result of the processing, it should
2
continue with the next injection or not. A third party application can “hook into” processing to compute the
value of some custom result fields.
The major services it provides are:
• Process and Report on an Injection
• Perform a Processing Function
• Evaluate and determine if it is OK to Continue
• Hook processing (after results computed, but before reported)

..
.. Empower 3 Functionality Version 4.0
..
..
..
3
Section 3 – Functionality
Definitions
This section presents acronyms and definitions of terms used in this document. Other terms are
explained in context through the document.
Term Definition
baseline A line drawn from the start point of a peak to end point of peak –
needed to calculate peak area or peak height.
baseline noise Short-term fluctuations in a detector baseline signal that are due to
background electrical noise and other environmental variations. The
interference keeps the baseline from being perfectly flat.
bracketing The technique of running standards before and after and/or
interspersed with samples in a sample set to construct one or more
calibration curves. Each calibration curve is then used to determine
the concentration or amount of the samples that are ‘bracketed’ by the
standards. This technique can help to compensate for variations in
chromatography caused changes in temperature, flow, or solvent
evaporation that may occur during the course of injecting a set of
samples.
chromatographic run A set of standards and/or samples injected during the same
chromatographic experiment.
EP European Pharmacopoeia
exponential skim A method of resolving small rider or shoulder peaks from a larger
peak by estimating the shape of the larger peak using an exponential
function.
JP Japanese Pharmacopoeia
peak area The detector response (reported in units of µV-seconds or equivalent)
integrated over time between the start-of-peak and end-of-peak points
minus the baseline.
peak height The detector response (reported in units of µV or equivalent)
measured between the apex of the peak and the baseline value
measured at the same run time.
peak name The name assigned by the user to components eluting at a given
response time.
retention time The elution time of a component at the apex of the peak.
selectivity A measure of the relative retention on a chromatographic column of
two components under the same mobile phase and stationary phase
conditions.
sequence A set of standards and/or samples injected during the same
chromatographic experiment.
SOP Standard Operating Procedure
tangential skim A method of resolving rider or shoulder peaks from a larger parent
peak by drawing a (straight) line to tangentially skim the rider peak
from the parent peak.
USP United States Pharmacopoeia

General 3
Empower 3 General Description
Empower 3 Software is a 32-bit data management application with advanced integrated database
architecture using a 64-bit Oracle database. It acquires, processes, reports, and manages
chromatographic information. Empower 3 offers easy-to-use technology and converts high-
quality, accurate results into usable information while meeting security and regulatory compliance
requirements. It is a complete chromatography and results management system that you can adapt
to your individual chromatography requirements by using as many or as few Empower 3 software
capabilities as you require.
Empower 3 is available in different configurations:
The Empower 3 Personal workstation is a stand-alone, single-user personal computer. It uses a

variety of acquisition interfaces (busLAC/E card, serial, and ethernet interfaces) and a local
database that supports the Empower 3 chromatography application software to acquire, process,
report, and manage chromatographic information. You can connect up to four online
chromatographic systems to an Empower 3 workstation.
The Empower 3 Workgroup is a small enterprise client/server system with a maximum of ten
Named Users. There is no limit to the number of LACE32 Modules (a network device dedicated to
chromatographic instrument control and data acquisition) that can be configured and used. Each
LACE32 Module or acquisition client (a client computer that is configured with chromatographic
instruments) can be connected to up to four online chromatographic systems.
The Empower 3 Enterprise system is a corporate-wide networked version of the Empower 3

application where there are no hard-coded limits to the number of nodes, users, or
chromatographic systems that can be deployed.
Three different user interfaces are available:
• Empower 3 Pro - provides access to all features of the Empower 3 software. This interface is
similar to that of Millennium32 and will therefore be familiar to Millennium32 users.
• Empower 3 Open Access - provides access to the features of Empower 3 software required in
an environment used for routine analysis or analytical services; one with many infrequent/new
users and/or ‘walkup’ users.
• Empower 3 QuickStart - provides a streamlined interface to the main features of Empower 3

software with an emphasis on simplicity and ease of use.
All interfaces are supplied in the base Empower 3 software application. Users can choose the
interface to log in to within the login dialog. A default interface is defined for each user, so that
the user’s preferred interface does not have to be explicitly chosen at each log in.
Function Build
Empower is a 32-bit Microsoft Windows application. 1154
Empower is available in English, Japanese, Chinese, and Korean versions. 1154
Empower is based around an Oracle database. 1154
No data is overwritten in the Empower 3 database. 1154

Using Empower software, you can: 1154

Acquire data and control chromatographic instrumentation
Process data interactively or in the background
3
Customize management of project information
Customize report design and generation
Using Empower software you can easily perform simple acquisition and 1154
processing requirements such as:
Making a single injection
Processing data
Printing a report
Using Empower you can perform sophisticated applications such as: 1154
Interactively creating and acquiring sample sets
Defining custom reports
Creating and adding custom fields, and calculating custom database results
Performing tracking and trending of results using the Empower 3 database
Empower development and testing follows a documented software development 1154
lifecycle (SDLC).
Empower Software is ISO 9001 TickIT certified. 1154
Comprehensive, context-sensitive Windows online help is supplied with the 1154
Empower application.
Waters maintains all development documentation, including Requirements, 1154
Functional Specifications, Source Code, Test Protocols and other information
related to product life cycle.
Source code for each version of Empower is available in an Escrow Account. 1154
Automated qualification is available for Empower workstations, clients and 1154
acquisition servers.
Custom programs that interact with or control Empower may be written using the 1154
Empower Toolkit. The Toolkit is a programming interface to Empower
functionality.
Multiple Toolkit applications may be run at the same time to accomplish 1154
different tasks.
The Toolkit supports any programming language that supports Microsoft 1154
standards such as ActiveX and COM (for example: Visual Basic, VBA, Visual
C++ etc.).
The Toolkit allows applications to be configured into the Empower user interface 1154
by adding menu items to various Empower windows as required.
As a product, the Empower LIMS Interface provides a seamless interface to 1154
LIMS systems. Specific LIMS systems/formats supported include:
ASCII
AIA (ANDI)
PE SQL*LIMS
LabSystems LabManager LIMS
The Empower LIMS interface is no longer offered as a product, but is made 2154
available as an example program in the Empower Toolkit Option
Report/Preview can be launched with a specified report. The Project object 2154 FR3
Launch Mil App Method has an argument allowing the programmer to specify a
report method.
Toolkit allows access to the “Next Service Due” field using a new object. This 2154 FR3
allows a Toolkit user to modify this field as required.
Toolkit allows access to Injections. 2154 FR3
Toolkit now allows access to Custom fields. 2154 FR3
View Filters (including new Method Validation Manager view filters and 2154 FR3
Method Validation Manager fields in existing view filters) are accessible via
Toolkit. Additionally, the view filter list for both public and private view filters
can be fetched for the current logged in user.

3
Installation, Configuration and System Management
Configuration Manager
The Configuration Manager is a graphical user interface that provides system management
functions to control various parts of the Empower 3 software. These functions include managing:
• Project information
• Custom fields
• Acquisition servers (configuring local and network acquisition servers)
• Chromatographic systems (creating and configuring local and network systems)
• Spectral libraries
• Library spectra
• Users
• User groups
• User types and access privileges
• The System/Project Audit Trail
• Plate types for injections
• Default strings
• System policies
• Electronic Signatures
• Electronic Records
• ACQUITY eCord-based column information
Function Build
Users with the appropriate privilege can remotely reboot LAC/E32 Modules. 1154
The display of information can be customized with default or user-defined view 1154
filters to determine the fields, criteria, and the order in which data is displayed.
Configuration actions allow the use of standard drag-and-drop, display, selection, 1154
and cut-and-paste code functions.
Configuration information is displayed in tabular format. Table columns can be 1154
sorted in ascending and descending order and tables can be printed.
All Empower objects selected may be deleted via a ‘Yes to All’ button added to the 1154
delete warning dialog, or the user will have the choice of deleting each object
selected ‘Yes’ or ‘No’, or they may ‘Cancel’ all together.
Preferences can be copied between users and projects on a per-user and per-project 1154
basis. Preferences can be copied during project creation or using the View > Copy
Preferences menu in Configuration Manager.
The ConnectionsAQT option (if present) is available from Configuration Manager. 1154
The System Monitor application is available from Configuration Manager. 1154
Allow entry of serial number during installation of software options. 2154
Export/Import of Systems Objects: 2154
Allow the transfer of Empower Nodes, Systems Users, User Groups, User Types,
System Audit Trail, Project Archives and Sample Archive, System Policies, View
filters to another database
Ability to Export System Object Information to a text file, including: 2154
> Users (incl: user type, interfaces, user groups)
> User Groups (incl: members, access to projects and systems)

> User Types (incl: privileges)

> Systems (incl: instrument info, access)
> Acquisition Servers (incl: instrument info, serial ports, access)
3
Max Rows in the table view of the Configuration Manager or Project window: set 2154
the maximum rows of data to be displayed at one time. By using the paging buttons
that are located at the top of the window, you can easily view data in a table. This
feature also works with view filters.
Ability to import legacy MassLynx MS/MS data 2154
On-line Help converted to HTML. Also includes task-based assistance. 2154
Support for task-based assistance discontinued. 2154 FR5
Closer Integration with NuGenesis SDMS: 2154
> Manual project push
> Archive when projects are deleted
> Archive of report after sign-off
You can import plate type definitions from a text file into 2154 FR5
Empower.
Projects
An Empower Project is a user-defined collection of methods, results, peaks, custom fields, peak
information, and raw data that are related and that reside in the Empower 3 database under a single
project name. Methods, results, and custom fields are stored in a reserved area of tablespace
within the Empower 3 database and raw data are stored in a separate area on the hard drive.
Function Build
Project raw data can be stored in multiple locations determined by users with the 1154
appropriate privilege.
Projects may be locked. 1154
Projects may have the following actions performed on them: 1154
Open
Backup and Restore
Create, Clone and Delete
Rename and change Properties
All actions performed on projects are tracked in the System Audit Trail. 1154
One or more projects may be restored at one time. 1154
One or more projects may be backed up at one time. 1154
During backup, the project name, backup comments, backup type, user who 1154
performed the backup, date and time of backup, current project quota and current
free space are serialized into a file which is part of the backup set.
During backup, the version of software in which the project was backed up is 1154
tracked. Upon restore, the version from the backup is documented in the System
Audit Trail entry.
Empower does not require a specific backup utility but the user has the option to 1154
configure a backup utility into the backup process.
Project backup will take all information within a project and place it in a specified 1154
location.
Project restore will take all information from a backup set and restore the project to 1154
the state at which it was at the time of backup.
Projects may only be deleted from the Empower database by a user who has the 1154
“Delete Project” privilege.
Audit trail settings must be configured when a project is created. These settings 1154
cannot be altered after creation is complete.
When a new project is created, the maximum size a project is allowed to grow to 1154
must be specified.

Access to a project may be limited to the project owner, a specified set of user 1154
groups or the project may be available to all users.
If access to a project is given to a group or to all users, the access can be limited to 1154
3
a specified set of privileges or can be whatever privileges the particular user has for
their account.
When a new project is created, specified information on methods, custom fields 1154
and/or views can be copied from another, template project.
The owner of a project can be changed. 1154
The current space taken by the project can be viewed. 1154
Options can be enabled or disabled on a project basis. 1154
Custom fields can be added, modified or deleted from projects. 1154
The users or groups who have access to the project can be changed. 1154
The maximum space the project is allowed to use can be increased or decreased. 1154
A “Number of Digits of Precision Displayed for Area and Height” setting is 1154
available to control the precision used for display of the following fields:
Minimum Area and Minimum Height parameters of the processing method, Area,
Height, Start height and End Height, Total Area, Slice Area (GPC), Slice Height
(GPC), Area Rejection (located in Table properties of a reporting table group), and
the Value field in the Integration Events table of a processing method. (The Value
field in the integration events table has a precision of either 3 or the number
specified in the “Number of Digits of Precision for Area and Height” field,
whichever is greater.)
Software options can be enabled/disabled during project creation in the New 1154
Project Wizard – Options page.
If a single project is selected, multiple copies of the project can be created in a 1154
single operation.
If multiple projects are selected, a single copy of each project will be created with a 1154
single operation.
Project Hierarchies: Projects can have sub-projects, just as Windows folders can 2154
have subfolders. A sub-project is simply a project which has another project as a
parent. This will allow users to better manage project naming and access,
particularly in large Enterprise environments.
Three project lock settings: 2154
> Full Lock - prevents access to project
> Read Only Lock - allows those users with access to open and view existing data
and methods. No new acquisition or processing can take place
> Process Only Lock - allows those users with access to open, view and process
existing data with existing methods. No new acquisition can take place
Check and Record Project Integrity: 2154
Provide additional level of confidence that the information believed to be contained
in the project may be reliably and completely retrieved. Checksums of the *.EXP,
*.INF files will be produced upon project backup and verified upon restore. Will
also ensure that for each Channel ID given, a raw data file exists and is checksum
verified.
A choice of shallow copy of methods is allowed when either creating a new project 2154
or cloning a project.
Project integrity errors will not require manual intervention in order to continue Empower
batch Project Backup or Restore. A log file is generated to document these errors. 3
Users
A user is an individual with access to the Empower 3 system. Users have accounts and privileges
that control the level of access to functions in Empower 3 software.
Function Build

User accounts may be set to one of the following three status conditions: 1154
Active
Disabled
3
Removed
Only “Active” user accounts may be used to login to the Empower application. 1154
A user account may include the full name of the user. 1154
User accounts may require a password to be used when logging in. 1154
Each user account must be assigned privileges based on a specific user type. 1154
There is no limit to the number of users that can be created provided that an 1154
adequate number of user licenses have been installed.
Allowed software user interfaces (QuickStart, Pro, Open Access, Web, and System 1154
Default) can be defined for each user.
A default user interface can be defined for each user. This interface will be logged 1154
into by default for that user unless the user selects a different interface by clicking
the Advanced >> button in the Login Dialog box.
For databases upgraded to Empower from Millennium32, the default user interface 1154
is set to Pro. For new installations of Empower 3, the default user interface is set to
QuickStart.
Allow a user to have multiple User Types 2154
The Web User Interface is discontinued 2154 FR5
User Groups
A user group is a set of users with access to the same projects. Members of a user group are
displayed in the User Groups view of the Configuration Manager.
Function Build
A Group Administrator that can modify users only in their group can be defined. 1154
User groups are supported to simplify assigning access to projects and acquisition 1154
servers.
There is no limit to the number of User Groups that may be defined. 1154
User Types
A user type is a way of characterizing users and specifying the access privileges for that Empower
3 software user. When you create a new user account, you provide access privileges to the new
user by assigning a user type to that user. User types are completely customizable, and there is no
limit to the number of user types you can create.
Function Build
User Types are supported to define access privileges for individual users. 1154
There is no limit to the number of User Types that may be defined. 1154
By default, the Chemist user type no longer has the following privileges: 2154
• Delete Data
• Delete Results
• Delete Projects
Acquisition Servers
An Acquisition Server is a device (usually containing a serial card, serial hub, Ethernet card, or
busLAC/E card supported for backwards compatibility with legacy instruments) that is capable of
chromatographic instrument control and data acquisition.
Function Build

When an acquisition server is defined, access to that acquisition server may be 1154
given to the system owner only, to the owner and selected user groups or to all
users.
3
Up to 4 computer serial (COM) ports may be used to connect instruments to an 1154
acquisition server.
Up to 8 serial ports on an 8-Port Serial Card may be used to connect instruments to 1154
an acquisition server.
An acquisition server may be password protected to prevent unauthorized 1154
reconfiguration.
An acquisition server can connect to a chromatographic instrument using IEEE or 1154
serial connection (depending on the device).
IEEE instrument connection is done using the Waters busLAC/E card. 1154
You can control up to four simultaneously online chromatographic systems in an 1154
Empower Personal workstation or a Workgroup/Enterprise acquisition client or
LAC/E32 Module. You can control up to eight simultaneously online
chromatographic systems when using a LAC/E32 Module.
Note: These system limits are the total allowed for all interfaces – busLAC/E, 8-
port serial card, hub, and COM ports. More than one interface can run
simultaneously.
Acquisition Servers are now called Empower Nodes. Citrix clients appear as 2154
Empower Nodes.
System Control is limited to a maximum of 4 systems per Empower Node. 2154
The 8-Port Serial Hub may be used to connect instruments to an acquisition server. 2154
Systems
A system is a set of chromatographic instruments, such as a pump, autosampler, and detector, that
function together to produce data.
Function Build
Individual chromatographic instrument components may be configured into an 1154
Empower system.
There are no limits to the number of chromatographic systems that can be 1154
configured in Empower software.
Instrument components may be used in more than one Empower system. 1154
Empower systems can be defined as ‘On-Line’ or ‘Off-Line’. 1154
Only ‘On-Line’ systems can be used to run samples. 1154
‘Off-Line’ systems can be used to hold definitions of systems that may not 1154
currently be actively configured to run samples or may be systems that are not
currently connected and powered on an Empower acquisition server.
A System cannot be taken ‘Off-Line’ if any users are currently connected to it or if 1154
the system is currently acquiring samples.
A System cannot be brought ‘On-Line’ if any of the components in the system are 1154
currently configured in another ‘On-Line’ system or if any component is not
currently available.
When a chromatographic system is defined, access to that acquisition server may 1154
be given to the system owner only, to the owner and selected user groups or to all
users.
Chromatographic systems may be password protected to prevent unauthorized 1154
access.
Empower controls the following Waters HPLC pumps and solvent management 1154
systems:
• 501(PCM/PCM II)
• 510(PCM/PCM II)

• 515(PCM/PCM II)
• 525 (PCM/PCM II)
• 600
3
• 625
• 626
• 2690/2695/2690D
• 2790/2795
Empower controls the following Waters HPLC detectors: 1154
• 410
• 486
• 474
• 2487
• 2410
• 996
• 2996
Empower controls the following Waters HPLC autosamplers: 1154
• 717
• 2690/2695/2690D
• 2790/2795
Empower controls the following non-Waters equipment: 1154
• Agilent 5890 GC
• Agilent 7673 GC Autosampler
• Agilent 6890 GC
• Agilent 6850 GC
• Agilent HS7694 Headspace Analyzer
• Agilent 1100 system
Empower controls the following other equipment 1154
• Waters ZQ 2000/4000
When using a controlled autosampler, the system automatically captures all vial 1154
information, including number, position, volume, and number of injections. If a
non-controlled autosampler is used, BCD input may be configured to confirm vial
number.
Column temperature may be controlled through the use of integrated column 1154
heaters in the 600, 625, 626, 2690, 2790, through the use of an external column
heater attached to a 410 or 2410 detector, or a Waters Temperature Control Module
(TCM/TCM II).
More than one detector may be configured in a single chromatography system. 1154
These detectors will use the same time base, and will be related to each other
through their injection ID.
Multiple detector channels from the same injection may be processed as a unit, 1154
using the same or different processing parameters. The channels may also be
displayed on screen by selecting their common injection and entering review. The
channels may also be included on the same report by creating a summary report
based on injection.
Data acquisition rates available are 0.25, 1, 2, 5, 10, 20, 25, 50, or 100 data points 1154
per second, depending on detector capabilities.
Controlled instruments with digital data collection can handle the full dynamic 1154
range of the detectors. Analog instruments will connect to a SAT/IN interface,
which can handle a range from –0.25 to 2.25 volts.
Support for Waters e-SAT/IN module 1154 ISSP
Instrument support discontinued as of Empower, build 1154: 1154
• 700, 710, and 712 autosamplers
• 715 autosampler
• LC Module 1

Instrument support in Empower 2 – please refer to the Empower 2 FR5 Installation 2154 FR5
and Configuration Guide
Instrument support discontinued as of Empower 2: 2154
3
• Integrity TMD mass spec detector
• ISA busLAC/E board
• GPC 2000
• 5890 GC under busLAC/E control
• 7673 autoinjector controller under busLAC/E control
Instrument support in Empower 3 – please refer to the Empower 3 Installation and Empower
Configuration Guide 3
Instrument support discontinued as of Empower 3: Empower
• 410 Refractive Index detector 3
• 486 Tunable UV detector
• 996 Photodiode Array detector
• 474 Fluorescence detector

Default Strings
Default Strings are phrases or series of words that are used as default text selections in several
Empower 3 categories that you specify. Default strings save time by eliminating the need to type
3
recurring comments and descriptions. After you create default strings, you can select them from a
drop-down list box in the functional area in which they are available.
Function Build
Default strings can be created to minimize the typing required in the following 1154
sections of the Empower application:
• Changes to System Objects Comments
• Component Names
• Custom Field Revision Comments
• Deletion Comments
• Export method Revision Comments
• Generic Method Revision Comments
• Instrument method Revision Comments
• Manual calibration revision Comments
• Manual result revision Comments
• Method Set Revision Comments
• Report Method Revision Comments
• Result Signoff 1 Meanings
• Result Signoff 2 Meanings
• Sample Information Revision Comments
• Sample Set Method Revision Comments
• Sample Set Method Template Revision Comments
Where default strings can be selected within the application, the user will have the 1154
option to type a response that is not available in the default string list.
The default string drop down list is initially blank (to prevent the user from simply 1154
clicking OK to accept the default).
Spaces only are not allowed for an audit trail comment. 1154
Privileges
Privileges are the authority assigned to a user to access specified Empower 3 software screens
and/or functions. Each privilege defines an allowed action within the Empower 3 application. The
user type assigned to a user account determines the available privileges.
Function Build
Privileges are defined to limit access to different functions or sections of the 1154
Empower application.
Privileges are sufficiently granular to ensure that object (item) creation, 1154
modification and deletion can be set separately.
Privileges are based on functions that can be performed and not on user interface 1154
elements of the software. This minimizes the complexity of configuration.
Privilege settings are not required based on operating system settings or disk 1154
structures.
The “Administrator” privilege assigns all Empower privileges to a user. 1154
The “Archive and Remove Audit Trails” privilege specifies that a user can archive and 1154
remove System Audit Trail records and save them as binary or text files. Archiving and
removing audit trail records requires two Administrator user names and passwords.
The “Remove Sample Archives” specifies that a user can archive and remove 1154
project/sample records in binary or text format.
The “View Audit Trails” privilege allows a user to view the System Audit Trail, 1154

which tracks changes to system-related information.

