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Empower Software Functionality

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Empower 3 Build 3471

April, 2011

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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

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Processing Server

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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

General Functionality

36

Project Window

37

General Functionality

37

Views

39

View Filters

40

Tools

41

Alter Sample

42

Compare

43

Import / Export

43

Run Samples

44

General Functionality

45

Run Samples Toolbar

46

Sample Loading Table

46

Processing

48

General Functionality

48

Derived Channels

51

General Functionality

51

Review Window

51

General Functionality

52

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

General Functionality

63

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

General Functionality

70

QuickStart Interface

70

General Functionality

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

General Functionality

78

Qualification Products

79

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Section 1 - Introduction

Empower 3 Functionality

1

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

7. Customization and Interaction with 3 rd Party Applications

What Makes Empower 3 Unique?

The unique properties of the Empower 3 application include:

1. Empower 3 (As well as Empower and Millennium 32 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.

2. Empower 3 (As well as Empower and Millennium 32 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.

3. Empower 3 (As well as Empower and Millennium 32 software) is the only data system 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.

4. Empower 3 (As well as Empower and Millennium 32 software) is the only data system 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.

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Multiple User Interfaces

Empower 3 Functionality

The Empower 3 Software allows the user to choose the software interface that is appropriate for their individual requirements.

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1. Pro – provides a look and feel that is similar to Millennium 32 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 clients running the Empower 3 application.

Minimizes system management and simpler data archival. Each system management task needs to be done only once.

One central location for all chromatography information

The user can create combined summary 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 multiple instruments, laboratories and sites easily.

Productivity is enhanced when information can be shared easily. Laboratories can pass 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 (GLP/GMP/ER/ES)

All method information and raw data is 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 appropriate and convenient for the user.

Access any information on the system from any client computer. Work can be done where it is most convenient. Laboratory space can be utilized for instruments without needing to use valuable bench space for computers/clients.

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Security and Regulatory Compliance

1

Features

Benefits

Empower 3 user levels and logon security.

Ensures that only valid users are able to access the system and that each user can do only what they should be allowed to do.

Electronic Record (ER) and Electronic Signature (ES) compliant-ready

Full compliance with the ER/ES rule of the FDA (21 CRF Part 11) ensures that pharmaceutical laboratories can meet their obligations to the regulatory authorities.

Fully Secure Sample, Method and Result information

All information (excluding the raw data) 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 the user

On an Enterprise client/server system, 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.

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Empower 3 Functionality

Component-Based Architecture

1

Features

Benefits

Application load is balanced between hardware components.

Traditional workstation or LAN-based 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 optimized on the server.

The server can be configured to allow 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 optimized on the LAC/E 32 Module.

The LAC/E 32 Module can be 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/E 32 Module than can be run on a client, minimizing the cost of acquisition.

Processing operations are performed where it is most appropriate.

Processing is done on the client when 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/E 32 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.

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Scalable Architecture

Empower 3 Functionality

1

Features

Benefits

Scale up seamlessly from Personal workstation to Enterprise client/server.

Using the component-based architecture 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.

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Empower 3 Designed for the Enterprise

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Empower 3 is an information management strategy for chromatography data.

an information management strategy for chromatography data. Empower 3 is a family of products or a

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

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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 of configurations to meet different business needs.

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Acquisition & Control Database Processing & Reporting
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.

diagrams are abbreviated to a single letter, P =Processing, D =Database and A =Acquisition. 1- 7
diagrams are abbreviated to a single letter, P =Processing, D =Database and A =Acquisition. 1- 7
diagrams are abbreviated to a single letter, P =Processing, D =Database and A =Acquisition. 1- 7
diagrams are abbreviated to a single letter, P =Processing, D =Database and A =Acquisition. 1- 7

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Empower 3 Functionality

1

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.

and the software due to the limited number of keyboards. So, what can be done? Must
and the software due to the limited number of keyboards. So, what can be done? Must
and the software due to the limited number of keyboards. So, what can be done? Must
and the software due to the limited number of keyboards. So, what can be done? Must
and the software due to the limited number of keyboards. So, what can be done? Must
and the software due to the limited number of keyboards. So, what can be done? Must

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.

work to do data reduction. This adds more keyboards without the cost of the acquisition component.
work to do data reduction. This adds more keyboards without the cost of the acquisition component.
work to do data reduction. This adds more keyboards without the cost of the acquisition component.
work to do data reduction. This adds more keyboards without the cost of the acquisition component.