The “Archive System Audit Trails” privilege specifies that a user can archive the
System Audit Trail in binary or text format. The user can not remove the System
1154 3
Audit Trail.
The “Clear/Restore Offline Audit Trails” privilege specifies that a user can remove 1154
and/or restore archived System Audit Trail records from a binary file format.
Records cannot be restored from a text file format.
The “Clear/Restore Offline Archives” privilege specifies that a user can remove 1154
and/or restore all entries from the offline project and sample archives.
The “Restore Archives” privilege specifies that a user can restore projects that have 1154
been backed up using the AutoArchive utility.
The “Paste Shallow Copies” privilege specifies that a user can paste shallow copied 1154
fields. Shallow pasted files contain only the current version of a method. A full
audit trail project does not accept a shallow copied file unless the user has this
privilege and the system policy “Don’t Allow User to Copy from Non-FAT
Projects into FAT Projects” is turned off.
The “Lock Channels” and “Unlock Channels” privileges specify that a user can 1154
lock data channels, and/or unlock data channels, in the Project window.
The “Alter Custom Fields”, “Create Custom Field” and “Delete Custom Field” 1154
privileges specify that a user can modify, create and/or delete a custom field in the
Empower database.
The “Alter Default Strings”, “Create Default Strings” and “Delete Default Strings” 1154
privileges specify that a user can modify, create, and/or delete default strings in the
Empower database.
The “Alter Plate Type”, “Create Plate Type” and “Delete Plate Type” privileges 1154
specify that a user can modify, create, and/or delete plate types in the Empower
database.
The “Alter System Policies” privilege specifies that a user can alter system policies in 1154
the Empower database.
The “Alter Projects”, “Create Projects” and “Delete Projects” privileges allow a user to 1154
modify all properties (name, quota, access, custom fields, and so on) of a project, create
a project or delete a project from the Empower database.
The “Backup Projects” and “Restore Projects” privileges allow a user to archive and/or 1154
restore a previously archived project.
The “Change Project Owner” privilege specifies that a user can change the owner of a 1154
project in the Empower database.
The “Change Project Quota” privilege specifies that a user has a restricted form of 1154
the Alter Projects privilege, allowing the user to change only the database
tablespace quota of a project to which the user has access.
The “Create Project Path” privilege specifies whether the user has access to 1154
Manage Raw Data Files from the View menu of Configuration Manager. The user
with this privilege can create a new data path to store project information.
The “Change Project Path” privilege allows the user to specify a project path other 1154
than the default when modifying a project. The new data path is defined in the
Move Project Data dialog box.
The “Specify Project Path” privilege allows the user to specify a project path other 1154
than the default when creating a project. When the user creates a new project and
has this privilege, he can designate where the project data is stored by selecting the
path from a list box.
The “View Multiple Projects” privilege specifies that a user can open and view 1154
multiple projects in a single Project window.
The “Alter Users”, “Create Users” and “Delete Users” privileges specify that a user 1154
can change the properties of another user, create a new user or permanently remove
a user from the Empower database.
The “Alter User Type”, “Create User Type” and “Delete User Type” privileges 1154

specify that a user can change the properties (name and privileges) of a user type,
can define a new user type or can permanently remove a user type from the
Empower database.
3
The “Alter User Groups”, “Create User Groups” and “Delete User Groups” 1154
privileges specify that a user can change the members of a user group, create a new
user group or permanently remove a user group from the Empower database.
The “Delete Calibration Curves” and “Save Calibration Curves” privileges specify 1154
that a user can permanently remove from and/or save a calibration curve to the
Empower database.
The “Delete Data” privilege specifies that a user can permanently remove 1154
chromatographic data, such as injections, channels, and so on, from a project.
The “Export Data” and “Import Data” privileges specify that a user can export data 1154
to and/or import data from a folder or device in a specified format.
The “Delete Libraries” and “Save Libraries” privileges specify that a user can 1154
permanently remove and/or create and modify libraries in the Empower database.
The “Rename Libraries” privilege specifies whether the user can change the name 1154
of a PDA or MS library.
The “Delete Export Methods” and “Save Export Methods” privileges specify that a 1154
user can permanently remove and /or can save methods used to export data to
another application.
The “Delete Instrument Methods” and “Save Instrument Methods” privileges 1154
specify that a user can permanently remove and/or save instrument methods used
for data acquisition.
The “Delete Locked Methods” privilege specifies that a user can permanently 1154
remove from the Empower database any methods (locked or unlocked).
The “Lock Methods” privilege specifies that a user can lock any methods in the 1154
Empower database. Once you lock a method, you cannot unlock or modify it.
The “Delete Processing Methods” and “Save Processing Methods” privileges 1154
specify that a user can permanently remove and/or save processing methods used
for data reduction.
The “Delete Reporting Methods” and “Save Reporting Methods” privileges specify 1154
that a user can permanently remove and/or save report methods used to report or
preview results.
The “Modify Report Scaling Only” privilege specifies that the user has the ability 1154
to edit the Scaling tab for plots that are part of a method (including locked
methods) for printing or previewing.
The “Modify Default Report Methods” privilege specifies that the user has the 1154
ability to customize default report methods using the Edit > Manage Defaults menu
in the Report Publisher.
The “Modify Default Report Groups” privilege specifies that the user has the 1154
ability to customize default report groups using the Edit > Manage Defaults menu
in the Report Publisher.
The “Clear Read Only Methods” privilege specifies that a user can clear a method's 1154
read-only status while another user is editing the method.
The “Save Methods as Current” privilege specifies that a user can save an earlier 1154
version of a method as the current version.
The “Delete Sample Set Methods” and “Save Sample Set Methods” privileges 1154
specify that a user can permanently remove and/or save sample set methods used to
define how and when to acquire from each vial in a set of vials.
The “Delete Sample Set Method Templates” and “Save Sample Set Method 1154
Templates” privileges specify that a user can permanently remove and/or save
sample set method templates used to predefine specific sample set parameters that
you know will change relatively infrequently.
The “Delete Method Sets” and “Save Method Sets” privileges specify that a user 1154
can permanently remove and/or save method sets used to define a collection of

methods (instrument, processing, report, and/or export methods) and channels of

data that control data acquisition, processing, reporting, and data exporting.
The “Delete 3D After Processing” privilege specifies that a user can permanently 1154
3
remove the 3D data associated with a PDA or MS data channel.
The “Modify Integration Parameters” privilege allows the user to open existing 1154
processing methods and make changes to the integration parameters and integration
events in the Integration tab of the method.
The “Modify Component Parameters” privilege allows the user to open existing 1154
processing methods and make changes to the following component parameters:
• Component table Retention Time
• Retention Time Window
• RT Window %
• 7 CConst fields
• Component Values in the Default Amounts tab
• Start and End times of a peak group
• Slicing tab (GPC) Retention Time, RT Window and 7 CConst fields
• Calibration tab (GPC) Reference Peak Retention Time and RT Window
The “Copy To Projects” privilege specifies that a user can copy information from 1154
one project into another project.
The “Delete Results” and “Save Results” privileges specify that a user can 1154
permanently remove from and/or save results in the Empower 3 database.
The “Sign Off Results 1” and “Sign Off Results 2” privileges specify that a user 1154
can fill in the respective sign-off field in a result.
The “Specify Report Methods for Sign Off” privilege specifies that a user can indicate 1154
which report methods are required for signoff.
The “Alter Sample” privilege specifies that a user can change information about the 1154
contents of a vial after an injection from that vial has been made.
The “Save View Filters” privilege specifies that a user can save view filters created 1154
in the Project window.
The “Make View Filters Public” privilege specifies that a user can create or change 1154
the access type of a view filter to make it public or private.
The “Acquire Samples” privilege specifies that a user can acquire data from a 1154
sample set method in Run Samples.
The “Edit Sample Sets” privilege specifies that a user can modify existing sample 1154
set methods in Run Samples or in the Sample Set Method Editor.
The “Reinject Samples” privilege specifies that a user can reinject individual 1154
samples or sample set methods that have been previously acquired in Run Samples.
The “Allow Interactive Sys Changes” privilege specifies that a user can 1154
interactively change pump parameters in Run Samples.
The “Alter Running Sample Sets” privilege specifies that a user can modify a 1154
sample set method while it is being acquired in Run Samples.
The “Access Real time Plot from Open Access” privilege specifies that the user can 1154
access the Real Time Plot from Open Access.
The “Alter Any Queue” privilege specifies that a user can rearrange any jobs in the 1154
Sample Sets table queue in Run Samples.
The “Alter My Queue” privilege specifies that a user can rearrange his/her jobs in 1154
the Sample Sets table queue in Run Samples.
The “Warn on Service Limit” privilege specifies that, if a user tries to use Run 1154
Samples when an instrument in the chromatographic system is past its service date
limit, the user is warned but allowed to continue. In this case, a user without this
privilege cannot acquire data in Run Samples.
The “Use Wizard Templates” privilege specifies that a user can create a sample set 1154
method from a sample set method template (which you create using the Sample Set
Method wizard).

The “Allow Remote LAC/E Reboot” privilege specifies that the user can remotely 1154
reboot a LAC/E32 Module from Configuration Manager.
Allow shallow copy of methods between Full Audit Trail projects (Management 2154
3
tab)
Allow Custom Fields to be locked and unlocked (Management tab) 2154
Create Projects at the Root for Project Hierarchy (Management tab) 2154
Change Project Parent for Project Hierarchy (Management tab) 2154
Run Empower AQT (Management tab) 2154
Alter customized time zone list (Management tab) 2154
Restrict viewing of the following columns in Review = Area, %Area, Height, % 2154
Height, Amount, % Amount, Response, and Concentration
Restrict access to Calibrate and Quantitate functions 2154
The "Modify Report Scaling Only" privilege is modified as follows: 2154
• In a full audit trail (FAT) project, the user will be able to print (or save to
PDF, e-mail, or file) with a modified method, if the only change to the
method is to modify the report method scaling and the user has the Modify
Report Scaling Only privilege.
• In a FAT project, if the user does not have the Save Reporting Methods
privilege, the user will not be able to modify any aspect of the method.
• In a FAT project, if the user has the Modify Report Scaling Only privilege
and modifies the report scaling, then they will be prompted for a user
comment and the changes will be documented as an audit trail on affected
plot(s).
Save Results and Calibrations in Review (Methods Tab) (Review Manual Result 2154
Saving)
View Quantitation Peak Fields in Review (Management tab) allows control over 2154
viewing the following fields in Review:
• Area,
• % Area,
• Height,
• % Height,
• Amount,
• % Amount,
• Response
• Concentration
Allow Calibration and Quantitation in Review (Management tab) allows users to 2154
calibrate or quantitate in Review or QuickStart. The following items in the Process
and Edit menus and their associated toolbar buttons are always disabled when the
user does not have this privilege:
• Process, Calibrate
• Process, Quantitate
• Process, Quantitate Standard
• Process, Manually Identify Peaks (non-GPC only)
• Process, Calculate Curve
• Edit, Clear calibration
• Edit Manual Coefficients (GPC only)
Save Results and Calibrations in Review (Methods tab) 2154
Modify Report Scaling Only (Methods tab) 2154
Modify Component Constants/Default Amounts (Methods tab) allows users 2154
without the “Save Processing Method” privilege to open existing methods, modify
the following component fields in the Processing Method Editor or Review, and
save (or save as) the method:
• Component tab: In the Component table, the 7 CConst fields
• Default Amount tab: In the Default Amount table, the component values

• Slicing tab (GPC): In the table, the 7 CConst fields

Modify Component Times (Methods tab) allows users without the “Save
Processing Method” privilege to open existing methods, modify the following
3
component times in the Processing Method Editor or Review, and save (or save as)
the method:
• Component tab In the Component table, the Retention Time (non-Group
components) and RT Window (non-Group components) and the RT
Window (%) Time Group tab: Start and end times
• Slicing tab (GPC): Retention time and RT Window
• Calibration tab (GPC): Reference Peak Retention Time and RT window
Verify Incomplete Raw Data Files (Data Acquisition tab) allows a privileged user 2154
to determine if such a data file can be used.
View Quantitation Peak Fields in Review (Management tab). Show the following 2154
columns in Review: Area, % Area, Height, % Height, Amount, % Amount,
Response, and Concentration from others view. This privilege prevents manual
integration of peak areas for quantitation and allows only batch processing.
Allow Calibration and Quantitation in Review (Management tab). Calibrate and 2154
quantitate data in Review or QuickStart. Without this privilege, users cannot
quantitate data. They cannot add, insert, delete or modify points on the Calibration
Curve individual point table, or delete points on the Calibration Curve plot.
Modify Report Scaling Only (Method tab). Edit the Scaling tab for plots, and then 2154
preview/print the report from Report Publisher. The scaling change displays in the
report method and is recorded in the project audit trail.
Access Real Time Review from Run Samples (Data Acquisition tab). The 2154
privilege will be used to enable/disable the real time review button on the Run
Samples toolbar.
Delete Tune Methods and Save Tune Methods (Methods tab) 2154
Delete MS Calibration Methods and Save MS Calibration Methods privileges 2154
(Methods tab)
The “Validation Administrator” privilege enables All method validation privileges 2154 FR3
and the lock method privilege. These privileges are automatically turned on and
cannot be turned off. The Validation Administrator can also perform these tasks:
• Disapprove approvals in a validation study (validation protocol methods,
sample set methods, sample sets, and validation studies), even though the
data were originally approved by another user.
• Remove signed-off chromatographic results and validation results in a
validation study.
The “Alter Project Type” privilege specifies that after a project is created, a user 2154 FR3
can change the project type (standard, validation working, validation template).
The “Delete Validation Protocol Methods” privilege specifies that a user can delete 2154 FR3
a validation protocol method from the database.
The “Save Validation Protocol Methods” privilege specifies that a user can Save a 2154 FR3
validation protocol method in the database.
The “Delete Validation Studies” privilege specifies that a user can delete a 2154 FR3
validation study and all associated validation results from the database.
The “Save Validation Studies” privilege specifies that a user can Create a new 2154 FR3
validation study, attach sample set methods, sample sets, and result sets to a
validation study, and create validation results.
The “Clear Read Only Validation Studies” privilege specifies that a user can Clear 2154 FR3
a validation study's read-only status while another user edits the study.
The “Approve Validation Protocol Methods” privilege specifies that a user can 2154 FR3
Approve validation protocol methods that require approval.
The “Approve Validation Study Data” privilege specifies that a user can Within a 2154 FR5
validation study, approve sample set methods, sample sets, and validation studies.
The “Override Validation Data Checks” privilege specifies that a user can Override 2154 FR3

a red X (fail) status for sample set methods, sample sets, result sets, or validation
results within a validation study.
The “Save Named Table Preferences” privilege specifies that a user can save 2154 FR5
3
named table preferences to the database.
The “Delete Named Table Preferences” privilege specifies that a user can delete 2154 FR5
named table preferences from the database.
The “Manage Process Only Sample Sets” privilege specifies that a user can create Empower
Process Only Sample Sets. In order to delete Process Only Sample sets, a user must 3
have both the Delete Data and Manage Process Sample Set privileges.
The “Delete eCord Columns” privilege specifies that a user can delete eCord Empower
column information from the Empower database. 3
The “View Message Center for All Users” privilege allows users to see messages Empower
in the Message Center for all users, or only messages of their own. 3
System Policies
System policies control the behavior of Empower 3 and how users interact with it. You can set
rules governing user accounts, log in procedures, full audit trail default settings, data processing
techniques, results signoff, date formats, and electronic records and signatures. System policies
apply to all users accessing the system.
If you work in a regulated environment, System Administrators can follow your SOPs to select
the recommended settings for GXP to comply with FDA Rule 21 CFR Part 11. If you work in an
environment which does not require compliance with 21 CFR Part 11, you do not have to choose
the GXP settings.
Function Build
User Account Tab – Available policies include: Various
• Authentication: Local Authentication or LDAP Authentication
Authentication
• (GXP) Enforce Unique User Account Names
• (GXP) Enforce Unique User Passwords(GXP) Password Expires every n
days
• (GXP) Limit # of Entry Attempts to n tries
• (GXP) Enforce Minimum Password Length of n characters
• Don't allow applications to stay running after logging off
• Don't allow multiple logons
• Global Default User Interface
New Project Policies – Available policies include: Various
• (GXP/ER/ES) Full Audit Trail Support
• (GXP) Don't Allow User to Change Default Full Audit Trail Support
Setting
• (GXP) Don't Allow User to Change Default 'Require User Comments On'
Settings
• (GXP) Don’t Allow User to Copy from non-FAT Projects into FAT
Projects
• Allow shallow copies between FAT projects
System Audit Trail Policies – Empower automatically generates secure and time- Various
stamped audit trails that track any user who performs system-level activities
identified as system objects in this tab. You can specify whether users must enter a
comment and/or their Empower password whenever they create, modify, or delete
one of these system objects. Comments can be set to silent, restricted or
unrestricted. Restricted comments are defined through the use of default strings.

Data Processing Policies – Available policies include: Various

• Use 3.0X Style Peak Width and Threshold Determination
• Use v2.XX Style Retention Time Calculations
3
• Prompt User to Save manual changes
• Calculate % Deviation of Point from Curve
• Enable Empower (1154) ApexTrack Manual Integration
Other Policies – Available policies include: Various
• Applications Timeout after x minutes
• Disallow Use of Annotation Tools
• (GXP/ER/ES) Time Zone Format
• Advanced Database Performance
Result Signoff Policies -- Available policies include: Various
• (ES) Sign Off Inactivity Delay
• (ES) Clear password after sign off
• (ES) Enforce Single Logon for Sign Off
• (GXP) Allow 'Lock Channels' after Sign Off 2
• (GXP) Save report image (as PDF) after Sign Off
• Require Sign Off 1 and Sign Off 2 by Different Users
• (GXP) Multiple signoff behavior
• (GXP) Enforce Sign Off 1 before Sign Off 2
Use LDAP UPN (User Principal Name) can be used to uniquely identify users. Empower
3
Empower LDAP Authentication will work with more than one domain. Empower
3

Plates
A plate type defines the physical and referential characteristics of a sample plate used for
3
injections by an instrument such as a Waters 2790 Separations Module. A plate contains wells
that hold the samples for injection. The plate type is the definition of both the overall plate and
the wells contained within them. The terms plate and well can also be defined as rack and bottle,
carousel and vial, and so on.
Function Build
Plate types can be created, modified and saved to the database. 1154
Plate configuration property sheets graphically display what the plate of a specified 1154
type looks like and will show the effects of any parameter changes immediately.
Users can not modify or delete the predefined plates in Configuration Manager. 1154
Plate definitions can be exported to a text file. 1154
Plate definitions can be imported from a text file. 2154 FR5
Libraries
A library is a user-created or commercial collection of PDA and/or MS spectral data collected

from known compounds. By comparing spectra from unknown peaks to library spectra, you may
be able to identify the unknown components.
Function Build
The software supports integrated MS searching for the Wiley or Wiley and NIST 1154
libraries.
Libraries can be archived and restored. 1154
Libraries may be imported and exported. Importing a library will allow the spectra 1154
in the import library to be merged into an existing library.
Spectra may be merged with a specified spectrum library. 1154
Support for the Wiley or Wiley and NIST libraries is discontinued. 2154
Message Center
The Message Center is a run time log that stores temporary, system-level messages. The Message
Center displays informational, warning, error, and fatal messages related to Empower 3 system
operation.
Function Build
The Message Center is located in the Microsoft Windows System Tray. 1154
The Message Center icon appears in red when there are messages present that have 1154
not been viewed. Normally, the icon appears in blue.
Messages may be saved to a file for archival and transmission. 1154
The purge capability of the Message Center may be password protected. 1154
The Message Center may be refreshed manually to ensure that new messages are 1154
displayed.
The Message Center Window displays information in a tabbed table using the 1154
following sections:
• All
• General
• Acquisition
• Security
• Processing

The Message Center may be purged to minimize storage required. 1154

Sections of the Message Center may be purged individually.
The Message Center can be purged automatically after a user specified number of
1154
1154
3
days.
The Message Center may be forced on top of other windows if an error has 1154
occurred and the users needs to be notified.
The Message Center displays informational, warning, error, and fatal messages 1154
related to Empower 3 system operation.
Messages are displayed in order of date and time. 1154
New messages are added to the bottom of the list. 1154
Email Messages from the Message Center: 2154
> Specify category and type of messages to e-mail
> Configure single client as mail server
Message Center: Settings will be centrally stored. 2154
System Monitor
The System Monitor application allows you to monitor system database usage in real time.
Information on users, projects, systems, and processing servers is displayed in table form.
Function Build
The System Monitor application allows you to monitor system database usage in 1154
real time. Information on users, projects, systems, and processing servers is
displayed in table form.
The number of licensed users and the number of currently logged in users are 1154
shown.
The user may choose to show only objects in use or to show all objects defined in 1154
the database (users, systems, projects or processing servers).
The frequency of display update can be set by the user 1154
The User view will display the following information: 1154
• User name
• Computers that the user is currently logged in to (if any)
• Projects the user currently has open (if any)
• Systems the user is currently acquiring data from (if any)
The System view will display the following information: 1154
• System name
• Computer that is currently running the system
• User for whom data is being acquired (if any)
• Project into which data is being acquired (if any)
• Current activity of the system
• Names of any other users who are viewing the system
The Project view displays the following information: 1154
• Name of the project
• Users who are currently using the project (if any)
• Systems that are acquiring data into the project (if any)
• Available free space and allocated space for the project
The Processing view will display the following information: 1154
• Name of the computer running the processing server
• User who is running the processing server (if any)
• Name of the project for which data is being processed
• Status of the processing server

Installation
Function Build
3
Named user license key disks will be used during installation to define the 1154
maximum number of users configured in the database.
An installation of the server can be either automatic or custom. 1154
The user will be allowed to choose which, if any, acquisition device drivers are 1154
loaded.
Named user license key disks are available in different capacities to facilitate ease 1154
of installation and incremental removal of licenses.
Migration from the previous version of Millennium32 software will allow for the 1154
database to be migrated to the new version.
Option disks for Enterprise and Workgroup installations will activate the specified 1154
option for all users of the database.
Empower uses the industry-standard InstallShield software to perform software 1154
installation.
Options key disks will be used during installation to define which optional 1154
Empower components should be activated on the system (e.g. System suitability,
Dissolution etc.).
Option and license key disks may be uninstalled. 1154
The following software options are available: 1154
• System Suitability
• PDA (this option is built in and does not require a key disk)
• MS (this option is built in and does not require a key disk)
• GPC
• GPC/V
• GPC/V/Light Scattering
• Dissolution
• Pattern Matching
• Open Access (this option is built in and does not require a key disk)
• Toolkit (Empower SDK programming user interface)
• Chemical Structures
• Agilent 1100
• Agilent GC
• AutoArchive
• WebServer
A data upgrade path is available between applications versions. 1154
Installation may be split across multiple disk drives. 1154
System license key disks will be used during the installation to define the 2154
maximum number of systems configured for each acquisition server.
Software options (i.e. System Suitability, Chemical Structures) allows users to 2154
enter the option serial number during the option install process.
Enterprise Data Manager option available 2154
Method Validation Manager option available 2154 FR3
Push installation for Empower clients and LAC/E32 Modules available 2154 FR3
Optional electronic license registration 2154 FR5
Key disks are discontinued; electronic license registration is required Empower
3
GPC, GPC/V and GPC/V/Light Scattering combined into the GPC/SEC option Empower
3
Pattern Matching option discontinued Empower
3
WebServer option discontinued due to the availability of remote access Empower

applications 3
Push installation for Empower clients, LAC/E32 Modules, and Instrument Control
Software available.
Empower
3
3
Custom Fields
Empower 3 software allows you to create your own custom fields of which there are two types:
• Custom Sample identifiers

• Custom Database results
Custom Sample Identifiers (Sample and Sample Set Type custom Fields)
Custom sample identifiers to describe an acquired sample beyond what is provided by the
Empower 3 software default identifiers (such as, SampleName, SampleWeight, Dilution, Lot
Number, Manufacturing Site and so on).
For example, you may want to identify samples with respect to lot number, dissolution medium,
storage interval, storage conditions, plant number, manufacture date, supplier, and so on. You
can associate such information with your samples by using custom sample identifiers.
Custom Database Results (Peak, Result, Component and Distribution Type, calculated custom
fields)
Custom database results to calculate a specific database result that is not already provided by
Empower 3 software.
For example, you may want to calculate the ratio of two peaks’ areas or determine the total area
of all peaks with a percent Area less than 2% or convert the amounts reported in Empower 3 to
different units.
Function Build
The following parameters are defined when creating a custom field: 1154
Name
Type (Integer, Real, Text, Date, Boolean or Enumerated)
Field Type (Sample, Peak, Result, Sample Set, Component, Distribution)
Width (the number of characters to be displayed)
Precision (the number of characters to be printed to the right of the decimal point
for real numbers)
Minimum (For keyboard-entered fields, displays the minimum value allowed)
Maximum (For keyboard-entered fields, displays the maximum value allowed)
Default (Automatically displays the user-defined default value)
Source (Keyboard, Calculated or External)
Required (Defines whether or not a user must enter information into this field
prior to acquiring the sample)
Formula (The user-defined mathematical calculation to take place when the
sample is processed)
Search Order (Used to define where the software should find results that are
references by an inter sample custom field: Result Set First, Result Set Only,
Outside First, Outside Only)
All or Nothing (Allows you to specify not to perform the calculation unless all
values referenced in the formula are found)
Use As (Used to define how the field’s result is interpreted when using a Boolean
or enumerated custom field: Position, Text, Value)
Cfield ID (The unique number that the software assigns to a custom field)
Once created, custom sample identifiers appear wherever samples are listed, such 1154

as in the:
• Injections, Channels, Peaks, Results, Peaks, and Custom Fields views in
the Project window
3
• Samples table in Run Samples
• Alter Sample table in the Alter Sample window
• Sample Set information in the Alter Sample window
• Sample Set table in the Sample Set Method Editor
• 2D Channels table and the 3D Channels table in Review
• Chromatogram Result table in the Results window of Review
• Reports
Once created, Custom database results are stored in the Empower 3 software 1154
database and appear in:
• The Peaks table in the Results window of Review
• The Chromatogram Result table in the Results window
• The Results, Peaks, and Custom Fields view in the Project window
• Reports
• Alter Sample table in the Alter Sample window
• Component Editor in the Alter Sample window
Sample Set type custom fields are available. 1154
Component type custom fields are available. 1154
Inter sample summary type custom fields are available. 1154
Boolean and enumerated fields are available. These fields allow you to create a 1154
sample type custom field that appears as a drop-down list or to create a peak or
result type custom calculated field that assigns a user defined translation to a
defined mathematical formula. For example, you could assign a particular criteria
to the Amount field and specify for the Empower 3 software to report “Pass” or
‘Fail’ for the custom field.
Inter-Sample calculations are available. 1154
There are no limitations on the number or size of custom fields. 1154
Custom fields may be created or modified without having to exit Empower. 1154
The user is given the choice to create the field in just the currently selected project, 1154
or to create it in multiple projects the user has access to.
It is possible to copy custom fields between projects. 1154
It is possible to calibrate on a custom field by specifying the field in the Y Value 1154
column of the component tab of the processing method.
Component references are available, CCalRef1 and CCompRef1–3 and Cconst1 – 7 1154
Custom fields can be nested together. For example, a custom field can incorporate 1154
another custom field in its formula.
The following special values can be used in custom fields to translate into the 1154
associated strings:
-60,000 translates to ND
-60,001 translates to N.D.
-60,002 translates to Not Detected
A value of –50,000 translates to a result of zero. 1154
Enumerated field can be translated into user entered value or as actual field value 2154
(such as Amount, Area or another custom field)
Calibration curve fields available for use in formula calculations 2154
Program custom fields to only calculate on a specific Sample Type (All, Standards 2154
only, Unknowns only, Standards and Unknowns, Standards and Controls,
Unknowns and Controls) and a Peak Type (Founds only, Unknowns only, Groups
only, Founds and Groups, Unknowns and Groups).
Allow user to enter value in Run Samples or Alter Sample for enumerated custom 2154
fields
Custom fields can be locked. 2154

System Suitability limit checks can be used with summary custom fields (for 2154
example, %RSD).
The Relative Response field is available for use in custom fields. 2154
3
Dissolution fields are available for use in custom fields. 2154
Summary custom fields are available. 2154
Login Dialog Box
Function Build
Login occurs to the default interface defined for each user. Multiple user interfaces 1154
(Pro, QuickStart, Open Access, Web, System Default) are available through the
Advanced >> button.
Raw Data Security

The Waters Service provides security controlled access to raw data files in an Enterprise or
Workgroup system.
Function Build
By default, chromatographic raw data is stored in the rawdata-drive:\Empower 1154
\Projects\ directory on the Empower server. However, you may change the location
of raw data using the Manage Raw Data Files capability.
A Windows Operating System service is available to provide security controlled 1154
access to raw data files in a client server system.
The Waters Service will be installed by the Empower installer such that it starts 1154
automatically when the operating system starts up.
The Waters Service will be run using the local System account on the server and 1154
the client.
Read-only access is the only required access to the raw data files for all Windows 1154
user accounts
Database Security
Function Build
User types determine access privileges for an Empower software user. When you 1154
create a new user account, you grant access privileges to the new user by assigning
a user type to that user. User types are completely customizable, and there is no
limit to the number of user types you can create. The default user types are:
Administrator (unlimited access), Chemist, Analyst, and Guest (read-only access).
A login password prevents unauthorized users from logging in to Empower 1154
software. You assign a login password when you create a new user account.
The Acquisition server security scheme (via user access and privileges) prevents 1154
unauthorized users from configuring or altering an acquisition server and the
systems connected to it.
The Chromatographic system security scheme (via user access and privileges) 1154
prevents unauthorized users from modifying a system or using it acquire data.
A Message Center Properties Password prevents unauthorized users from changing 1154
the Message Center properties, including purging messages from the Security log
and other logs.
System Policies allow you to set rules that govern passwords, logging in to 1154

Empower software, Full Audit Trail default settings, data processing, signing off
results, date formats, and setting up Empower software for GMP, electronic
records, and electronic signatures
3

Network Support 3
Client/Server Network Support
The Empower 3 Enterprise system is a corporate-wide networked version of the Empower 3
Personal workstation which operates on a Windows 7 or a Windows XP platform. The Enterprise
platform can also operate in a Citrix (thin client) environment.
General
Function Build
The software will support the Windows 2000 Server operating system on the 1154
database server.
The application will function in an Oracle Names environment. 1154
During login, if the name of a database is entered that is unknown to the 1154
application, and that name can be resolved by Oracle Names, Empower will
record that database name and make it available for subsequent logins.
Contains a central password-protected database located on an Intel server. 1154
Operates in a true multi-user Client/Server environment. 1154
Supports multiple computer clients running the Empower software application. 1154
Allows computer clients to access and use data, methods, and results residing in 1154
the server database.
Permits computer clients to control and acquire data from chromatographic 1154
systems:
Locally, through a Waters busLAC/E card or Equinox serial card installed in the
client computer or through the COM port of the client computer
Over the network, through the Waters LAC/E32 Module.
Permits control and data acquisition from chromatographic systems via Ethernet 1154 ISSP
The acquisition of sample sets or trays will continue during a server shutdown or 1154
remote network failure. Empower buffers data acquired from a single injection
or sample set on the acquisition computer hard disk or the Waters LAC/E32
Module.
When an acquisition server is able to reconnect with the server, it will 1154
automatically upload all buffered data files and then delete the local copy.
Uses standard Ethernet connections. 1154
Supports multiple network printers. 1154
Provides full database and raw data backup and restore functions from the server. 1154
Allows users to access raw data only through the Empower software application, 1154
which provides user-level security.
The software supports Windows Server 2003 R2, Enterprise edition, 32-bit 2154
operating system on the database server.
The software supports Sun Solaris 10 64-bit operating system on the database 2154 FR1
server.
The software supports Windows Server 2003 R2, Enterprise edition, 64-bit 2154 FR5
operating system on the database server.
The software supports Windows Server 2008 R2, Enterprise edition, 64-bit Empower
operating system on the database server. 3

Regulatory Compliance 3
Audit Trails
Audit Trails allow you to maintain a permanent record of changes made to methods, results,
and/or samples for a project. You specify Audit Trail parameters when you create a new project
using the New Project wizard in Configuration Manager. A System Audit Trail is also available
for activities that are not Project related.
General
Function Build
When information is copied/backed up, the audit trail information is copied along 1154
with the object.
Audit trail support is implemented for the entire system (database), samples, 1154
methods and injections.
Audit trails for samples, methods and injections can be viewed separately or 1154
combined in the Project audit trail.
An Audit Trail application is provided to give access to and search capabilities 1154
for the System and Project Audit Trails.
Audit Trails can be filtered and sorted according to user defined criteria. 1154
Audit Trail filtering and sorting criteria can be saved for later reuse. 1154
Audit trails cannot be bypassed once activated. 1154
Audit trail entries may not be deleted or modified once created. 1154
Audit trails can be printed. 1154
System Audit Trails

Function Build
Two administrative users are required to enter their passwords when purging the 1154
System Audit Trail.
Audit trails can be saved to a binary or ASCII file for archival and/or 1154
transmission.
Audit trails can be purged to reduce the space allocated on disk. 1154
Audit trails can only be purged if two individuals with administrator level 1154
privileges enter their user name and passwords to allow the purge operation to
complete.
Unsuccessful login attempts will be audited in the System Audit Trail. 1154
Account lockouts will be audited in the System Audit Trail and also brought to 1154
the system administrator’s attention through the Message Center application.
Allow for Silent, Restricted or Unrestricted Comments on changes system 2154
objects
Re-authentication on changes to system objects 2154
Database ID included in entries 2154
Project Audit Trails

Function Build
Project Audit Trail information cannot be purged. 1154
The Method audit trail is stored with the methods and moves with the methods if 1154
they are copied between projects.
The Injection audit trail is stored with the injections and moves with the 1154

injections if they are copied between projects.

The Sample audit trail is stored with the samples and moves with the samples if
they are copied between projects.
1154 3
Project audit trails must be activated when a project is created. 1154
Audit trails may not be deactivated or turned on after a Project is created. 1154
Project audit trails will audit the creation, modification and deletion of project 1154
objects.
Project audit trails can be activated without the requirement for comments to be 1154
entered when any objects are changed.
Project audit trails can be configured to require comments for Method changes, 1154
Result changes or Sample Information changes or any combination of these
items.
Allow for Silent, Restricted or Unrestricted Comments on changes to project 2154
objects including:
• result changes made in Review
• results produced via background processing
• samples and results produced in Run Samples or QuickStart
• samples altered via Alter Sample
Re-authentication can be required on changes to project objects 2154
Database ID included in entries 2154
The project audit trail audits when a user requests an abort while running a 2154
sample set in an audit trailed project.
The project audit trail audits when the user submits an altered sample set (as a 2154
result of Alter Running Sample) in an audit trailed project.
System Policies
The System Policies section of the Empower 3 application controls the behavior of several aspects
of Empower 3 software. These settings are not user or project specific and will affect all users of
the Empower 3 system. By recommending configuration settings, the Empower 3 software ensures
that electronic records and electronic signatures compliance is implemented easily. Selecting the
appropriate choices configures the Empower 3 software to comply with 21 CFR Part 11. The
parameters recommended for electronic records compliance are also recommended for laboratories
operating under GMP, GLP, GAMP, GALP, ISO 9000, or other guidelines.
User Account Policies

These policies control how a user logs into the Empower 3 application and what happens when
they log out.
Function Build
The “Enforce Unique User Account Names” policy is required for electronic 1154
signature compliance. This policy specifies that all user account names in the
current database must be different from one another; when you create a new
user account, the user account name must be new. Additionally, you are not
allowed to delete a user account from the database; user accounts will be
removed instead. (This ensures that you cannot reuse a username from a
previous account.)
The “Enforce Unique User Passwords” policy is required for electronic 1154
signature compliance. This policy specifies that a single user account cannot
reuse an old password in the Empower database. If your password expires, you
must enter a new password that you have not used before.
The “Passwords Expire Every n Days” policy is required for electronic record 1154

and electronic signature compliance. This policy specifies that all user account
passwords expire at the end of the interval (days) you determine. When
passwords exceed the specified number of days, users receive a message
3
requesting a password change. Users are not allowed to log in again until they
change their passwords.
The “Limit # of Entry Attempts to n Tries” policy is required for electronic 1154
record and electronic signature compliance. This policy specifies that all users
have a limited number of chances to log in successfully to the Empower 3
database or attempts into the result signoff function in Preview in Report
Publisher. On the n+1 attempt, the software denies the user access to Empower
software and disables the user account. In this case, the system administrator
must restore the account status to Active.
The “Enforce Minimum Password Length of n Characters” policy is required 1154
for electronic record and electronic signature compliance. This policy specifies
that all user accounts must have passwords and that all passwords must have the
minimum number of characters that you specify in the text box.
The “Don't Allow Applications to Stay Running After Logging Off” policy 1154
specifies that your only option is to lock all applications that are still running
when you log out of Empower.
The “Don't Allow Multiple Logons” policy specifies that only one user can log 1154
in at a time.
The “Global Default User Interface” policy specifies the default user interface 1154
when the user logs in to Empower: Pro, QuickStart, or Open Access. You
cannot specify Empower Web as the default user interface. The user’s profile
overrides this default interface.
Network Authentication via Active Directory (LDAP) capability allows 2154 FR5
authentication to be provided by an Active Directory server for events that
require authentication (login, sign off, documenting changes, etc.)
An existing User account can be associated with an LDAP account 2154 FR5
A new User account can be created with an association to an LDAP account 2154 FR5
A User account can be designated as “always local” 2154 FR5
LDAP user accounts can be found by searching 2154 FR5
Multiple Domain Managers can be defined for LDAP authentication 2154 SP G
LDAP groups are supported 2154 SP G
LDAP accounts are identified by User Principle Name (UPN) 2154 SP G
New Project Policies

These policies control how the Empower 3 audit trail facilities will be applied and enforced.
Function Build
The “Full Audit Trail Support” policy is required for electronic record and 1154
electronic signature compliance. This policy specifies that the Full Audit Trail
feature be turned on in all new projects.
The “Require User Comments On Method Changes” policy is required for 1154
electronic record and electronic signature compliance. This policy specifies that
you must enter comments that describe any changes you make to a method (for
example, a processing method).
The “Require User Comments On Result Changes” policy is required for 1154
electronic record and electronic signature compliance. This policy specifies that
you must enter comments that describe any changes you make to a result in
Review.
The “Require User Comments On Sample Information Changes” policy is 1154
required for electronic record and electronic signature compliance. This policy
specifies that you must enter comments that describe any changes you make to

sample information.
The “Require User Comments On Deletion” policy specifies that you must enter
comments that describe any deletions in Empower (e.g., delete methods,
1154 3
channels, sample sets, method sets, processing methods, instrument methods,
etc.).
The “Don't Allow User to Change Default Full Audit Trail Support Setting” 1154
policy is required for electronic record and electronic signature compliance. This
policy specifies that the default state of Full Audit Trail Support cannot be
changed when creating a new Project.
The “Don't Allow User to Change Default 'Require User Comments On' 1154
Settings” policy is required for electronic record and electronic signature
compliance. This policy specifies that the requirements for user comments
cannot be changed when creating a new Project.
The “Don’t Allow User to Copy from non-FAT Projects into FAT Projects” 1154
specifies that a user cannot copy data from a non-Full Audit Trail Project into a
Full Audit Trail Project.
The “Allow the use of ApexTrack Integration” specifies that the possibility of 1154
using the ApexTrack integration algorithm is enabled. (Additional settings are
still needed to enable ApexTrack on a project level and on a processing method
level.)
The “Enable ApexTrack Integration” setting in the Default Settings Used When 1154
Creating New Projects area specifies that new projects have ApexTrack
integration enabled by default. Note that existing projects do not have
ApexTrack automatically enabled. Additionally, ApexTrack can be
enabled/disabled through the project properties dialog box.
The “Default Integration Algorithm” setting specifies whether new processing 1154
methods are set to ApexTrack or to Traditional by default.
To specify that users enter comments and/or their password: 2154
In the Default Audit Trails table, click the Comment column for the Method,
Result, Sample, or Deletion row, and then select one of the following choices:
• Silent; users do not have to enter a comment
• Restricted; users must choose a default comment
• Unrestricted; users must choose a default comment or enter a free form
comment
To specify that users enter their password, select the Confirm Identity checkbox. 2154
Shallow copy of methods allowed between Full Audit Trail projects 2154
System Audit Trail Policies