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work to do data reduction. This adds more keyboards without the cost of the acquisition component.

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Empower 3 Functionality

1

The problem has always been ‘how does the data get to the processing station’? This not only meant that 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/E 32 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.

where the laboratory already has one or more workstations. Empower 3 Workgroup provides a true multi-user,
where the laboratory already has one or more workstations. Empower 3 Workgroup provides a true multi-user,
where the laboratory already has one or more workstations. Empower 3 Workgroup provides a true multi-user,
where the laboratory already has one or more workstations. Empower 3 Workgroup provides a true multi-user,
where the laboratory already has one or more workstations. Empower 3 Workgroup provides a true multi-user,
where the laboratory already has one or more workstations. Empower 3 Workgroup provides a true multi-user,
where the laboratory already has one or more workstations. Empower 3 Workgroup provides a true multi-user,
where the laboratory already has one or more workstations. Empower 3 Workgroup provides a true multi-user,
where the laboratory already has one or more workstations. Empower 3 Workgroup provides a true multi-user,

Empower 3 Workgroup provides a true multi-user, multi-keyboard solution with the LAC/E 32 Module as the ‘hub of the wheel’. It is important that the LAC/E 32 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.

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Empower 3 Functionality

1 LAC/E 32 Extending Empower 3 Workgroup creates an Enterprise system, which is a full-scale
1
LAC/E 32
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.

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Empower 3 Functionality 1
Empower 3 Functionality
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Empower 3 Functionality

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So, no matter how a laboratory needs to grow, there is an Empower 3 configuration that will fit your needs. 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/E 32 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

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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

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Empower 3 Functionality

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.

Millennium 32 , 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/E 32 Module in a Workgroup or Enterprise configuration. Only online

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system must have a license. The number of online systems cannot exceed the number of System Control Licenses activated within the Empower 3 environment.

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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/E 32 Module configurations and two System Control Licenses are integrated into the Dual LAC/E 32 Module configurations. System Licenses are also available for purchase separate from LAC/E 32 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/E 32 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.

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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 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”.

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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”.

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Local Directory and File Organization

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The Oracle destined data is kept in a file named SampSetxxxx.dat where xxxx is a number corresponding

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

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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.

Microsoft Date Format

2

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/E 32 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 (DXXXX.DAT)

Server

Server

3

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.

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Empower 3 Use of Oracle Tablespaces

2

Empower 3 Software contains an Oracle database, which is fully integrated into the application. This 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

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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 can be managed via the Oracle Enterprise Manager (OEM) storage management console

2

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:

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Empower 3 Functionality Empower 3 Executables Processing Server Acquisition Server Oracle Database Server Oracle TNS
Empower 3 Functionality
Empower 3 Executables
Processing Server
Acquisition Server
Oracle Database Server
Oracle TNS Listener
Oracle
Windows Operating System
TCP/IP
Network Interface Card

2

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:

Empower 3 Executables Processing Server Acquisition Server Oracle Database Server Oracle Database Server Oracle TNS
Empower 3 Executables
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).

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Empower 3 Functionality Empower 3 Executables Processing Server Acquisition Server Oracle Database Server Oracle
Empower 3 Functionality
Empower 3 Executables
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

2

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

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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 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)

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Section 3 – Functionality

Empower 3 Functionality Version 4.0

3

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

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General

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 LACE 32 Modules (a network device dedicated to chromatographic instrument control and data acquisition) that can be configured and used. Each LACE 32 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 Millennium 32 and will therefore be familiar to Millennium 32 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

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Using Empower software, you can:

1154

Acquire data and control chromatographic instrumentation Process data interactively or in the background Customize management of project information Customize report design and generation

Using Empower software you can easily perform simple acquisition and processing requirements such as:

1154

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 lifecycle (SDLC).