These policies control how the Empower 3 audit trail facilities will be applied and enforced.
Function Build
Empower automatically generates secure and time-stamped audit trails that track 2154
any user who performs system-level activities identified as system objects on this
tab. You can specify whether users must enter a comment and/or their Empower
password whenever they create, modify, or delete one of these system objects.
In the System Audit Trail table, click the Comment column for the Method,
Result, Sample, or Deletion row, and then select one of the following choices:
• Silent; users do not have to enter a comment
• Restricted; users must choose a default comment
• Unrestricted; users must choose a default comment or enter a free form
comment
To specify that users enter their password, select the Confirm Identity checkbox. 2154

Other Policies
These policies control how certain data processing and signoff functions operate.
3
Function Build
The “Use v3.0X Style Peak Width and Threshold Determination” policy 1154
specifies that Empower software use the peak width and threshold determination
method used in the Millennium32 version < 3.0x instead of implementing the
Auto-Peak Width and Auto Threshold capability. This can ensure consistent
integration behavior between versions of software.
The “Use v2.XX Style Retention Time Calculations” policy specifies that 1154
Empower software uses the Millennium32 version < 2.xx algorithm to determine
peak retention time and height. This can ensure consistent integration behavior
between versions.
The “Prompt User to Save Manual Changes Made in Review” policy specifies 1154
that the software display a message to remind you to save changes that you make
manually to a result or calibration in Review before exiting.
The “Calculate % Deviation of Point from Curve” policy specifies that Empower 1154
software use the percent deviation that is similar to Maxima CDS ((Actual
Amount minus Target Amount divided by Target Amount) multiplied by 100).
The “Sign-Off Inactivity Delay” policy is required for electronic signature 1154
compliance. This policy specifies that if you log in to sign off results, and you do
not sign off within n minutes, Empower software clears your password. You
must reenter your password to continue signing off results.
The “Clear Password After Sign-Off” policy is required for electronic signature 1154
compliance. This policy specifies that the software clear your password after
performing a single signoff operation. This forces you to reenter your password
to perform each subsequent signoff operation.
The “Enforce Single Logon for Sign-Off” policy is required for electronic 1154
signature compliance. This policy specifies that, if you are also logged in to
another Empower client, the software does not process the signoff operation.
The “Allow 'Lock Channels' after Sign-Off 2” policy is required for electronic 1154
signature compliance. This policy specifies that the data channels associated with
results being signed off can be locked after signoff, preventing the data being
reprocessed and additional results being generated.
The “Save Report Image (as PDF) After Sign Off” specifies that when a report is 1154
signed off in Preview, the report is saved as a PDF file in the database and is
linked to the electronic signature.
The “Enforce Sign Off 1 Before Sign Off 2” specifies that a Level 1 sign off is 1154
required before a Level 2 sign off can be obtained. You must specify at least one
valid sign off reason for a Level 1 signature in the Valid Sign Off 1 Reason List:
Review, Approval, Responsibility, or Authorship (default values).
The “Use "Long" Date Formats” policy specifies that the software indicate the 1154
day of the week, the month, the date, and the year when displaying a date. This
ensures that dates are not regional and are displayed in an unambiguous way.
The “Require User Comments on Changes to System Objects” policy specifies 1154
that user comments are required whenever an object (for example: project, user,
user group, plate type, default string, etc.) is added, changed, or deleted in
Configuration Manager.
The “Applications Timeout after x minutes specifies that the Empower 1154
application will be locked if inactivity exceeds the length of time specified (in
minutes). When the system is inactive for more than the minutes specified, the
user must reenter his or her password to unlock the Empower application. (The
following applications do not support application timeout: Message Center,
Connections AQT, Processing Monitor, Pro Window when not logged on,
Restore DB, and Set Archive DB.)

A Multiple Sign Off System Policy for use if a user attempts to sign off a result 2154
more than once using the same reason code.
Require Sign Off 1 and Sign Off 2 by Different Users. The same user cannot 2154
3
perform sign off 1 and sign off 2 on the same result.
Disallow Use of Annotation Tools. Prevents users from using the annotation 2154
tools in Report Publisher. This ensures consistency among reports.
Time Zone Format. Whenever data is acquired/processed/reported, the time 2154
stamp will include the designated time zone. You can set universal time stamp
configurations, such as regional time zone names, abbreviations for time zones,
and whether you want to use the abbreviated or full region name when the time
zone information is displayed:
• Select how to display the region name: in its entirety or in an
abbreviated form
• Show Region Name displays the region name in its entirety, such as
Eastern
• Standard Time, instead of the abbreviation (EST)
• Show Region Abbreviation displays an abbreviated form of the region
name, such as EST, instead of Eastern Standard Time

Instrument Control
The Instrument Method Editor is the graphical interface in which you define the configuration and
3
setup of individual chromatographic instruments used to acquire data. Every instrument that can
be controlled by Empower 3 has a set of property pages used to define the instrument’s operating
parameters. These property pages are displayed and are editable in the instrument method editor.
General Functionality
Function Build
When using an Agilent 5890 or 6890 gas chromatograph, the installed syringe 1154
size and whether the nanoliter adapter for A and/or B towers is installed can be
specified. Syringe size checking can be disabled so that the syringe steps 1 – 5
will be used as in Empower software.
Support for “Column Position” of a 2695, 2690D, or 2695D (firmware version 1154
2.0 or higher) when a column switching valve is present. The Column Position
field is enabled for Condition Column and Equilibrate functions only.
Support for the Alliance Heater/Cooler. 1154
Control of the following Agilent 1100 Series instruments: 1154
• Isocratic Pump
• Binary Pumping System
• Quaternary Pumping System
• Thermostatted Column Compartment (TCC)
• Standard Autosampler
• Autosampler with Temperature Control
• Variable Wavelength (VWD) UV Detector
• Multiwavelength (MWD) UV Detector
• Diode-Array Detector (DAD) Detector (Ethernet required)
• Refractive Index Detector
• Fluorescence Detector (FLD)
• A1200 systems are supported on Ethernet
Only A1100 systems are supported on Equinox serial card without DAD; they
are supported on Ethernet with DAD or FLD.
The ZQ 2000/4000 mass detector is supported. 1154
The Waters’ 2414 refractive index detector is supported (in 2410 emulation 1154
mode).
The Waters’ 2996 photodiode array detector is supported (can be set up to 1154
acquire 8 discreet channels of data rather than 3D data).
The Waters’ 1515 and 1525 pumps are supported. 1154
Ability to print the results of PDA diagnostics. 1154
Ability to perform a wet prime when using the 2690/2695 or 2790/2795. 1154
A Skip Transfer check box is available to allow a 2690D dissolution sample set 1154
to be re-run without needing transfers.
A toolbar containing buttons corresponding to each of the instruments in the 1154
system is shown with the name of the instrument and a small diagram
representing it. This allows the user to switch the view to that of the selected
instrument.
Instruments may be turned ‘On’ and ‘Off’ and also may be ‘Added’ or ‘Deleted’ 1154
within the editor.
Dual Tower gas chromatograph (5890 and 6890 GC) control is supported as well 1154
as all common inlets and detectors supported by Agilent.
HP 7673 GC autosampler control is supported 1154

A plate editor is available to configure plates when using the 2790/2795 or other 1154
autosamplers. Samples can also be easily loaded into the sample loading table
using this editor.
3
The Waters Alliance Dissolution System (2690D) control is supported. 1154
The 474 Fluorescence detector control is supported. 1154
The Waters Capillary LC control is supported. 1154
busSAT/IN, 474 and 5890 and 7673 support is available through a serial card 1154
port or a PC COM port.
Control of the ACQUITY UPLC System components: 1154
• Sample Manager (ACQ-SM)
• Binary Solvent Manager (ACQ-BSM)
• Detector (ACQ-TUV)
• Detector (ACQ-2996)
• Sample Organizer (SO)
Control of the Agilent 6850 Gas Chromatographs 1154
ESCI Interface Control for ZQ and EMD1000 2154
The control of any current Waters’ instrumentation is supported and described in 2154
the Empower System Installation and Configuration Guide.
Pump instrument method editors have the defaults for the percentages of each 2154
pump logically change as the user enters percentages.
ACQUITY Column Manager support: If the ACQUITY Column Manager is part 2154 FR3
of the chromatographic system, then the position setting of the column selection
valve is now included on the Single Screen and on the Samples Screen in Run
Samples and in QuickStart. The Column sample set line field in the samples table
is enabled for data input when the ACQUITY Column Manager is part of the
system and the sample set line function is either Equilibrate or Condition
Column. The field, when editable, presents a combo box with the choices of ‘No
Change’, ‘1’, ‘2’, ‘3’, and ‘4’.
When using a 6890-series gas chromatograph (6890A, 6890 Plus, or 6890N), 2154 FR4
three tabs are available in the Instrument Method Editor:
• Valves – within the configurations allowed by Agilent, control for up to
8 valves installed in the 6890 GC
• Events – events to your 6890 instrument method, triggered by signal,
valve, or pressure channels
• Auxiliary – control parameters for up to two thermal channels and up to
three pressure channels, if installed
In the Column 1 and Column 2 tab of the Instrument Method editor, a new outlet
pressure mode selection box was added that lets you select from ambient,
pressure correct, or vacuum correct outlet pressure.
Additional GC control parameters for the 6890-series gas chromatograph 2154 FR5
(6890A, 6890 Plus, or 6890N).
ACQUITY UPLC eCord usage information is stored in the Empower 3 database Empower
(config manager and associated with injections). When you use an ACQUITY 3 (requires
system that contains a column with an eCord to perform an injection, the system updated
either updates the column usage information for an existing eCord, or adds a new Acquity
eCord entry and its column usage data to the Empower 3 database. ICS)
ACQUITY UPLC Sample Manager: In Full loop mode, the injection volume is Empower
limited to the volume of the installed loop. 3 (requires
updated
Acquity
ICS)
ACQUITY UPLC Sample Manager: In Partial loop with needle overfill mode, if Empower
you enter an injection volume outside of the recommended range, the software 3 (requires

displays a warning message, but allows you to make the injection. updated
Acquity
ICS)
3
ACQUITY UPLC Sample Manager: You can enter fixed vial positions in Run Empower
Samples. Fixed vials are vial locations that are built into the SM-FTN module. 3 (requires
They are not part of a sample plate. You can include fixed vial locations in updated
sample sets or use them for single injections. The Sample Manager uses four Acquity
fixed vials positions: V:1, V:2, V:3, and V:4. ICS)
ACQUITY UPLC Sample Manager Flow-Through Needle (SM-FTN) module: Empower
Empower supports the Auto-addition functionality. 3 (requires
updated
Acquity
ICS)
ACQUITY UPLC Sample Manager Flow-Through Needle (SM-FTN) module: Empower
Empower supports the Auto-addition functionality. 3 (requires
updated
Acquity
ICS)
ACQUITY UPLC: Column Selection choice in Run Samples reflects the Empower
number of configured columns. 3 (requires
updated
Acquity
ICS)
Waters Fraction Collector III (WFC) III: Empower stores the fraction data, in a Empower
fractions table, in the Empower 3 database. The software associates the fractions 3 (requires
data with the injection ID. Because fraction data is stored in the Empower 3 updated
database, you can use ICS and
Empower software to view data associated with injections. firmware)
• Fraction annotations available on chromatogram
• Fraction table present in Review
• Fraction tab present in Project window
Result Sign Off

An electronic signature process in which personnel who are assigned sign-off privilege by the
system administrator can review results in Preview and then sign off the displayed results.
Empower 3 software allows two levels of result sign off. Multiple signoffs on the same result are
allowed in Preview.
Function Build
When a result is signed off, the report used for sign off is saved as a PDF file and 1154
stored in the database, provided that the Save Report Image (as PDF) after Sign
Off” system policy is enabled.
Reports saved as a PDF after signoff can be retrieved at a later time to see the 1154
data exactly as it was when it was signed off using the Report Viewer.
An “Allow this Method to be used in Sign Off” check box is present to specify 1154
whether or not any given report can be used for sign off.
Two levels of results sign off are available (“Sign Off 1” and “Sign Off 2”) to 1154
allow different categories or levels of sign off privilege within the software.
Multiple signoffs are allowed within each sign off level. 1154
If the “Enforce Sign Off 1 Before Sign Off 2” system policy is enabled, the 1154
report publisher does not allow a sign off 2 until a sign off 1 with a valid sign off

reason has been performed.

Each sign off includes:
• The date and time the signoff occurred
1154 3
• The full, printed name of the signer
• The reason of the sign off
• The sign off ID
• The sign off method date
• The sign off method ID
• The sign off Method name
• The sign off method version
All of the pages of the current report must have been previewed before a sign off 1154
can be performed.
Sign off can be done on individual results or on groups of results, depending on 1154
the type of report used to preview the results.
Sign off inactivity delay is enforced. 1154
The first sign off during a session requires that two unique pieces of information 1154
be entered to identify the user (user name and password).
Subsequent sign off’s during the same session require only a single piece of 1154
identification to be entered (password).
A user can sign off results while one or more different users are logged into the 1154
application to perform other functions such as data acquisition or processing.
All review and approval is performed within the Empower application, with 1154
complete tracking of approval state.
The number of signings for each result will be stored with the result. 1154
When determining the reason for an electronic sign off, the user can type in a 1154
reason, or choose from a list of predefined reasons.
When a result has been signed-off using “Sign Off Level 2”, the result may be 1154
locked to prevent further results being saved based on the specified sample.
Pro Interface
The Pro Interface provides access to all features of the Empower 3 software. This interface is similar to
that of Millennium32 and will therefore be familiar to Millennium32 users.
Pro Window
Function Build
All activities in Empower are initiated from the Pro Window when using the Pro 1154
interface.
The Pro window works like a web page, not a classic windows application. For 1154
example, the user single clicks a button to activate it rather than double clicking.
The About Box reports the following editable user information: Licensed User 1154
Name, Company Name, and Total Assurance Plan ID.
The About Box reports the following system information: the build number of 1154
the software, the installed service packs, and the installed options.
The Pro Window is dockable with an Always on Top and an Autohide setting. 1154
The docked state is stored for each operating system user.
All activities initiated in the software are assigned to the currently logged in user. 1154
Multiple Empower applications may be run simultaneously. 1154
During login, if more than one database is available, the user may choose which 1154

database to log into.

When logging out of Empower software, the user will have the option to close
any open Empower applications, or lock them and leave them running.
1154 3
Locked applications may be unlocked by the user who originally locked them. 1154
Unlocking is done by the user logging into Empower again.
The Login Window provides simple access to the most commonly used 1154
functionality in Empower:
• Running Samples
• Reviewing Information
• Processing Data
• Printing Reports
• Browsing Projects
• Configuration and System Administration
The software will allow multiple people to independently log in to a single 1154
workstation or client.
Multiple logins to a single workstation or client may be disabled. 1154
Multiple logins on a single client or workstation will use a single connection to 1154
an individual database.
Multiple logins on a single client may be done to different databases. 1154
Empower allows a default database to be defined such that the user does not have 1154
to specify a database during login.
After clicking the Run Samples button, a Use QuickStart button is located in the 1154
Run Samples dialog to allow the user to start the QuickStart interface.
Project Window
A project is the object that holds all Empower 3 information such as data (raw and processed)
methods and view filters. The Project Window provides the main access to projects and their
associated data.
Function Functionality Build

Not Present in
QuickStart
A Method Difference utility is present in order for a user 1154
to easily determine what changes have been made to a
method over time.
In a Full Audit Trail Project, a comment is required for 1154
deletion of data or methods.
Ability to deep copy/paste or shallow copy/paste 1154
information into projects, depending on system policy
and user privilege. (deep = all audit trail information is
maintained, shallow = no audit trail information)
Project Audit Trail information is available. The Project 1154
Audit Trail cannot be purged
Empower allows copying of results, result sets and 1154
custom fields from one project to another and to/from the
Windows file system. All mechanisms which support
copying Empower objects, like drag and drop, the Copy
To Project menu item, etc. will be extended to be enabled

in the Result, Result Set and Custom Fields.

A user has the ability to lock a channel and then, no more
results may be saved which reference it. Channels can
1154 3
later be unlocked. The user must have ‘Lock Channel’
privilege to lock a channel and ‘Unlock Channel’
privilege to unlock a channel.
The quantitate only button is present in the Processing 1154
dialog. This notifies the background processing that
quantitation should be performed using existing
integration and calibration information.
Multi-Project mode allows the user to use a single project 1154
window to view data from multiple projects √
simultaneously.
The Cancel Fetching message box provides a mechanism 1154
to stop fetching data when updating a view.
Empower 3 allows copying of sample sets, injections and 1154
channels from one project to another and to/from external
devices.
View As menu items are available. For example, to 1154
‘View’ sample sets ‘As’ injections, to ‘View’ results
‘As’ sign offs or to ‘View’ samples ‘As’ results. You can
also view audit trail information and instrument method
information using this capability.
Dragging and dropping and copying and pasting 1154
functionality is available to copy items between projects
and to and from the Windows file system.
The project window can appear in ‘Data Selection Mode’ 1154
if accessed via the Process Data, Review Data, or Print √
Data buttons located in the Pro Window. This mode is a
convenience feature.
Project Audit Trails can be enabled. This functionality 1154
specifies whether or not users are required to describe
changes to any method, method set, sample, template,
result, or calibration. It also determines whether or not
the Alter Sample history is generated and whether or not
to retain all versions of all methods in the database.
Method History (part of the Audit Trail functionality) as 1154
available in the Project Window.
Any altered record is automatically flagged with a check 1154
mark in the altered field.
All method and result changes may be determined by 1154
viewing the version number of the method or result,
respectively.
Methods may be locked to prevent modification. Once 1154
locked, a method cannot be unlocked but a new version
can be created using a new method name to differentiate
it from the locked method.
The user can acquire data, create methods, process data, 1154
review results, generate reports, and manage information
using the menus, views, and tools from the Project
window.
Double-clicking on an item(s) in the view table expands 1154
that item to a corresponding view. For example, double-
clicking on a sample set will display corresponding
injection items in Injection view. Double-clicking an

injection will display corresponding channel items in

Channel view. Double-clicking a result set will display
corresponding result items in the Result view.
3
The following types of methods are available in the 1154
project window:
• Instrument
• Processing
• Report
• Export
• Sample Set
• Sample Set Method Template
• Method Set
Instrument methods are specific to the specific system 1154
configuration, but may be used with all systems of
identical component configuration.
All changes are automatically tracked within the 1154
embedded Oracle database.
Process Only Sample Sets – Empower 3
• Allow combining disparate injections into a
sample set post- acquisition
• Allow flexibility in processing
• Allow combinations for use of individual
injections in MVM
• Allow combinations for use in Dissolution/CU
multi-phase studies
Method comments and System comments are available Empower 3
upon saving a method (independent from audit trail
comments on these objects).
Views
The View Table displays information that corresponds to the selected view and view filter.

Not Present in
QuickStart
The following views are available and allow the user to View Filters and 1154
examine specific information stored in the Empower 3 Custom Fields
database. views are not
Sample Sets - A set of samples grouped together during available in the
sample loading and acquisition QuickStart
Injections - Unprocessed raw data, includes all channels Interface
from a single injection
Channels - Individual raw data channels
Methods - Instrument, processing, report, export, sample
set. method sets and sample set method templates
Result Sets - Set of results generated from a processed
sample set
Results - Processed raw data generated from a channel of
data
Peaks (version 3.2) - Peaks (compounds, PDA peaks,
GPC peaks, GPC/V peaks, System Suitability peaks)
Sign Offs - Displays all data that has been signed off.
May contain the following fields: Result ID, Signoff Full

Name (username), Signoff Reason, Signoff Date, Signoff

ID, Signoff Method ID, Signoff Method Name, Signoff
Method Date, and Signoff Method Version.
3
Curves - Calibration curves for LC, IC, GC, GPC/V, and
GPC/V molecular weight distributions
View Filters – displays as view filters present in the
project and allows them to be deleted if necessary.
Custom Fields – All custom fields (created for each
project in Configuration Manager)
Audit Trails – Displays audit trail entries for project
information. May contain the following fields: Date,
User, Action, and Details for each change This view is
displayed only if the project has Full Audit Trail on.
Fractions View – Displays Waters Fraction Collector III Empower
(WFC III) fraction information. 3
View Filters
View filters limit or tailor the types of information displayed by the view. By creating and
applying different view filters, you determine what information appears in the view table as well
as the sorting order of this information.
Note: Although existing view filters can be used in QuickStart, new view filters cannot
be created.

Not Present in
QuickStart
Wildcards (% and ?) can be used with criteria set in a view √ 1154
filter.
When saving a view filter, it can be defined which √ 1154
software interface the view filter is useable in.
View filters can be designated as Public (available to any √ 1154
Empower user) or Private (available only to the user that
created the view filter).
Default view filters are available to aid new users. 1154
Just-In-Time view filters are temporary view filters which 1154
allow the user to enter variable information to complete
them before they are executed. The user specifies which
fields the user should be prompted for by using a special
syntax in the view filter editor. The ‘#’ character in a field
condition is used to trigger the project window to prompt
the user to enter conditions for that field.
A View Filter Wizard is available for assistance in √ 1154
creating view filters.
The ‘Group By’ functionality allows you to create a view 1154
filter that will sort out rows according to the maximum or
minimum values of specified columns. This feature, for
example, allows you to create a view that displays only the
most recently processed result for each channel, regardless
of how many times the channel has been processed.
The ‘Create a Condition’ functionality provides guidance √ 1154
as to how to specify a condition for a particular column in

the view filter.

Clicking the Update button to the right of the Filter By
drop-down list rescans the Empower database using the
1154 3
current view filter and displays the most current available
data.
The view filter table allows for AND-ing and OR-ing 1154
column conditions.
When using the View As capability, the view filter that 1154
was last current in the destination view is used to display
the selected data.
Methods, Channels and Results contain a Source S/W Info 2154
field describing the S/W version, installed service packs
and source database on which they were created.
The Sample Set view includes a Sample Set Acquired By 2154
field.
The Channels and Injections views include an Instrument 2154
Method Name field.
The Injections view includes Column ID and Column 2154
Injections fields.
Tools
The Toolbar displays shortcut buttons that provide quick access to the primary commands used in
the Project window.

Not Present in
QuickStart
The following tools are available to allow the user to Compare and 1154
perform various operations on data stored in the Empower Projects Available
database: tools not available
Review - Displays Review, where you perform data in QuickStart
processing and analysis of acquired data. Interface
Compare - Displays Compare , where you compare
calibration curves or GPC/V molecular weight
distributions selected in the Project window Curves view,
or where you overlay chromatograms selected in the
Project window Channels view.
Preview - Displays the Open Report Method dialog box,
where you select the report method to be used to print your
information. After you select the report method and click
OK, the Report Publisher Preview window appears with
the selected information displayed exactly as it appears
when printed (using the selected report method). You can
preview data, method or method set contents, calibration
curves, and so on. Reports can be interactively modified
as necessary.
Process - Displays the Background Processing and
Reporting dialog box, used to batch process samples, print
reports, and export data during processing.
Print - Displays the Background Processing and
Reporting dialog box, used to print reports based on the
data selected in the view table. You can print sample sets,
injections, channels, results, result sets, peaks, curves,

method sets, processing methods, and instrument methods.

Export - Displays the Background Processing and
Reporting dialog box, used to background export data
3
selected in the view table. You can export sample sets,
injections, channels, results, and result sets.
Alter Sample - Displays the Alter Sample window, where
you can modify user-entered data associated with a sample
or sample set such as Sample Name, Sample Type and
Component Amounts, etc. Alter Sample is grayed out
when in the Multi-Project mode, Global Projects view.
Run Samples - Displays Run Samples, which provides
full control over chromatographic system instruments, and
allows for baseline monitoring, sample loading, data
collection, and interactive methods development. This
tool is grayed out if you do not have any privileges that
allow you access to Run Samples.
Projects Available - Displays the Projects Available
dialog box, where you can add available projects to the
Project tree, remove projects from the Project tree, or
update a project in the Project tree. This button is active
only in the Multi-Project mode .
Copy - Copies selected view table contents (for example,
an instrument method) to the Windows Clipboard.
Paste - Pastes the contents of the Windows clipboard into
the current project.
Help - Enables context-sensitive Help for the window.
When you click the tool, then subsequently click an area
or item in the window, a popup explanation of the area or
item appears. To reactivate the tool and close the popup,
click the tool again. To close the popup only, click the
popup or anywhere in the window except the Help tool.
Create Process Only Sample Set – Allows creation of Empower
Sample Set post-acquisition from any raw data (sample 3
sets, injections, channels)
Alter Sample
From the Alter Sample window you can modify acquired sample sets, channels, or injections.
You can correct errors made while loading samples, change sample identifiers, and enter
component amounts and custom field information after acquisition.
Function Build
If injection lines of a sample set do not contain any injections, they will get 1154
highlighted in the Alter Sample editor. Those highlighted lines will not be
editable while the rest of the lines remain editable.
View As menu items are available in the Alter sample editor. Select sample lines 1154
from the table and select a View As menu item from the right mouse context
menu. The Project Window will display data or results if the request is met.
There are four types of requests (menu items).
• View As Sample Sets
• View As Injections
• View As Channels
• View As Results
Dissolution capabilities (Bath, Vessel, and Draw Time columns) are available in 1154
the table.

In the Alter Sample window, you have the ability to ‘Copy Components’ from a 1154
processing method or a method set.
Samples can be given ‘Labels’ in Alter Sample. Labels can be used during 1154
3
processing and printing to perform bracketing. They can also be used with
Derived Channels and custom fields.
The ‘Autofill’ functionality is available in Alter Sample. 1154
Sample History (part of the audit trail functionality) can be seen in Alter Sample. 1154
Sample labels of the default syntax, i.e. S0101, S0102, U0101, etc. are 2154
automatically updated when the sample type of a sample set line changes. When
the sample type changes from Standard to Unknown, Sxxxx will be changed to
Uxxxx. When the sample type changes from Unknown to Control, Uxxxx will be
changed to Cxxxx. Additionally, label references will be modified if they match
the label which is changed.
An Apply Table Preferences toolbar is implemented (provides functionality 2154 FR5
similar to View Filters) Although initially conceived for Method Validation,
this capability is available to all users.
Compare
Function Functionality Version

Not Present in
QuickStart
The Compare application may be launched from the 2154
Project window with data from multiple projects. Also
within the allowed data types (2D Chromatograms, √
Results, LC Calibration Curves, GPC Calibration Curves,
and Distributions), data from one or more projects may be
dragged/dropped into Compare from the Project window.
Import / Export
Note: Although existing export methods can be used in the QuickStart interface, new export
methods cannot be created.
Function Functionality Version

Not Present in
QuickStart
Data can be imported into Empower in the following 1154
formats:
• AIA (ANDI)
• ExpertEase (860)
• ASTRA text data
• PD ASCII data
• MassLynx
Data can be exported from Empower 3 in the following 1154
formats:
• ASCII
• AIA (ANDI)
• PDF (processed data only)
• EMF (processed data only)
• OpenLynx
Importing and exporting ASCII PDA spectra is supported. 1154

Any file that may be generated via exporting may also be 1154
emailed.
Multiple page reports are exported as a single file. 1154
3
You can specify to export/email fields and report tables √ 1154
via the export method in ASCII format.
Run Samples
The Run Samples Window is where data acquisition and instrument control takes place. Use Run
Samples to:
• Control instruments, change instrument parameters, and save changes to the instrument
method.
Monitor the baseline and look at Real-Time plots of data (wavelength or spectra).
Load samples (single sample or sample set).
Acquire data from either a single injection or a sample set.
The main components of this window are:
• The Single Inject page that provides parameters and controls for acquiring a single injection
(accessed by clicking the Single tab).
• The Develop Methods button launches a wizard that allows you to develop an instrument
method, edit an existing processing method, define derived channels, and save the methods in
a method set.
• The Samples table that displays an editable, ordered list of samples currently loaded in Run
Samples (accessed by clicking the Samples tab). When saved, the samples and their
associated operating information (function, vial number, injection volume, method set, and so
on) comprise a sample set method.
• The Sample Sets table that displays an ordered list of sample set methods currently running
or queued to run in Run Samples (accessed by clicking the Sample Sets tab). The currently
running sample set method appears in red.
• The Running table that displays the currently running sample set method (accessed by
clicking the Running tab). When this table is displayed, it appears as an exact copy of the
Samples table. Rows that have been run or are in process are displayed in red. This table
allows you to interrupt acquisition so that you can modify the sample set method.
• The Monitor panes that display up to four real-time plots of channel data as the data is
acquired. Allows you to overlay 2D chromatograms, customize a PDA channel, and so on.
• The Instrument Control panes that display the current instrument method, solvent delivery
parameters (flow rate, gradient percentages, current pressure, and pressure limits),
temperature parameters and manual instrument controls such as the Change Flow, Stop Flow,
Monitor and Setup buttons
• The Status bar that displays current status codes and injection information (current sample
set, current vial, current injection and current run time) before, during, and after data
acquisition
• The Run Mode Drop-Down List Box that displays a list that lets you view or change the run
mode of the currently running sample set method, or set the run mode when acquiring a single
injection. Run modes are: Run Only, Run and Process, and Run and Report.
• The Interactive System Suitability Drop-Down List Box that displays a list that lets you
view or change the interactive system suitability mode for the currently running sample set
method, or set the interactive system suitability mode when acquiring a single injection.
System Suitability options are: Continue on Fault, Stop on Fault, Next Sample on Fault, Next
Sample Set on Fault, and Reinject on Fault.

Function Build
3
When data is acquired, the database version and the software build number 1154
used for acquisition is stored with the channel information. (This information
is blank for data acquired using Millennium32 Software.)
Ability to acquire an RF Internal Standard type sample. 1154
No printer is required unless the run mode is Run and Report. 1154
Detail is provided for instrument errors to indicate the instrument where the 1154
failure has occurred (sometimes this is not possible).
Prep Inject functions (Inject Immediate Standards, Inject Immediate Samples) 1154
are added to allow a large volume sample to be manually loaded onto the
column.
A sample set shutdown method can be (optionally) specified in the Run 1154
Sample Set dialog.
A plate editor is available to configure plates when using the 2790/2795 or 1154
other autosamplers. Samples can also be easily loaded into the sample loading
table using this editor.
A Sample Set Method Wizard and a Sample Set Method Template Wizard are 1154
available to automatically create sample sets with or without bracketing. (The
Plate Editor is available in these wizards.)
The user has the ability to ‘Re-Inject Samples’ or to ‘Finish an Interrupted 1154
Sample Set.’
The user has the ability to ‘Alter a Running Sample Set.’ 1154
Data that is currently being acquired can be brought into the Review Window 1154
for processing and manipulation.
Component Amounts can be entered in the Run Sample window. 1154
The user has the ability to abort acquisition at any time deemed necessary. 1154
The real-time plot displayed in the Run Samples window can be customized in 1154
various ways. For example, the user has control over the x- and y-axis scaling
and whether or not to overlay or even display the plots.
The ability to display Pressure in Selected Units: PSI, Bar, Kpa 2154
During acquisition of 2996 data, you can view a real-time max plot display 2154
Time Calculator: Shows time remaining for the following: 2154
• Sample Set being created
• Current Running Sample Set
• Current Running Sample Set + Queued Sample Sets
Solvent Calculator: Shows amount of solvent required for the following: 2154
• Sample Set being created
• Current Running Sample Set
• Current Running Sample Set + Queued Sample Sets
The ability to Pause and Resume a Sample Set 2154
Optional “logic” when inserting vials into Sample Set: Can force sequential 2154
vial numbering
The MS tune and calibration files are available for selection on a sample set 2154
line basis in Run Samples. The tune and calibration files are used for the
injection on that particular line.
Automatic vial numbering can be enabled/disabled with the Force Sequential 2154
Vials check box in the customize menu in Run Samples and QuickStart.
Rectangular areas copied from a spreadsheet can now be pasted into the 2154 FR2
Sample Set Table. Additionally, rectangular areas from a running Sample Set
in one project can be copied and pasted into the Sample Set Table in another
project.

Run Samples Toolbar

3
This toolbar displays shortcut buttons that provide quick access to frequently used commands in
Run Samples. You can drag the toolbar (dock) to another location in Run Samples (for example,
to the right edge of the window) or anywhere on the Windows desktop.
Function Build
The following tools are available: 1154
Load - Displays the Load Samples dialog box, which contains options for
loading samples into the Samples table
Wizard - Creates a new sample set method using the Sample Set Method
Wizard
Save - Displays the Save Current Sample Set dialog box, which allows you to
name and save the sample set
Run - Displays the Run Sample Set dialog box, which allows you to run the
selected sample set
Abort - Displays the Abort Options dialog box, which contains options for
terminating data acquisition. This button stops acquisition, but does not stop
pump flow
Plates - Displays the Define Plates for Sample Set Method dialog box, where
you set up plate type and position, and define vial/well injection locations for
your sample set method (for systems that use plates)
Amounts - Displays the Component Editor, which allows you to enter
component data for each sample
Review - Starts Review, which allows you to create a processing method with
the currently acquired data and to view processed results
Cut - Cuts the selection and puts it on the Windows Clipboard
Copy -Copies the selection and puts it on the Windows Clipboard
Paste - Pastes the Windows Clipboard contents to the insertion point
designated by the cursor
Help - Enables context-sensitive Help for Run Samples. When you click the
tool then subsequently click an area or item in the window, a popup
explanation of the area or item appears. To reactivate the tool and close the
popup, click the tool again. To close the popup only, click the popup or
anywhere in the window except the Help tool
Sample Loading Table
Function Build
The following columns are present in the Sample Loading Table to control 1154
sample acquisition parameters. Some columns are self-explanatory, the others
are described.
Vial
SampleName
Label - Use this column to mark (label) each Inject function row in the
Samples table on which you want Empower software to perform a Calibrate,
Quantitate, or Report function. When Empower software runs Inject function
row(s) that contain a particular label in their Label column and then encounters
a matching label in the Label Reference column of a subsequent row (one that
contains a Calibrate, Quantitate, or Report function), Empower software
performs the Calibrate, Quantitate, or Report function on all preceding rows
with the matching label.

Function - Use this column in the Samples table to specify the function to be
performed by each row in the Samples table. Available functions include,
Inject Standards, Inject Samples, Inject Controls, Inject RF Internal Standards,
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Inject Immediate Standards, Inject Immediate Samples, Purge Injector, Purge
Detector, Equilibrate, Condition Column, Calibrate, Quantitate, Report,
Summarize Custom Fields.
Processing - Use this column to control processing and system suitability
actions for rows in the Samples table (by overriding the Run Mode and
Interactive System Suitability selections in Run Samples). The processing and
system suitability options in this column are: Don’t Process or Report, Don’t
Report, Normal, Ignore Faults, and No Sys Suit.
Method Set/Report Method - Use this column to specify either the method
set to be used with the associated function or the report method to be used with
the associated Report function.
Label Reference - Use this column to mark a Calibrate, Quantitate, or Report
function row with a label that matches the label in the Label column of
preceding Inject function rows. Empower software performs the specified
Calibrate, Quantitate, or Report function on those inject function rows
previously acquired that contain the matching label in their label column.
# of Injections
Inj Vol (µl)
Run Time or Dissolution Wait Time (minutes)
Data Start (minutes) - Use this column to specify the time that data collection
is to begin, as measured from injection time. Data Start allows you to delay
start of data acquisition to control the size of the datafile. Data Start is also
useful for eliminating eluent fronts from the datafile.
Next Inj Delay (minutes) - Use this column to add a delay between the end of
data acquisition for an injection and the start of setup for the next injection.
Run time is the time from injection until the system stops acquiring data (and
Next Inj. Delay begins).
SampleWeight - Use this column to specify the sample weight factor by
which the software (during calibration) multiplies the calculated amount or
concentration of each standard component. During quantitation, Empower
software divides the X value read from the calibration curve (of the standard
components) by the Sample Weight value to calculate amounts and
concentrations for each unknown sample.
Dilution - Use this column to specify the dilution factor by which the software
(during calibration) divides the calculated amount or concentration of each
standard component. During quantitation, Empower software multiplies the X
value read from the calibration curve (of the standard components) by the
Dilution value to calculate amounts and concentrations for each unknown
sample.
Level - Use this column to identify all standards in the table that are to have
their amounts averaged together. All vials identified with the same level label
can be averaged together to create a single data point in the calibration curve,
if specified in the processing method.
Column Position (2790 and 2690D with optional Column Selection Valve) -
Use this column to specify the column flow direction through an optional
Column Selection Valve in a Waters 2790 or 2690D.
Auto Additions (2690, 2690D, 2790) - Use this column to perform the Auto
Additions function with the Waters 2690, 2690D, and 2790 Separations
Modules. Auto Additions makes an injection that is composed of sample from
up to ten vials, one of which is the sample vial.
Bath (Dissolution) - Use this column to specify the bath (A or B) in the
dissolution system from which an injection is to be made.

Vessel (Dissolution) - This column indicates the vessel in the dissolution bath
from which a sample is to be transferred.
Transfer Time (Dissolution) - This column indicates the time to transfer (or
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draw) a dissolution sample from the bath to the autosampler for injection. The
Transfer Time field is not editable in the Samples table. You specify the
information for this field in the Bath A or B Transfer page of the New Sample
Set Method wizard or in the Bath A or B Transfer property tab of the
Dissolution dialog box.
An Apply Table Preferences toolbar is implemented (provides functionality 2154 FR5
similar to View Filters). Although initially conceived for Method Validation,
this capability is available to all users.
Built-in, editable custom fields called Column Name and Column Serial Empower 3
Number (for non-ACQUITY systems) are present in Run Samples.
Information in these fields is associated with injections.
Processing
Function Build
Data can be processed using the Traditional integration algorithm (which was 1154
used in Millennium32 Software) or the ApexTrack algorithm which is new in
Empower Software. The primary goals of ApexTrack integration are to
provide an integration package that detects and integrates large and small
peaks equally well in the presence of noisy or sloping baselines, to eliminate
the need for manual integration, and to reduce the time needed to develop a
robust integration method.
Ability to use a Cross Channel Internal Standard (an internal standard peak 1154
from a different channel than the peaks of interest).
The following information about Empower software is stored with the result 1154
during processing: Integration Algorithm (Traditional or ApexTrack),
Software Version, Build Number, Integration System Policies (Use v3.0X
Style Peak Width and Threshold Determination and/or Use v2.XX Style
Retention Time Calculations, or Blank.
A Calibrate Only choice is available in the Processing Dialog. 1154
Processing of an RF Internal Standard is available: the internal standard 1154
peak(s), which is calibrated, is in the same chromatogram as the unknown
peak(s), which is quantitated. The RF internal standard is used as either a curve
reference or a default peak.
Processing codes display informational and/or warning codes that Empower 1154
software encountered while processing the result.
Peak retention times can be assigned to a peak apex by using the highest 1154
physical data point to determine the peak apex or by using a parabolic fit
through the five highest points to determine the peak apex (Traditional
integration only).
Algorithms used during peak integration and processing are published in the 1154
Acquisition and Processing Theory Guide, along with the Empower online
Help files.
If a peak is not found, the peak type field is set to missing, and an error flag 1154
may be configured to alert the user.
Peak grouping is allowed within Empower based on either a time range or a 1154
group of named peaks. A peak group may be given a name and may then be
treated as if it were a single peak for the purposes of quantitation.

Peak names are assigned based on retention time. A peak must fall within a 1154
preset window around an expected retention time. The system may be refined
to select the closest, greatest area, least area, greatest height, least height, first,
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second, third, fourth, fifth, closest negative, or last peak within the window.
Peak integration is based on two global parameters: Peak Width and 1154
Threshold. These parameters may be used in conjunction with timed events to
optimize integration.
Minimum peak areas may be set in the integration method, and they may be 1154
varied for different regions in the chromatogram by using timed events
Minimum peak heights may be set in the integration method, and they may be 1154
varied for different regions in the chromatogram by using timed events.
Various timed events may be configured multiple times within a 1154
chromatogram. The user can set start times, and stop times if appropriate, for
the timed event, which can then be modified graphically.
Timed events available when using Traditional integration include: 1154
• Allow Negative Peaks
• Inhibit Integration
• Force Baseline by Time
• Force Baseline by Peak
• Valley-to-Valley
• Forward Horizontal by Peak
• Forward Horizontal by Time
• Reverse Horizontal by Peak
• Reverse Horizontal by Time
• Force Drop Line
• Force Peak
• Tangential Skim
• Exponential Skim
• Set Minimum Height
• Set Minimum Area
• Set Liftoff
• Set Peak Width (sec)
• Set Touchdown
Timed events available when using Traditional integration include: 2154
• Set Maximum Height
• Set Maximum Width (sec)
Timed events available when using ApexTrack integration include: 1154
• Allow Negative Peaks
• Detect Shoulders
• Gaussian Skim
• Inhibit Integration
• Set Detection Threshold
• Set Liftoff %
• Set Minimum Area
• Set Minimum Height
• Set Peak Width (sec)
• Set Touchdown %
• Valley-to-Valley
Timed events available when using ApexTrack integration include: 2154
• Set Maximum Height
• Set Maximum Width (sec)
• Tangential Skim
Calibration curve types available include: 1154

• Cubic spline
• Point to Point
• Linear
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• Quadratic
• Cubic
• Fourth order
• Fifth order
• Linear through 0
• Quadratic through 0
• Cubic through 0
• Fourth order through 0
• Fifth order through 0
• Inverse Linear
• Log-Log Linear
• Response Factor
Calibration curve types available include: 2154
• Power Curve
Improved ApexTrack Gaussian skims--skimming should occur more 2154
frequently
ApexTrack - Second derivative peak information is preserved when you 2154
perform manual integration changes
ApexTrack - An alert message displays when you integrate beyond the 2154
recommended settings for peak width
Both Named and Timed Groups have been modified to allow the user more 2154
flexibility when specifying how a group peak’s X Value is determined. The
user now has 3 choices instead of 2. The choices are:
• User Entered, Curve or Sum Peaks for Quantitation (default choice)
• Sum Peaks, Curve or Sum Peaks for Quantitation
• Not Calibrated, Sum Peaks for Quantitation
A curve reference (or a default peak) is now allowed to be included in a
quantitated group if the user specifies that the group is not calibrated and the
peaks are summed for quantitation.
When a sample set is processed, any injections which have been reinjected will 2154
only have the most recent injection processed.
(Available with System Suitability Option) Empower includes a new formula 2154 FR5
to calculate plate count as specified by Japanese Pharmacopoeia 15 (JP15), and
retains the current plate count calculation.
(Available with System Suitability Option) Empower allows the calculation of Empower 3
EP, JP and USP signal to noise using noise regions from a blank injection.
MS Ion Ratios and Acceptance Tolerance: Use the ion ratio processing Empower 3
parameters to calculate ion ratio peak values for LC, PDA, GC, IC, CE, CIA
and MS results with acceptance tolerance checking on data related to an
injection.
(Available with MS Option) MS Target Masses: Enter up to five target masses Empower 3
in the sample table and determine if masses are present without modifying the
processing method.
The Spectra to Average field on the MS processing method’s MS Library Empower 3
Search tab defaults to 5 making library matching more reliable.
ApexTrack Integration – Optimized peak width capability for determination of Empower 3
USP Resolution, Relative Resolution and USP Plate Count.
(Available with System Suitability Option) The Baseline Noise Setting can be Empower 3
specified as a minimum number of points or a minimum time.