1154

Empower Software is ISO 9001 TickIT certified.

1154

Comprehensive, context-sensitive Windows online help is supplied with the Empower application.

1154

Waters maintains all development documentation, including Requirements, Functional Specifications, Source Code, Test Protocols and other information related to product life cycle.

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Source code for each version of Empower is available in an Escrow Account.

1154

Automated qualification is available for Empower workstations, clients and acquisition servers.

1154

Custom programs that interact with or control Empower may be written using the Empower Toolkit. The Toolkit is a programming interface to Empower functionality.

1154

Multiple Toolkit applications may be run at the same time to accomplish different tasks.

1154

The Toolkit supports any programming language that supports Microsoft standards such as ActiveX and COM (for example: Visual Basic, VBA, Visual C++ etc.).

1154

The Toolkit allows applications to be configured into the Empower user interface by adding menu items to various Empower windows as required.

1154

As a product, the Empower LIMS Interface provides a seamless interface to LIMS systems. Specific LIMS systems/formats supported include:

1154

ASCII AIA (ANDI) PE SQL*LIMS LabSystems LabManager LIMS

The Empower LIMS interface is no longer offered as a product, but is made available as an example program in the Empower Toolkit Option

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Report/Preview can be launched with a specified report. The Project object Launch Mil App Method has an argument allowing the programmer to specify a report method.

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FR3

Toolkit allows access to the “Next Service Due” field using a new object. This allows a Toolkit user to modify this field as required.

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FR3

Toolkit allows access to Injections.

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FR3

Toolkit now allows access to Custom fields.

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FR3

View Filters (including new Method Validation Manager view filters and 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.

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FR3

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Installation, Configuration and System Management

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/E 32 Modules.

1154

The display of information can be customized with default or user-defined view filters to determine the fields, criteria, and the order in which data is displayed.

1154

Configuration actions allow the use of standard drag-and-drop, display, selection, and cut-and-paste code functions.

1154

Configuration information is displayed in tabular format. Table columns can be sorted in ascending and descending order and tables can be printed.

1154

All Empower objects selected may be deleted via a ‘Yes to All’ button added to the delete warning dialog, or the user will have the choice of deleting each object selected ‘Yes’ or ‘No’, or they may ‘Cancel’ all together.

1154

Preferences can be copied between users and projects on a per-user and per-project basis. Preferences can be copied during project creation or using the View > Copy Preferences menu in Configuration Manager.

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The ConnectionsAQT option (if present) is available from Configuration Manager.

1154

The System Monitor application is available from Configuration Manager.

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Allow entry of serial number during installation of software options.

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Export/Import of Systems Objects:

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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)

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> User Types (incl: privileges)

 

> Systems (incl: instrument info, access)

> Acquisition Servers (incl: instrument info, serial ports, access)

Max Rows in the table view of the Configuration Manager or Project window: set 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.

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Ability to import legacy MassLynx MS/MS data

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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 Empower.

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FR5

Projects

3

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 appropriate privilege.

1154

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 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.

1154

During backup, the version of software in which the project was backed up is tracked. Upon restore, the version from the backup is documented in the System Audit Trail entry.

1154

Empower does not require a specific backup utility but the user has the option to configure a backup utility into the backup process.

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Project backup will take all information within a project and place it in a specified location.

1154

Project restore will take all information from a backup set and restore the project to the state at which it was at the time of backup.

1154

Projects may only be deleted from the Empower database by a user who has the “Delete Project” privilege.

1154

Audit trail settings must be configured when a project is created. These settings cannot be altered after creation is complete.

1154

When a new project is created, the maximum size a project is allowed to grow to must be specified.

1154

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Access to a project may be limited to the project owner, a specified set of user groups or the project may be available to all users.

1154

If

access to a project is given to a group or to all users, the access can be limited to

1154

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 and/or views can be copied from another, template project.