Derived Channels
A Method Set supports the creation of derived channels. A derived channel is a data channel that
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is created, or derived, from acquired raw data. It is generated by applying some selective or
mathematical operation to the channel data. You define the formula for creating a derived
channel from an acquired data channel (or channels) using the three property tabs in the Derived
Channels dialog box. Derived Channel uses include:
• Baseline Subtraction – Subtracts a (blank) gradient baseline from a 2D chromatogram when

absorbance artifacts, such as solvent UV absorbance, are significant.
• Ratios – Divides the data from one channel by those of a second channel (for example,
Channel A divided by Channel B).
• Derivatives – Applies a mathematical derivative (first, second, third, or fourth) to a data
channel.
• Blending – Applies an operator [+, –, *, ¸, or (P1+2K*P2+B)/(P1–2K*P2+B) for dual-channel
viscometric data] to two data channels (chromatograms) to combine them into a single
chromatogram.
• Smoothing – Applies Savitsky-Golay filtering to average a defined number of data points,
thereby decreasing noise in the data channel.
• Single Wavelength (PDA option) – Extracts a chromatogram at a single wavelength.
• Single Mass (MS option) – Extracts a chromatogram at a single mass.
• Max Plot (PDA and MS options) – Creates a chromatogram in which each data point is
plotted at its maximum absorbance (PDA) or maximum intensity (MS).
• Total Plot (PDA and MS options) – Averages the absorbance values of a specific range of
wavelengths (PDA) or sums the intensities of a specific range of masses (MS).
• Ratio Plot (PDA and MS options) – For PDA, divides the absorbance value at one wavelength
by the absorbance value at another wavelength (PDA). For MS, divides the intensity value at
one mass by the intensity value at another mass.
• Timed Wavelength (PDA) – Extracts chromatograms from a PDA channel based on a table of
starting times and corresponding wavelengths.
• Total Ion Chromatogram (MS option) – Extracts a Total Ion Chromatogram (TIC) from a data
channel.
Function Build
There are three property pages for a derive channel: 1154
First Channel – to define a raw data channel and a constant (optional)
Second Channel – to define an operator, a raw data channel and a constant
(optional)
Filter/Offset – to define smoothing, derivative, RT offset, RT scaling (all
optional)
A ‘Time Program’ derived channel can be created to extract PDA spectra from 1154
different wavelengths at various times.
PDA channels can be extracted on the Second Channel tab. 1154
‘Chromatogram Time Adjustment’ functionality is available to adjust the overall 1154
retention time offset and retention time stretch that can occur when samples are
collected on different systems.
Review Window
The Review Window is an Empower 3 application that allows you to view and interact with
chromatographic data brought in from the Project window, from Run Samples (during data

acquisition), or from Compare. The data can be unprocessed data (sample sets, injections,
channels) or processed data (result sets, results). From Review, you can develop your processing
method interactively with or without guidance from the Processing Method Wizard, process data,
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review calibration curve data, and review processed results.
All data items displayed in Review are listed in the 2D Channels table and 3D Channels table
(PDA or MS data only) at the bottom of the Review Main window, with the selected data channel
in the 2D Channels table displayed as a chromatogram in the Chromatogram plot. A Data tree
appears in Review when sample sets, injections, or result sets are brought into Review. You use
this tree to access the individual samples, injections or results in the set. The table tabs allow you
to switch between the display of 2D channel data and 3D channel data (PDA or MS option only),
or view processed data in the Peaks table.
Review contains the following daughter windows:
• Processing Method Window
• Result Window
• Calibration Curve Window
• Method Set Editor

Not Present in
QuickStart
An option dialog is available to allow the user to always 1154
open the method of choice when in Review:
• Open the method set used to acquire the data
• Open a specific, user-defined method set
• Create a new method set
The user also has the ability to automatically apply the
chosen method set.
Plot scrollbars can be turned on and off and saved as a 1154
preference.
When the calibration curve window is opened for a peak 1154
that was quantitated by another component’s calibration
curve (using a curve reference or a default peak), a dialog
appears informing the user of this fact. The user has a
choice of opening the component’s curve (if any) or the
reference curve.
The instrument method can be opened from Review. 1154
Ability to create a timed group (of peaks) and exclude 1154
any known peaks within the group.
Ability to annotate the displayed plots with lines, arrows, 1154
boxes, ellipses and text for display purposes or for
printing.
A privilege called “Modify Integration Parameters” is 1154
available to allow a user to change integration parameters
(only) of a processing method even if the user does not
have the Save Processing Method privilege.

A privilege called “Modify Component Parameters” is 1154

available to allow a user to change component parameters
(only) of a processing method even if the user does not
3
have the Save Processing Method privilege.
The toolbars in the Main Review Window are 1154
customizable. The existing buttons can be removed √
completely or moved to a different location on the
toolbar. Also, the various buttons from all toolbars can
be combined into one toolbar.
The peak markers can be customized in Empower. The 1154
user can choose between four symbols for peak markers –
a triangle, diamond, x, or a hash mark (straight line). The
user can use any of the four symbols for peak start, peak
end or peak valley. The size of the marker can also be
customized.
The processing method is automatically applied to the 1154
active data in Review upon creation of a method with the
wizard.
Auto-Peak Width and Auto Threshold functionality is 1154
available through a System Policy (Traditional
integration only). This automatically determines the
appropriate Peak Width and Threshold parameters for a
chromatogram, without any manual manipulation by the
user. (This feature is available with ApexTrack
integration by default—no system policy is necessary.)
If Auto-Peak Width and Auto Threshold are turned on, 1154
the processing method wizard adapts to this functionality.
It is possible to define an internal standard(s) when using 1154
the processing method wizard.
Control samples can be defined, acquired and processed. 1154
The ‘Control Value’ and ‘% Deviation’ are determined
for this sample type.
Calibration using Response Factors (set in the ‘Fit Type’ 1154
field of the Component tab) is available.
A processing method wizard is available to assist in the 1154
creation of a processing method.
During Traditional integration, a quadratic curve is fit 1154
through the 5 data points at the top of the peak (the
highest point and the 2 points on either side) to determine
peak retention time and height. This functionality can be
turned off using a System Policy, in which case
Millennium32 version 2.15 integration will be performed
with the retention time defined as the highest data point.
During ApexTrack integration, peak retention time and 1154
height are generally obtained using a 5-point quadratic
fit. If a 5-point fit cannot be obtained a 3-point quadratic
fit or the time of the second derivative apex is used.
When standard components are fitted on a calibration 1154
curve, the ‘Calculated Value’ and ‘% Deviation’ is
determined and reported.
Standards can be calibrated and samples can be 1154
quantitated using component values expressed as either
‘Amount’ or ‘Concentration.’
Components may be manually identified using the √ 1154
Manually Identify Peaks button.

Peaks may be manually integrated by using the mouse to 1154

draw a baseline under the desired peak, and saving the
result. Areas and heights are automatically calculated
3
after the baseline has been drawn.
Automatically integrated peaks may also be manually 1154
modified, by dragging either the liftoff or touchdown
point.
Manually integrated peaks may be used for any further 1154
calculation that an automatically integrated peak may be
used for.
Manually integrated or modified peaks are designated in 1154
the result table by a lowercase letter describing baseline
type, as opposed to an uppercase letter for automatic
integration. Such integration type parameters allow
tracking of each change made to each peak in a
chromatogram.
System Suitability and other calculations may be 1154
performed on manually integrated peaks.
Individual components may be quantitated based on 1154
height, area, or internal standard independently of other
components within the same method.
The following chromatogram scaling choices are 1154
available:
• Autoscale
• Scale to highest peak
• Scale to second highest peak
• Scale to % of highest peak
• Scale to baseline
Un-Do Last Integrate added to Edit menu. 2154
Zeroed Baseline Display. The ability to show each plot as 2154
a baseline corrected display. Provides an excellent way
to show ‘real’ peak shapes for unresolved peaks and the
ability to view the peak shapes unaffected by either
sloping or curved baselines
Right Click functionality to add Integration Events 2154
The View > Processing Method Layout menu will open 2154
the processing method window and switch the processing
editor to the Components tab to allow users better access
to the Component table and integration events.
Ability to re-apply preferences (File > Restore Screen 2154
Preferences)
The ability to edit the Time Offset, Smoothing Type, and 2154
Smoothing Level using the 2D Channel table rather than
the processing method or a derived channel. These fields
initially display the time offset and smoothing parameter
values that are currently used to adjust the 2D channel.
The user is allowed to edit these fields and the time offset
and smoothing parameter values entered here are then
copied into the appropriate set of time offset and
smoothing parameters values in the processing method.
Additional sample information can be added to plots. In 2154 FR2
the plot properties for the Review utility, additional
Legend fields can be selected and displayed on the plot.
The location of the legend will be dependent on the mode

of Overlay selected. Because this additional information

is part of the plot, it will remain with the plot if the plot is
selected and copied into an external application such as
3
Waters eLab Notebook™ Software.
Peak names can be added or edited "graphically" through 2154 FR3
the use of a right-click selection. A menu choice of
Add/Edit Component Name is present in the context
sensitive menu displayed when the user uses the right-
mouse click. When selected, a dialog box appears that
allows the user to enter a name for the integrated peak to
be used when the peak is quantitated or calibrated.
Review Main Window Toolbar
The Review Main Window Toolbar displays a series of shortcut buttons providing quick access to
the primary commands in the Review Main window.

Not Present in
QuickStart
Chromatogram and Plot Toolbar The following tools 1154
Overlay - Switches the overlays of all 2D chromatograms are not available in
listed in the 2D Channels table. When chromatograms are the QuickStart
overlaid, selecting this command removes the overlaid toolbar: Scale to
chromatograms, plotting only the chromatogram selected Peak, Scale to
in the 2D Channels table. Chromatogram,
Scale to Peak - Scales the selected chromatogram to the Autoscale,
height of the selected integrated peak. If there are overlaid Manually Identify
chromatograms, the software applies the scaling of the Peaks, Peak Apex,
selected peak to the other overlaid chromatograms. Peak Inflection,
Scale to Chromatogram - Autoscales the selected Peak Valley, Peak
chromatogram (from the multiple overlaid Offset, Maximum
chromatograms) and applies the scaling to the other Impurity Pass 1-4
overlaid chromatograms. and Library match.
Autoscale - Autoscales each overlaid chromatogram to its These functions are
highest and lowest points. If there is a single available in the
chromatogram, Autoscale redraws the chromatogram to its QuickStart menus.
highest and lowest points.
Show Events - Plots all detection and/or integration events
specified in the Processing Method window (Integration
property tab) on the displayed chromatogram. Event
markers appear as lines at the specified event start and end
times. You can click and drag the vertical line in each
event marker to modify the start or end time of an event.
The modified event time also changes in the Processing
Method window (Integration property tab.
Show Components - Displays component markers in the
Chromatogram plot. Component markers appear (in the
form of inverted Ts) within the Chromatogram plot, based
on the component data in the processing method. The
width of a "T" marker indicates the width of the retention
time window for its corresponding component. You can
drag the vertical line in each marker to modify the
component retention times and retention time windows of
an individual component or several components

proportionally.
Manually Identify Peaks - Displays component markers
as vertical lines on top of the integrated peaks in the
3
chromatogram, allowing you to manually re-identify any
misidentified peaks by placing one of the lines on a peak
Integration Toolbar
Peak Width - Automatically determines the peak width
value that is used to calculate a data bunching factor,
which is applied to the raw chromatographic data during
peak detection. During peak detection, the integer product
of Peak Width and the sampling rate (at which the data
was acquired) divided by 15 determines the number of
points bunched together to produce a single point in the
chromatogram. The Peak Width setting is automatically
copied into the Processing Method window (and is saved
as part of the processing method). Note: If the system
policies specify “Use V3.0x Style Peak Width and
Threshold Determination”, Empower software uses the
selected peak to set the peak width.
Threshold - Automatically determines the liftoff and
touchdown values (minimum rate of change of the signal)
for peak detection based on the baseline in the
Chromatogram plot. Empower software calculates slope
changes across three bunched data points and compares
this change against the Threshold value. The Threshold
setting is automatically copied into the Processing Method
window (and is saved as part of the processing method).
Note: If the system policies specify “Use V3.0x Style
Peak Width and Threshold Determination”, Empower
software optimizes integration only through zooming an
area of the baseline in the Chromatogram plot that does
not contain peaks and is representative of baseline noise.
Minimum Area - specifies the minimum peak area value
required for a peak to be reported, based on a selected
peak in the Chromatogram plot of the Review Main
window. Any peak that has less than the minimum area
requirement is not included in the peak results.
Minimum Height - specifies the minimum peak height
value required for a peak to be reported, based on a
selected peak in the Chromatogram plot of the Review
Main window. Any peak that has less than the minimum
height requirement is not included in the peak results.
Plot Annotations Toolbar
Plot Annotations - Allows the user to draw lines, arrows,
boxes, ellipses and text on a plot before printing.
Extract Toolbar (PDA/MS Option)
Extract Chromatogram – PDA/MS Option - Extracts a
chromatogram from PDA data or MS data displayed in the
Contour plot of Review.
Extract Spectrum – PDA/MS Option - Extracts spectra
from PDA or MS data displayed in the Contour plot of
Review.
Extract Max/TIC Plot - For PDA/MS 3D Channel Data –
Extracts a Max Plot derived channel directly in Review
from the data selected in the 3D Channels table. The
generated max plot is the entire wavelength range

specified in the associated instrument method. The

extracted max plot appears in the Chromatogram plot and
is listed in the 2D Channels table. For MS 3D Channel
3
Data – Extracts a Total Ion Chromatogram (TIC) plot
directly in Review from the data selected in the 3D
Channels table. The extracted TIC channel appears in the
Chromatogram plot and is listed in the 2D Channels table.
SpectrumIndex Toolbar (PDA/MS Option) 1154
Peak Apex – PDA/MS Option - Displays in the Spectrum √
Index plot the peak apex spectra
Peak Inflection – PDA/MS Option - Displays in the
Spectrum Index plot the spectra between the leading and
trailing inflection points (approximate half-height) of the
peak.
Peak Valley – PDA/MS Option - Displays in the
Spectrum Index plot the spectra in the valley between two
fused peaks or in the baseline between resolved peaks.
Allows you to compare peak maximum spectra with the
valley spectrum.
Peak Offset – PDA/MS Option - Displays spectra
extracted between the peak apex and liftoff and between
the peak apex and touchdown. Offset is a selectable
percentage of baseline from the peak apex to the start of
peak detection and to the end of peak detection. Offset is
specified in the Spectrum Index property tab.
Maximum Impurity – Pass 1 – PDA Option - Displays
the spectrum where the ratio of purity angle to noise angle
is greatest, as calculated by Peak Purity testing.
the Maximum Impurity spectrum for the second purity
pass.
the Maximum Impurity spectrum for the third purity pass.
the Maximum Impurity spectrum for the fourth purity
pass.
Library Match – PDA or MS Option - Displays the best
library match found using the PDA or MS processing
method parameters.
Run Samples – Allows user to open Run Samples directly Empower
from Review. 3
Alter Sample – Allows user to modify meta data directly Empower
from Review. Review will use updated meta data after 3
saving in Alter Sample.
Preview All Results – Allows user to bring all saved Empower
results in Review directly into Preview. 3
Save and Preview All Results – Allows user to save all Empower
unsaved results and bring them into Preview. 3
Processing Method Window
Use the Processing Method window to define a processing method. The window is divided into
multiple property tabs in which you enter application-specific information to customize
integration, define how to calibrate standards and quantitate unknowns, enter component
information, and define option-specific processing parameters.

The following property tabs are available:

• Integration
3
• Components
• Default Amounts
• Named Groups
• Timed Groups
• Pattern Match (Pattern Match option)
• Suitability (System Suitability option)
• Limits (System Suitability option)
• Noise and Drift
• Purity (PDA option)
• PDA Library Search (PDA option)
Function Build
The Integration tab defines detection/integration parameters for the entire 1154
chromatogram, and defines time-specific detection/integration events. Fields
available include the following:
• Peak Width
• Threshold
• Minimum Area
• Minimum Height
• Start (ApexTrack integration only)
• End (ApexTrack integration only)
• Liftoff % (ApexTrack integration only)
• Touchdown % (ApexTrack integration only)
• Various Integration Events
The Components tab describes the sample components to be 1154
calibrated/quantitated, how calibration and quantitation are to be performed, and
how these components are related to each other as peaks in a chromatogram.
Fields available include the following:
• Average By
• Update RT
• Name
• Retention Time
• Migration Time (CIA/CE Option, replaces Retention Time)
• RT Window
• MT Window (CIA/CE Option, replaces RT Window)
• Peak Match
• Y Value
• X Value
• Fit
• Weighting
• Internal Std
• RT Reference
• Rel Resol Reference (System Suitability Option)
• Curve Reference
• Relative Response
• Must
• Default Pk
• Default Pk Start, Default Pk End
• Default Units
• Type

• CCompRef1, CCompRef2, CCompRef3

• CConst1 through Cconst7
The Default Amounts tab defines component quantities for each standard 1154
3
(external or internal).
The Named Groups tab groups peak by name, allowing you to group individual 1154
peaks together for processing as a single peak.
The Timed Groups tab groups peaks within a specific time window, allowing 1154
you to group individual peaks together as a single peak.
The Pattern Match tab defines chromatogram regions to align and compare. 1154
The selected regions can be superimposed, compared after max-min
normalization, or compared after alignment. (The Pattern Match property tab
appears only when the Pattern Matching option is installed.)
The Suitability tab defines system separation and efficiency parameters, as well 1154
as baseline noise and drift measurements. (Suitability and Limits property tabs
appear only when the System Suitability option is installed.)
The Limits tab specifies the error and warning limits that can be set individually 1154
so that peak values can be monitored as part of System Suitability testing.
(Suitability and Limits property tabs appear only when the System Suitability
option is installed.)
The Noise and Drift tab specifies a section of the chromatogram to be used to 1154
calculate detector noise, drift, peak to peak noise and a segment width to
calculate average detector noise and drift. These calculations are nearly identical
to the ASTM noise and drift calculations.
Additional PDA-Specific Processing Method Property Tabs 1154
The Purity tab defines parameters used in determining PDA peak purity.
The PDA Library Search tab defines how to match PDA peak apex spectra
with PDA library spectra.
Additional MS-Specific Processing Method Property Tab 1154
The MS Library Search tab defines how to match MS peak apex spectra with
MS library spectra and specifies.
Additional Data Rejection fields based on Max Peak Width and/or Max Peak 2154
Height
The ability to use Smoothing via the Processing Method, rather than via a 2154
derived channel.
The ability to use a Time Offset via the processing method, rather than via a 2154
derived channel.
New calibration field for Normalized Intercept Slope Ratio 2154
For Named and Timed Groups, you can specify the source of the Calibration X 2154
Value:
• User entered, Curve, or Sum Peaks for Quantitation
• Sum Peaks, Curve, or Sum Peaks for Quantitation
• Not Calibrated, Sum Peaks for Quantitation
Custom calculated field can be used as the X Value of a calibration curve. This 2154
is specified in the Component Table of the processing method.
Set Maximum Width and Set Maximum Height integration events have been 2154
added to allow more data rejection parameters.
The ability to specify a cross-channel internal standard using the processing 2154
method wizard.

Results Window
The Results window displays the results associated with the current chromatogram selected in the
3
2D Channels table in the Review Main window (and plotted in the Chromatogram plot). The
Results window displays individual peak results (such as Component Name, Retention Time,
Area, Amount), chromatogram results (such as Sample Name, Sample Type, Date Processed,
Processing Method Name), calibration curve results (such as the equation of the line, R, R², Std
Error); purity results and purity plot (PDA); library match results, library match plot, and triple
match plot (PDA/MS); molecular weight distribution results and plot (GPC/V); viscosity results
and viscosity law plot (GPCV); Pattern Match results and Pattern Match quadruple plot (pattern
match). The type of results displayed in the Results window varies according to the processing
method type (LC, GC, IC, GPC, PDA, MS, or CIA/CE).
Calibration Curve Window
The Calibration Curve window displays the calibration curve and calibration data for the current
processing method and 2D channel selected in the 2D Channels table (of the Review Main
window). The calibration curve data is based on the component information listed in the
Components table (Component property tab of the Processing Method window). Once standards
are processed, Empower 3 software generates a calibration curve for each component listed in the
Components table.
Function Build
LC calibration curve field RSD(E): an indication of how close the calibration 2154
points come to the curve (the precision of the data).
LC calibration curve field Norm Intercept/Slope Ratio is calculated for Linear 2154
and Linear through Zero curves.
Method Set Editor
Use the Method Set Editor to create/modify a method set by specifying an existing instrument
method, processing method, report method, and/or export method.
PDA/MS Functionality
Use the PDA functionality to determine the spectral homogeneity of peaks and to perform spectral
matching against a library or libraries.
Use the MS functionality to perform spectral matching against a library or libraries.
Function Build
Ability to extract MS and PDA spectra with a right click in Review. 1154
Ability to extract MS and PDA chromatograms with a right click in Review. 1154
Chromatogram and spectral markers can be moved using the Up/Down and Page 1154
Up/Page Down keys on keyboard.
MS and PDA spectra and chromatograms are extracted in real time as a marker is 1154
dragged across the Contour Plot in Review.
Ability to automatically create a timed wavelength derived channel (based on the 1154
times and lambda max of integrated peaks).
The Multi-Channel Acquisition (MCA) spectrum can be displayed. 1154
After a peak has been calibrated or quantitated, Spectrum Review uses that 1154
component name as the default spectrum name.

The PDA lambda max of the peak apex spectrum is added to the peak table in 1154
Review.
The following plots are modified to utilize a ‘sparse’ data file format 1154
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• MS spectra/library plots
• Contour plots
• Spectrum index plots
• MS triple plots
Combine and average MS spectra by dragging across a section of the 1154
chromatogram with the mouse.
Use multiple regions of an MS chromatogram as a background spectrum which 1154
in turn is subtracted from all peak spectra to produce the extracted spectrum.
Use a Cross Channel Internal Standard (an internal standard peak from a 1154
different channel than the peaks of interest).
An extraction tolerance (+/- AMU) is available in MS processing methods. 1154
The Spectrum Review table allows the Noise Threshold and Peak Separation to 1154
be edited and changed to a new value.
MS continuum spectra can be displayed as centroid spectra. 1154
MS chromatograms and spectra can be exported directly to ACD/Labs software. 1154
Spectra from different channels can be displayed simultaneously in Spectrum 1154
Review.
Peaks can be annotated with their corresponding spectrum name or component 1154
name.
Extraction of a max plot is available in the processing method wizard. 1154
The Wiley and Wiley NIST MS spectral libraries contain the chemical structures 1154
as well as spectral information. When a MS extraction is searched against either
of the Wiley libraries and a library match is found, the chemical structure for the
spectrum is drawn in the plot along with the spectrum. The following plots show
the Wiley structures when a Wiley match has occurred:
• Spectrum Review
• Spectrum Index
• Match Plot
• Triple Plot
Wiley and Wiley NIST library support discontinued 2154
PDA: 2154
> Create a Non-Contiguous MaxPlot
> Enter an extracted channel 'calculation', such as 220+280 (220 nm plus 280
nm) or 250:350 (sum 250 through 350)
> Better Default values for Channel Name of Extracted Channels
> The last 20 user selected Extracted Wavelengths are saved
> Define a wavelength range (bandwidth) over which a chromatogram will be
extracted as a TotalPlot (sum of absorbances within the wavelength range), and a
second region where another TotalPlot will be extracted and automatically
subtracted from the first wavelength range.
> Display MaxPlot in real time
MS: 2154
> Smoothing added to processing method
> Mean smoothing type available (odd numbers between 5 and 31, inclusive)
> Timed Mass Chromatogram (from TIC plot)
> New MS Blank Subtraction
> Automated definition of Cross Channel Internal Standards
> Extract both UV and MS Spectra from contour plot
> Tune and Calibration files stored in database
> Summing Channels – extract multiple masses into single channel

>Injection based and component based expected mass calculation

> ability to control the precision when reporting mass values
in mass spectra
3
> Labeling of spectra works more cleanly, i.e. fewer label ‘collisions’
>A calculated channel type of derived channel allows masses and / or mass
ranges to be added and / or subtracted from other masses or mass ranges.
>Spectrum Review window will default to stack plot mode and include a 'logical'
approach for stacking
> Stack plots will automatically scroll when the viewable area of the plot 2154
becomes so small that each view port is smaller than the minimum size, the stack
plot window will scroll so that one (or more) of the view ports are not shown and
can be scrolled into view.
> Plot annotations are functional in stack plots.
> Stack plots will be modified so that identifying information may be placed over
each view port in the stack plot.
• The information for chromatograms not extracted from 3D data is the
channel name and the 2D channel description.
• For chromatograms extracted from 3D chromatograms, the information
is the extracted channel name, the 3D channel name and the 3D channel
description.
• The information for the Spectrum Review plot in Review is the
retention time, the info field (i.e. Extracted, Peak, Combines, etc.) and
the source field. (The source field for MS spectra now contains the 3D
channel name and the 3D channel description in addition to the sample
name which was previously present.)
• The stack label for MS spectra displays this source field without the
sample name.
> PDA and MS spectra can be extracted at the same time from a 2D or PDA
chromatogram. A new “Extract MS Spectrum” menu item is added to the
contour and chromatogram plot right mouse menu and is only present if a 2D or
PDA chromatogram is selected and at least one MS 3D chromatogram is present
in the 3D channel table.
Report Publisher
The Report Publisher is a graphical interface that lets you interactively create and modify the
contents and design of your report method, including placement and design of custom report
groups. The report method instructs Empower 3 software how to construct and format a report of
selected project data or results.
The Report Publisher includes the Report Groups Tree which is a collection of report groups and
fields defined in some specific manner to provide a level of information and appearance in a
report. The Report Groups tree lists all available groups in a project, including those provided in
the Empower 3 software and all custom report groups created in the project. The types of report
groups include, but are not limited to, chromatogram groups, table groups, calibration curve
groups, method groups, drawing object groups, PDA/MS groups, System Suitability groups,
Dissolution groups and Pattern Match groups.
The Report Publisher includes the Report Page which displays the order, placement, and
orientation of the groups that are included in the actual report. Each block on this page represents
a report group. The groups on this page can be dragged to new locations as desired. You define
the order, placement, size, and orientation of the report groups.

The Report Publisher includes a Preview function that displays data (sample sets, injections,
channels, methods, result sets, results, calibration curves, molecular weight distributions, spectra,
libraries, dissolution data, and pattern match data) based on a report method before you generate
3
the report. After you access Preview with data, the contents of the individual report groups in the
Report Publisher are updated to reflect the actual data.
Function Build
Specify that a report can (or cannot) be used to electronically signoff results. 1154
When using Scaling to % of Highest Peak, values greater than 100% are 1154
allowed.
Undo/Redo is available in the Edit menu in the Report Publisher 1154
Composite groups can be edited without ungrouping them 1154
Extend Group to Fit Text check box available in Field Properties 1154
Multiple groups on the report page can be moved simultaneously 1154
An annotation bar is available in Print Preview. This toolbar allows the user to 1154
draw lines, arrows, boxes, ellipses and text on a given report page before
printing. These annotations affect the current report only and do not become
part of the report method.
A Data Filtering Conditions button (in the Order by tab) allows more 1154
functionality, similar to that found in view filters. This functionality allows
you to specify which data to report, as you can currently do in view filters.
Ability to report the method history of the report method using the Revision 1154
Summary Information check box.
Ability to print Differences from Previous Version on a method. 1154
The Message Center is no longer used to report error information for the report 1154
publisher. Errors are added to the status bar of the report publisher as well as
still remaining on the report itself. A list of errors is available using the new
Errors button in the Report Publisher toolbar.
Ability to modify default settings: 1154
• Paper size
• Paper orientation
• Font size
Ability to set a ‘global’ font for each report method. 1154
Ability to specify and modify the default methods (used when you choose ‘Use 1154
a report method that was generated to be appropriate for the selected data’).
Ability to specify and modify the default groups that appear in the Report 1154
Publisher tree.
The Special Information report group is modified to report the 3 pieces of 1154
information that are entered during software installation and 2 pieces of
reporting information:
• User name
• Company name
• Support plan number
• Job ID for report generation
• Report method ID
Ability to use printer defaults for paper size and orientation. This allows the 1154
paper size and orientation to be governed by the printer setup rather than in the
report method. New report methods have this feature turned on. Updated

report methods have this feature turned off.

Report page length in the editor is 25 pages (was previously 2 pages). 1154 3
In a Full Audit Trail project, a user cannot print a report with a modified, 1154
unsaved report method.
The report method used to sign off a result is traceable. 1154
A plot scaling privilege called “Modify Report Scaling Only’ is available to 1154
allow a user to be able to edit the Scaling property sheet only on plots that are
part of a report method (including locked methods). The method is not
overwritten.
A Result Custom Fields group is available. 1154
A Project Custom Fields group is available. 1154
A Sample History group that tracks changes made in Alter Sample is available. 1154
‘Ordering’, ‘Grouping’ and ‘Summary Functions’ are available in calibration 1154
tables.
An Acquisition Log groups, which track acquisition history is available. 1154
A Sign Off Log group which lists any sign off information is available. 1154
Any plot group is allowed to be rotated. 1154
A Project Information group is available. 1154
The current report can be saved in PDF, EMF and ASCII format. 1154
Reports may be emailed in PDF, EMF and ASCII format using a MAPI 1154
compliant mail system.
A result(s) may be electronically signed off by a user with the appropriate 1154
privileges.
The ‘Result Sign Off’ capability complies with Closed System Electronic 1154
Signatures General Requirements 21 CFR Part 11 Sub-part C. For example,
Empower 3 imparts the ability to use ‘Unique User Accounts,’ ‘Expiring User
Passwords’ and ‘Unique Passwords.’ The software reports ‘Unauthorized
Access Attempts’ uses ‘Sign Off Meanings’ and has a ‘Sign Off Inactivity
Delay.’
The Report Groups Tree is searchable. 1154
The ability to expand or collapse the Report Groups Tree is available. 1154
Header/Footer vs. Main view is available in the Report Publisher. 1154
A Wizard is available to assist in the creation of a reporting group or a report 1154
method.
Reporting groups may be renamed, cut, copied, pasted, dragged and dropped. 1154
‘Snap to Grid’ and other alignment tools (such as ‘Make Same Size’ and 1154
‘Align Right/Left’) are available for ease in formatting your reports.
Special Information report field displays the software revision number with 2154
service pack installed
Scale Report as Percentage of Paper Size 2154
Scale Report to printable area. 2154
Label Peaks with Numbers and Legend (links with Auto-Labeling 2154
functionality in Processing Method)
When an inactivity delay occurs, Preview will remain open. The user will 2154
need to re-authenticate before signing off results.
Instrument Method Name is individually available to place on reports. 2154
Post Run Report group – this report group provides instrument status in Empower 3
information from instruments in a way that enables instruments with no
detector component to report information. The Post Run Report group

provides information only for instruments controlled through Instrument

Control Software (ICS) and does not provide information for instruments for
which the driver is built into the Empower software. Both the Post Run Report
3
and Comprehensive Status Report groups provide status information for
injections that is collected from the instrument during acquisition. The
Comprehensive Status Report does not provide information if the data is
acquired using a chromatographic system with no detector present (for
example, if you acquire only a pump pressure trace). The Post Run Report
group provides information for data acquired on chromatographic systems with
and without a detector component. The Comprehensive Status Report group
reports information acquired from instruments by earlier version of the
Empower software. The Post Run Report group stores information with the
injection. The Comprehensive Status Report group stores information with the
channel.
Chromatogram and other Plot Groups
Chromatogram groups define the parameters to use when printing chromatographic plots,
including specific plot characteristics, data characteristics, overlay information, and so on.
Function Build
In a chromatogram group, “Scale to Highest Peak” allows percentages above 1154
100% (500 % is the maximum).
Chromatogram scaling features are now available in the Spectrum Index Plot. 1154
Plot properties are expanded to include settings for the right and top axis. 1154
Plot characteristics, such as x-and y-axis labels and units, the grid box, etc. can 1154
be chosen to be printed or not printed.
The x- and y- axis units are customizable. 1154
Chromatograms and pump gradients can be overlaid in a single or a stack plot. 1154
Peaks can be labeled with start/end markers, apex markers, component name, 1154
retention time etc.
Peaks can be labeled with its library match (PDA/MS options only) or the scan 1154
number (MS option only).
Peak name placement can be customized. 1154
Peak start/end/apex markers are customizable and sizable. 1154
Available chromatogram scaling is the following: 1154
• Autoscale
• Normalized
• Highest Peak
• Second Highest Peak
• % of Highest Peak
• Scale to Baseline
Chromatogram plots can be rotated on the report page. 1154
Chromatogram plot titles can be assigned. 1154
Legends can be created using user defined fields. 1154
Chromatogram plots can be ordered by a user-defined field(s). 1154
The fonts and colors of a chromatogram can be customized. 1154
Peaks can be labeled with a customized label (something other than peak name 2154
or retention time) and a legend mapping the label to the peak name can be

printed for publishing-quality reports.

A Zeroed Baseline plot group is available. 2154 3
Table Groups
Table Groups define the parameters to use when printing Empower 3 database fields in a tabular
format.
Function Build
Nearly any field stored in the database can be printed in a report table. 1154
Summary tables called ‘Component Summaries’ are available. 1154
The user can choose to print or to not print specific types of peaks such as 1154
known, unknown, missing, internal standards, etc.
The data in tables can be ordered by a user-defined field(s). 1154
The fonts and colors of a table can be customized. 1154
Calibration Curve Groups
LC calibration curve groups define the parameters to use when printing specific curve
characteristics, data points, and so on.
Function Build
Skip printing the calibration curve of the internal standard (using the Data 1154
Filtering Conditions button).
Plot characteristics, such as x- and y-axis labels and units, the grid box, etc., 1154
can be printed.
Calibration curves can be overlaid in a single plot or a stacked plot. 1154
The following scaling types are available: 1154
• Scale to Point
• Scale to Curve
• Normalize
Calibration plots can be rotated on the report page. 1154
Calibration plot titles can be assigned. 1154
Legends can be created using user-defined fields. 1154
The data in tables can be ordered by a user-defined field(s). 1154
Method Groups
Method groups allow you to include Empower 3 method parameters that are associated with one
or more pieces or data.
Function Build
Method-specific items to include on the printed report page are customizable. 1154
User-defined field(s) can order the data in tables. 1154

An instrument method gradient table is individually reportable. 2154
Drawing Object Groups

3
Drawing Object groups allow you to customize your reports using Text, borders, graphics (bitmap
files or enhanced metafiles), and/or lines.
Function Build
All drawing objects are sizeable. 1154
The fonts and colors of these objects can be customized. 1154
PDA/MS Groups
PDA/MS Groups define the parameters to use when printing PDA- and MS-related data.
Including 3D plots, MS comprehensive status reports, contour plots, extracted spectra and
extracted chromatograms, library match plots, peak purity plots, spectra/library plots,
spectra/library tables, spectrum index plots, and triple library match plot.
Function Build
The following groups are available: 1154
• 3D Plots
• Comprehensive Status Reports
• Contour Plots
• Extracted Spectral Plots
• Match Plots
• Purity Plots
• Spectra/Library Plots
• Spectra/Library Tables
• Spectrum Index Plots
• Triple Plots
• MS Internal Standard Peak Plot
• MS Internal Standard Peak Table
In MS Stick Plots, the vertical mass intensities are shown as originating at the 1154
bottom axis of the plot, not 5% above the axis.
Ability to change the scale on user-selectable regions of the plot. 1154
Each amplifier from the amplification table is applied to the plot for the 1154
regions specified, including the start and end region values.
The following plots are modified to utilize a ‘sparse’ data file format 1154
• MS spectra/library plots
• Contour plots
• Spectrum index plots
• MS triple plots
When MS spectra are matched from either the Wiley or Wiley NIST libraries, 1154
the chemical structure can be drawn in the Match Plot, Triple Plot or Spectrum
Index plot.
Support for Wiley and Wiley NIST libraries discontinued 2154
Filtering by peak type is available in Spectrum Index plots. 2154
In Spectrum Index plots, the chromatogram section is automatically zoomed to 2154
the peak or time region of the spectra.

System Suitability Groups 3

System Suitability Groups define the parameters to use when printing special groups related to the
System Suitability option.
Function Build
• Overall RSD Plots
• Peak Plots
• RSD Plots
• Summary Plots
The x-axis of summary plots can be customized with a user-defined field from 1154
the database.
Warning level control lines are available in system suitability summary plots. 1154
Dissolution Groups
Dissolution Groups define the parameters to use when printing Dissolution-specific information.
Function Build
• Dissolution Plots
• Dissolution Tables
Choice for data summarized in table. The allowed fields will include any 2154
numerical peak (peak, GPC/V peak, PDA peak, SysSuit peak) or result fields,
including custom fields. The user will have the choices of reporting Amount
Dissolved, Percent Dissolved or a user selectable field.
Allow Custom y-Axis value for plot 2154
Pattern Match Groups
Pattern Match Groups define the parameters to use when printing Pattern Match-specific
information.
Function Build
• Pattern Match Quadruple Plots
• Pattern Match Out of Bounds Tables
• Pattern Match Result Parameters
Chemical Structure Groups
Chemical Structure Groups define the parameters to use when printing results that contain
chemical structure information.
Function Build
The location of the structures in relation to its corresponding peak can be 1154

defined:
• Automatic
• Above Peak
3
• Left of Peak
• Right of Peak
• Inside Peak
• Chemical Structure fields
• Chemical Structure Plots
• Chemical Structure Library Plots
A Scale y-Axis to Chemical Structure setting is available for plots. 2154
GPC Groups
GPC Groups define the parameters to use when printing results that contain GPC information.
Function Build
The user can configure GPC Distribution Plots to show peak molecular weight 1154
(MP) labels or not.
Preview
Preview is a tool within Report Publisher that you use to view a report as it will appear when printed. In
addition, you can use Preview to review and sign off results (subject to privilege control).
If the appearance of the report is not satisfactory, you can make adjustments to the report method in Report
Publisher to modify the report’s appearance. Preview uses the active report method (from Report
Publisher) as the default report method, but you can specify a different report method to view the report.
You can add annotations to the report in Preview before you print it.
Function Build
The Preview Toolbar consists of the following buttons: 1154
• Open
• Send Mail
• Save Report
• Print
• Cut
• Copy
• Paste
• Previous Page
• Next Page
• Toggle Number of Pages
• Zoom In
• Zoom Out
• Previous Report
• Queue
• Next Report
• Sign Off
• Annotations
• Clear Annotations
• Close

• Help
3
Function Build
A tool button is available within Empower Report Publisher 2154 FR3
/Preview to allow a user to copy certain parts of the report and
then to paste this within another software application.
QuickStart Interface
The QuickStart Interface is a simple, single window that optimizes access to available functionality.
Everything required to run samples and get answers is located in one place. By using a streamlined
interface, QuickStart takes the software’s performance features and makes then as accessible to the
occasional user as they are to the everyday user.
QuickStart consists of the following main buttons in the Navigation Bar which allow different
information to be displayed in the work area:
• Run Samples-allows the user to enter sample information, select acquisition methods and view
real time data acquisition.
• Browse Project-provides access to the Project window where data can be searched for and
selected. Data can then be Reviewed, Previewed, taken into Alter Sample, Processed, etc.
• View Data-allows interaction with data selected within the current project. This view provides
access to Review and Preview.
• View Methods-Allows the user to view, create and/or modify methods. Once View Methods is
selected, three additional options are available in the Navigation Bar: Method Set, Instrument
Method and Processing Method.
• Show Me-allows the user to be lead through the process of common tasks. This Help system
drives the user through the desired process, in essence it presses the appropriate menus and
buttons to guide the user to the completion of the chosen task.
• View Acquisition-controls the display of the acquisition bar, allowing the user to allocate more
screen real estate to the top portion of the QuickStart window.
Function Build
A user has the ability to use QuickStart whether or not they are connected to a 1154
chromatographic system.
The Command bar occupies the left side of the QuickStart window and 1154
provides the following tabs with the following functionality:
Run Samples – allows the user to display either the Sample Queue in order to
enter sample information, select acquisition methods and view real time data
acquisition or the System Status, which includes the instrument control panels
and the real time plot. Refer to the Pro Interface Run Samples section for
details on functionality.
Browse Project – allows the user to see information in the project window
using the various views. When data is selected, buttons which allow the user
to Review, Process, Preview or Report the data are enabled. Refer to the Pro
Interface Project Window section for details on functionality.
View Data – allows the user to display data in either Review mode or Preview

mode. View Data retains the selected data until it is replaced by subsequent
data; i.e. if the user switches to a different view and then returns to View Data,
the window contains the same data as it previously contained. When bringing
3
data into the Review mode, it is possible to ‘replace’ the current data with the
new data or to ‘append’ the current data with the new data. Refer to the Pro
Interface Review Window and Preview sections for details on functionality
View Method – allows the user to create, open, edit and save instrument
methods, processing methods and method sets.
View Acquisition – allows the user to toggle on/off the display of the
Acquisition Bar which contains the real time plot. Turning off the Acquisition
Bar allows the user to allocate more screen real estate to the work area of the
QuickStart window. The Acquisition Bar is not displayed if QuickStart is
being run with no connection to a system.
Show Me – allows the user to start the Show Me Help Tool. This tool
interactively guides the user through common tasks.
Show Me help discontinued 2154 FR5
The Make Single Injection button is enabled whenever the system is idle and 1154
allows the user to quickly make single injections.
A Do Last functionality is available to allow the user to quickly re-acquire the 1154
last sample set, single injection, template method, etc.
When data is being Review in the QuickStart work area, the user has the 1154
ability to Clear All Data.
Configuration Manager is available through the Manage menu in QuickStart. 1154
When in the QuickStart window, the user has the ability to switch between 1154
projects and systems.
Develop Methods button added to "View Acquisition" and Single Inject dialog 2154
box: You can develop a new method set using the Method Set wizard.
New 'Processing Method Layout' for viewing chromatogram and processing 2154
method at the same time
Change Behavior of View Data Button. When Sample Set, Injection, or 2154
Channel selected, View Data will take you to Review
Change Behavior of View Data Button. When Result Set, or Result selected, 2154
View Data will take you to Preview
Ability to edit Report Methods through the QuickStart interface 2154
Open Access User Interface
The Open Access User Interface is a productivity tool. Open Access is designed to ease the
process of sample submission and acquisition and allow users that are unfamiliar with Empower 3
to fully acquire and process data and also report and/or email the results.
The Open Access user needs to provide only minimal information about their sample(s) such as
vial position, injection volume and run time. All methods such as instrument methods, processing
methods and report methods are created ahead of time by a more experienced Empower 3 user.
The Open Access application can be designated as the default user interface.
The system administrator determines and regulates the Open Access user’s privileges, typically
restricting these privileges fairly dramatically.