1154

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 Project Wizard – Options page.

1154

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 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.

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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 batch Project Backup or Restore. A log file is generated to document these errors.

Empower

3

Users

3

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

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User accounts may be set to one of the following three status conditions:

1154

 

Active

Disabled

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.

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There is no limit to the number of users that can be created provided that an adequate number of user licenses have been installed.

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Allowed software user interfaces (QuickStart, Pro, Open Access, Web, and System Default) can be defined for each user.

1154

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

3

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 servers.

1154

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

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When an acquisition server is defined, access to that acquisition server may be given to the system owner only, to the owner and selected user groups or to all users.

1154

Up to 4 computer serial (COM) ports may be used to connect instruments to an acquisition server.

1154

Up to 8 serial ports on an 8-Port Serial Card may be used to connect instruments to an acquisition server.

1154

An acquisition server may be password protected to prevent unauthorized reconfiguration.

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An acquisition server can connect to a chromatographic instrument using IEEE or serial connection (depending on the device).

1154

IEEE instrument connection is done using the Waters busLAC/E card.

1154

You can control up to four simultaneously online chromatographic systems in an Empower Personal workstation or a Workgroup/Enterprise acquisition client or LAC/E 32 Module. You can control up to eight simultaneously online chromatographic systems when using a LAC/E 32 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.

1154

Acquisition Servers are now called Empower Nodes. Citrix clients appear as Empower Nodes.

2154

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

3

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 Empower system.

1154

There are no limits to the number of chromatographic systems that can be configured in Empower software.

1154

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 currently be actively configured to run samples or may be systems that are not currently connected and powered on an Empower acquisition server.

1154

A System cannot be taken ‘Off-Line’ if any users are currently connected to it or if the system is currently acquiring samples.

1154

A System cannot be brought ‘On-Line’ if any of the components in the system are currently configured in another ‘On-Line’ system or if any component is not currently available.

1154

When a chromatographic system is defined, access to that acquisition server may be given to the system owner only, to the owner and selected user groups or to all users.

1154

Chromatographic systems may be password protected to prevent unauthorized access.

1154

Empower controls the following Waters HPLC pumps and solvent management systems:

1154

501(PCM/PCM II)

510(PCM/PCM II)

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Empower 3 Functionality

515(PCM/PCM II)

 

525 (PCM/PCM II)

600

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 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.

1154

Column temperature may be controlled through the use of integrated column 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).

1154

More than one detector may be configured in a single chromatography system. These detectors will use the same time base, and will be related to each other through their injection ID.

1154

Multiple detector channels from the same injection may be processed as a unit, 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.

1154

Data acquisition rates available are 0.25, 1, 2, 5, 10, 20, 25, 50, or 100 data points per second, depending on detector capabilities.

1154

Controlled instruments with digital data collection can handle the full dynamic 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.

1154

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

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Empower 3 Functionality

Instrument support in Empower 2 – please refer to the Empower 2 FR5 Installation and Configuration Guide

2154 FR5

Instrument support discontinued as of Empower 2:

2154

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 Configuration Guide

Empower

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

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Waters Corporation

3

Default Strings

Empower 3 Functionality

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 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.

3

Function

Build

Default strings can be created to minimize the typing required in the following sections of the Empower application:

1154

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 option to type a response that is not available in the default string list.

1154

The default string drop down list is initially blank (to prevent the user from simply clicking OK to accept the default).

1154

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 Empower application.

1154

Privileges are sufficiently granular to ensure that object (item) creation, modification and deletion can be set separately.

1154

Privileges are based on functions that can be performed and not on user interface elements of the software. This minimizes the complexity of configuration.

1154

Privilege settings are not required based on operating system settings or disk structures.

1154

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 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.

1154

The “Remove Sample Archives” specifies that a user can archive and remove project/sample records in binary or text format.

1154

The “View Audit Trails” privilege allows a user to view the System Audit Trail,

1154

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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 Audit Trail.