Empower 3 Software Options
System Suitability Option

3
Processing and Reporting System Suitability Results
The Empower 3 System Suitability software is an optional software application that is fully
integrated into the Empower 3 software. This software option provides System Suitability testing
and methods validation parameters for use in LC, GC, IC, CIA/CE, GPC/V, PDA, and MS
chromatography applications. System Suitability performs statistical calculations on results and
summarizes the information in graphical or tabular formats. With System Suitability, you can
produce reports that show the statistical accuracy and reproducibility of your chromatographic
data. The Empower 3 System Suitability software bases its System Suitability tests on standard
laboratory calculations, including the United States Pharmacopoeia (USP), European
Pharmacopoeia (EP), and Japanese Pharmacopoeia (JP) guidelines and calculations.
The System Suitability option allows you to monitor your chromatographic analysis to ensure
that it is performing within acceptable limits. As described in the United States Pharmacopoeia
(USP), system suitability is the concept that the electronics, equipment, specimens, and analytical
operations constitute a single analytical system, which is amenable to an overall test of system
function.
The System Suitability software is a useful tool for method validation. Method Validation is the
process of determining the precision, accuracy, limit of detection, limit of quantitation,
specificity, range, linearity, and robustness of your method. The usual practice is to perform
method validation once for each processing method and method set.
Use the System Suitability software to help:
• Ensure the performance of your system

• Validate methods
• Track and trend results.
Processing System Suitability Results
Function Build
The following System Suitability fields can be calculated by the software: 1154
• 1 Sigma Plate Count
• Asymmetry (Tailing)
• [Asym @ (10%)]²
• [Asym @ (4.4%)]²
• Asym @ 10%
• Asym @ 4.4%
• EP Plate Count
• JP Plate Count
• USP Plate Count
• K Prime
• Relative Resolution
• Selectivity
• Symmetry Factor
• USP Resolution

• USP Resolution (half-height)

• USP Tailing
• Width @ 4.4%
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• Width @ 5%
• Width @ 10%
• Width @ 13.4%
• Width @ 32.4%
• Width @ 50%
• Width @ 60.7%
• Width @ Baseline
• Width @ Tangent
• Baseline Drift
• Baseline Noise
• f @ 5%
There are two parts to the System Suitability processing method: the 1154
Suitability tab and the Limits tab.
The Suitability tab contains the following parameters: 1154
General Parameters
• Calculate Suitability Results
• Calculate Suitability Results for Unknown Peaks
• System and Separation Efficiency Parameters
• Void Volume Time (min)
Pharmacopoeia Options
Specifies the calculation of System Suitability results according to the
formulas outlined in the
• US Pharmacopoeia (USP)
• European Pharmacopoeia (EP)
• Japanese Pharmacopoeia (JP)
• All
(Based on the specified Pharmacopoeia, System Suitability results such as
selectivity, plate count and resolution are calculated according to the
associated formulas.)
Tangent Percent
Plate Count Type
Baseline Noise and Drift Measurement Parameters
• Maximum Allowable Noise
• Maximum Allowable Drift
• % of Run Time Over Which to Average
• Baseline Start Time (Min)
• Baseline End Time (Min)
The Limits tab allows you to define the range of allowable values you set for 1154
each peak that is to have system suitability testing. The System Suitability
limits you set are used to determine limits shown as minimum and maximum
values in summary charts, to flag result fields in summary tables, and to fault
out-of-range values in printed reports and in the Peaks table in Review.
The Limits tab contains the following parameters:
• Flag Values Outside Limits
• Field Name (for example, Area, RT, Resolution, Plate Count)
• Error %
• Lower Error Limit (LCL)
• Upper Error Limit (UCL)
• Warning %
• Target
• Lower Warning Limit

• Upper Warning Limit

• Ignore Blank Values
• Check Limits
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Always check system suitability limits or only check during calibration or 1154
quantitation.
Warning limit levels are available in addition to the upper and lower error 1154
limits.
Signal to Noise is calculated when using System Suitability. The user 2154
specifies what type of noise to use in the calculation – Baseline Noise, Peak-to-
Peak Noise, Average Peak-to-Peak Noise, Detector Noise, or Average Detector
Noise.
European Pharmacopeia Signal to Noise is calculated when using System 2154
Suitability.
European Pharmacopeia Start Peak to Valley and End Peak to Valley fields are 2154
calculated when using System Suitability.
Width @ Tangent (USP Resolution) allows the user to define how the field is 2154
calculated by entering the tangent percentage.
System Suitability limit checks can be used with summary custom fields (for 2154
example, %RSD)
Reporting System Suitability Results
Function Build
You can present System Suitability data in the following formats on a report: 1154
Summary Plots – Summarizes data for the analysis you select. Can be plotted
in line, bar, or scatter format. Useful for observing trends.
Overall %RSD Bar Plots – Summarizes all peaks for an overall report of
System Suitability.
RSD Bar Plots by Peak – Identifies the problem area when you have a
questionable Overall %RSD plot.
Peak Plot – Illustrates the plate count calculation.
Summary Tables – Present summary data in table form, and calculate
statistics.
Sample-, Injection-, chromatogram- and peak-level fields are available for use 1154
in System Suitability Reports.
Summary calculations (like %RSD) work with System Suitability i.e. limits, 2154
stop on fault.
Pattern Matching Option (not available in Empower 3)
Chromatographic Pattern Matching is an Empower software option that mathematically compares

a sample chromatogram to a method-specified reference chromatogram and identifies retention-
time intervals where the compared chromatograms have significant differences. You can compare
any 2D channel data, including channels extracted and saved from photodiode array (PDA) or
mass spectrometry (MS) data. Pattern Matching uses an alignment algorithm to compare
corresponding retention-time intervals in the reference and sample chromatograms. The algorithm
operates directly on the data. Internal standards are not required nor is traditional integration used.
The alignment algorithm measures and removes changes caused by the following five system
variables:

• Response ratio (between corresponding retention-time intervals of the reference and sample
•
chromatograms)
Retention time offset
3
• Retention time scaling
• Baseline offset
• Baseline slope
If the components in the compared intervals of the reference and sample chromatograms are the
same and are present in the same concentration ratio, the patterns match (align). If there is a
difference between the reference and sample chromatograms (for example, a new or missing peak
or a difference in concentration ratios), the degree of alignment is less. After aligning the
chromatograms, the algorithm calculates the standard deviation (Std Dev) of the differences
between the compared retention-time intervals to quantify the degree of misalignment.
AutoArchive Option
AutoArchive is an Empower 3 software option designed for the Personal workstation

environment. AutoArchive automatically backs up project data based on a schedule determined by
the user and also provides a mechanism to locate samples after they have been archived. You can
easily retrieve archived data because samples are logged when they are generated and their
location and status is tracked as they move through their life cycle. To simplify the search and
retrieval process, additional project and sample archive views are displayed in Configuration
Manager allowing tracking, searching, and retrieval of projects and their samples. You can either
manually archive a project and samples, or schedule an archive task using the Windows®
Scheduler. AutoArchive allows you to track project information, sample information, and sample
custom fields.
For Empower 3 Workgroup of Empower 3 Enterprise, the AutoArchive option is replaced by the
Enterprise Data Manager (EDM) option.
Chemical Structures Option
Chemical Structures is an Empower 3 software option that allows you to place chemical
structures on your plots in Review and on Reports and also allows you to perform structure
searching using view filters. Two levels are available: Basic and Advanced.
Basic Chemical Structures Option
The basic option uses *.MOL files, which are a standard file format in the industry, or MDL ISIS
structures and allows you to:
• Assign structures to components and spectra

• Create structure libraries
• Draw structures on chromatogram and spectral plots (also PDA match plots, triple plots
and purity plots)
• Perform structure searching (whole molecule only)
Advanced Chemical Structures Option
The advanced option is available through ACD Laboratories (Advanced Chemistry Development,
www.ACDLabs.com) and provides all of the basic functionality plus:

• Includes an Empower-enabled version of ACD’s ChemSketch structure drawing software

that adds the ability to create and edit chemical structures directly from the Empower 3
software
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• Allows sub-structure searching
The basic option must be purchased before purchasing the advanced option.
The following Chemical Structure fields are available if the advanced option has been enabled (for
up to 3 structures per component):
• Name
• Description
• Molecular Weight
• Formula
• Structure
Chemical structure information is available on reports in the following groups:
• Structure plots
• Structure library plots
• Existing plot groups (i.e. chromatogram plots, spectral plots, etc.)
• Individual fields (Name, Description, Mol. Wt., Formula, Structure)
Searching for structures and sub-structures is also available using the Chemical Structures Option.
View filters allow you to easily add a structure or other structural information to your search
criteria and quickly retrieve all data that contains the criteria you defined. If you have the
Advanced Structures package, you can search using a substructure as your criteria. This allows
you to search for similar, but not identical compounds.
Dissolution Option
Dissolution is an Empower 3 option that allows you to automate dissolution testing from
dissolution sampling and acquisition to dissolution calculations and data reporting. It can be run
with Bath A, Bath B or both baths with 1 – 8 vessels per bath. A wizard guides the user through
the different dissolution parameters such as transfer amounts and intervals, Q Factor information,
temperature, and paddle speed. Customizable dissolution plots and tables are available to report
your dissolution results.
Function Build
Empty peak amount values are treated as zero for dissolved amount and 2154
dissolved percent calculations.
It is possible to extrapolate the dissolution plot to the origin (0.0) 2154
Process-only Sample Sets allow additional flexibility for Dissolution data Empower 3
analysis
Gas Chromatography (GC) Option
The Empower 3 GC Option allows direct instrument control and digital data collection for Agilent
Technologies gas chromatographs. The following GC instruments can be controlled: 5890 Series
II, 7673 Automatic Liquid Sampler (ALS), 6890, 6890 Plus, 6890N, 6850 and 7683 ALS. When
using two injectors, dual-tower injections are supported for analyses that require maximum
throughput or compound confirmation. GC control through Empower 3 Software is also
compatible with manual injections and headspace analysis.

Waters Data Converter Option 3

The Waters Data Converter Option allows AccessChrom, ChemStation (both 2D and 3D UV data)
and MassLynx data conversion and import into Empower and Empower 2 Software. A new
Waters Data Converter 2 standalone software application is available for Empower 2 and
Empower 3 software.
Empower 3 Enterprise Options

Empower 3 Enterprise Options are designed for the Empower 3 network implementations. These options
provide technology benefits to the entire scientific community by extend scientific information throughout
the corporate enterprise.
Enterprise Data Manager (EDM) Option
Empower 3 Enterprise Data Manager (EDM) option is a new enterprise option that offers
enhanced data management capabilities for archiving chromatographic results and extending the
availability of these results throughout your organization. Empower 3 EDM provides automated
project archiving capabilities to manage you data footprint. With advanced archive logic that
adapts to your business practices, Empower 3 EDM enables automated scheduling of the project
archive and verification prior to project deletion. In addition, Empower 3 EDM easily provides full
traceability and enhanced search functionality for all archived results. Fully configurable,
Empower EDM scales from a single lab to the global enterprise without major modifications to
your existing IT infrastructure.
For the laboratory staff, Empower EDM provides scientists the ability to view electronic reports
via a web browser years after the data or report was compiled, enabling them to leverage past and
future analysis. Designed to balance the need for long-term record retention with the scientist’s
need for access to data, Empower EDM enables scientists to view information on virtually any
computer regardless of the software, operating system or hardware—essentially future-proofing
archived data.
Method Validation Manager Option
Method Validation Manager is an Empower 3 software enterprise option that simplifies the
validation of your chromatographic methods. This option incorporates corporate method
validation requirements into reusable templates that adhere to corporate SOPs. Method Validation
Manager completely performs and manages the workflow from acquisition through data
processing and reporting in Empower. The software tracks the status of each validation test and
performs automatic data checks of raw and processed data to ensure the proper raw and processed
data is used throughout the workflow. Acceptance criteria flag results that fail. Data approvals
provide a ‘gatekeeper’ in the workflow to keep a historically error-prone process error-free.
Method Validation Manager will allow users to make calculations and produce reports for the
following parameters: Specificity , Linearity, Accuracy, Repeatability, Intermediate Precision,
Reproducibility, Robustness, Limit of Detection (LOD)/Limit of Quantitation (LOQ), Filter
Validation and Stability. This option provides an enhanced interface to create validation methods
and process and view validation results as well as additional reporting capability, to allow users to
report validation information.

Function
The Method Validation Manager option implements a workflow solution to
Build
2154 FR3
3
method validation activities in Empower Software. It allows users to specify
validation requirements in a method template format which can then be used in
a Validation Study where the data can be acquired and processed, viewed,
approved, checked, managed, and reported.
The following Validation Tests can be performed using an MVM protocol 2154 FR3
method:
• Linearity (of the Response)
• Linearity Comparison
• Accuracy
• Repeatability
• Intermediate Precision
• Intermediate Precision (DOE)
• Reproducibility
• Robustness
• Limit of Detection
• Limit of Quantitation
• System Precision
• Specificity
• Filter Validation
• Stability
The MVM option includes the Validation Manager application (window) 2154 FR3
which is used to manage validation data, a Validation Review application
(window) that allows you to view validation data in plots and tables, and
additional reporting capability, to allow users to efficiently report validation
information.
MVM provides a workflow based validation solution based on three 2154 FR3
hierarchical levels-- Compound Type (API, Drug product), Analytical Method
Type (Assay, Impurities, Content Uniformity, etc), and Development Phase
(Phase I, Phase II and Phase III).
MVM provides customizable nomenclature through the use of built-in custom 2154 FR3
fields and default strings.
MVM allows the use of a variety of experimental designs during data 2154 FR3
acquisition and processing in order to provide comprehensive information
while minimizing the number of required chromatographic injections.
MVM allows data acquisition to be performed using validation sample 2154 FR3
composites--each injection may be used for multiple validation tests-- linearity,
accuracy and repeatability, for example.
MVM performs data checks to ensure that the set of injections for each 2154 FR3
validation test adheres to the validation protocol parameters; i.e. correct
number of data points, levels, replicates, etc.
MVM automatically calculates a complete set of structurally validated 2154 FR3
calculations.
MVM automatically performs comprehensive statistical analysis of the 2154 FR3
validation results.
MVM allows validation of multiple components within samples. 2154 FR3
MVM alerts users to results that are out of specification (OOS). 2154 FR3
MVM Stores data within Empower’s database for complete data security, data 2154 FR3
traceability and data mining capabilities.
MVM allows data to be approved or signed off at various steps in the method 2154 FR3

validation workflow.
MVM displays the status of an ongoing validation study so the user can easily
see where each validation test is in the workflow—what activities have already
2154 FR3 3
been done, what needs to be done next, and when each test is complete.
MVM provides all necessary tools to interact with data—view data and results, 2154 FR3
acquire data, process data, approve data, check data, and preview data.
MVM allows viewing of data in both graphical and tabular formats. Tables 2154 FR3
and plots are customizable and interactive.
MVM provides user permissions and security in order to grant users 2154 FR3
appropriate access to data and activities within the software.
MVM provides report groups and report templates specific for method 2154 FR3
validation data.
MVM activity is audit trailed. 2154 FR3
MVM allows multiple sample preparations and injections to be acquired and 2154 FR3
used to create validation results.
MVM calculates %RF, as well as RF (Response Factor). 2154 FR3
The Intermediate Precision test includes additional fields in the Supportable 2154 FR3
Estimation Table.
Accuracy Total Error calculations are available in the Accuracy Test. Empower 3
The Linearity of the Method validation test is available. Empower 3
Qualification Products
Function Build
Waters Qualification Tools (SystemsQT) – for performing a Performance 2154 FR4
Qualification (PQ)
The SystemsQT option lets Waters personnel qualify chromatographic systems
within a defined workflow. This option consists of an Empower wizard and an
associated system-specific Empower project. The Empower SystemsQT
Wizard, which is available in Run Samples, streamlines the process of test
selection, updating standard concentration and chemistry, selecting custom
field calculations, and loading the sample sets in a defined order. The
Empower project contains all the required methods, reports, and custom fields
to perform the qualification.
Empower Software Automated Qualification Tool (AQT) and MVM AQT – 2154 FR3
for performing an Operational Qualification (OQ)
The SoftwareAQT option lets Waters personnel qualify Empower nodes. This
option consists of an Empower wizard and an associated Empower project.
The wizard automates the processing of the supplied, well-characterized data
set using either Traditional or ApexTrack integration and reports whether the
results are as expected. The MVM AQT processes validation test results and
reports whether the validation results are as expected.

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The application addresses a comprehensive range of corporate laboratory concerns:

1. Comprehensive Applications Support

2. Laboratory, Site and Enterprise Wide Information Management

3. Regulatory Compliance (GLP/GMP/ER/ES)

4. Maximizing Instrument and Application Availability

5. Minimizing System Downtime

6. Data Security, Change Control and Audit Trails

What Makes Empower 3 Unique?

5. Empower 3 Enterprise extends the capability of the Empower 3 Personal

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Multiple User Interfaces

3. QuickStart – simple, single window interface that optimizes access to available

Access and share information from Productivity is enhanced when information

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Security and Regulatory Compliance 1

Fully Secure Raw Data • Access to raw data is controlled by

• Raw data integrity algorithms assess

Information is stored remotely from On an Enterprise client/server system,

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Acquisition operations are isolated and The LAC/E32 Module can be

Processing operations are performed Processing is done on the client when

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Minimize downtime. With traditional data systems, if one

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Empower 3 Designed for the Enterprise

Empower 3 is a family of products or a technology, it is not just a piece of software. It comprises:

1. A base set of features (the application environment)

2. Available on industry standard platforms

3. A series of add-on applications from Waters to enhance functionality

4. The Empower Toolkit (Software Development Kit) for custom applications;

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Empower Scalability Strategy

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Extending Empower 3 Workgroup creates an Enterprise system, which is a full-scale client/server

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Empower 3 is truly designed for the enterprise.

Enterprise Authentication Using Active Directory (LDAP)

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Named User Licenses

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Client/Server and Workstation Specific Licenses

These licenses must be uninstalled if the software is to be reloaded.

Options Not Requiring Licenses

A system is defined by Waters as a group of chromatographic instruments that are used

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The Waters Service

Once the Waters Service is enabled:

Data Acquisition and Buffering

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How Oracle and Server Failures are Recognized

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Local Directory and File Organization

How Identifiers are Assigned

Empower 3 and Date Handling

How Empower 3 Handles Dates

Oracle Date Format

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Where Do The Dates Come From?

Item Normal Operation Buffering Mode Note