1154

The “Clear/Restore Offline Audit Trails” privilege specifies that a user can remove and/or restore archived System Audit Trail records from a binary file format. Records cannot be restored from a text file format.

1154

The “Clear/Restore Offline Archives” privilege specifies that a user can remove and/or restore all entries from the offline project and sample archives.

1154

The “Restore Archives” privilege specifies that a user can restore projects that have been backed up using the AutoArchive utility.

1154

The “Paste Shallow Copies” privilege specifies that a user can paste shallow copied 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.

1154

The “Lock Channels” and “Unlock Channels” privileges specify that a user can lock data channels, and/or unlock data channels, in the Project window.

1154

The “Alter Custom Fields”, “Create Custom Field” and “Delete Custom Field” privileges specify that a user can modify, create and/or delete a custom field in the Empower database.

1154

The “Alter Default Strings”, “Create Default Strings” and “Delete Default Strings” privileges specify that a user can modify, create, and/or delete default strings in the Empower database.

1154

The “Alter Plate Type”, “Create Plate Type” and “Delete Plate Type” privileges specify that a user can modify, create, and/or delete plate types in the Empower database.

1154

The “Alter System Policies” privilege specifies that a user can alter system policies in the Empower database.

1154

The “Alter Projects”, “Create Projects” and “Delete Projects” privileges allow a user to modify all properties (name, quota, access, custom fields, and so on) of a project, create

1154

a

project or delete a project from the Empower database.

The “Backup Projects” and “Restore Projects” privileges allow a user to archive and/or restore a previously archived project.

1154

The “Change Project Owner” privilege specifies that a user can change the owner of a project in the Empower database.

1154

The “Change Project Quota” privilege specifies that a user has a restricted form of the Alter Projects privilege, allowing the user to change only the database tablespace quota of a project to which the user has access.

1154

The “Create Project Path” privilege specifies whether the user has access to 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.

1154

The “Change Project Path” privilege allows the user to specify a project path other than the default when modifying a project. The new data path is defined in the Move Project Data dialog box.

1154

The “Specify Project Path” privilege allows the user to specify a project path other 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.

1154

The “View Multiple Projects” privilege specifies that a user can open and view multiple projects in a single Project window.

1154

The “Alter Users”, “Create Users” and “Delete Users” privileges specify that a user can change the properties of another user, create a new user or permanently remove

1154

a

user from the Empower database.

The “Alter User Type”, “Create User Type” and “Delete User Type” privileges

1154

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Empower 3 Functionality

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.

 

The “Alter User Groups”, “Create User Groups” and “Delete User Groups” 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.

1154

The “Delete Calibration Curves” and “Save Calibration Curves” privileges specify that a user can permanently remove from and/or save a calibration curve to the Empower database.

1154

The “Delete Data” privilege specifies that a user can permanently remove chromatographic data, such as injections, channels, and so on, from a project.

1154

The “Export Data” and “Import Data” privileges specify that a user can export data to and/or import data from a folder or device in a specified format.

1154

The “Delete Libraries” and “Save Libraries” privileges specify that a user can permanently remove and/or create and modify libraries in the Empower database.

1154

The “Rename Libraries” privilege specifies whether the user can change the name of a PDA or MS library.

1154

The “Delete Export Methods” and “Save Export Methods” privileges specify that a user can permanently remove and /or can save methods used to export data to another application.

1154

The “Delete Instrument Methods” and “Save Instrument Methods” privileges specify that a user can permanently remove and/or save instrument methods used for data acquisition.

1154

The “Delete Locked Methods” privilege specifies that a user can permanently remove from the Empower database any methods (locked or unlocked).

1154

The “Lock Methods” privilege specifies that a user can lock any methods in the Empower database. Once you lock a method, you cannot unlock or modify it.

1154

The “Delete Processing Methods” and “Save Processing Methods” privileges specify that a user can permanently remove and/or save processing methods used for data reduction.

1154

The “Delete Reporting Methods” and “Save Reporting Methods” privileges specify that a user can permanently remove and/or save report methods used to report or preview results.

1154

The “Modify Report Scaling Only” privilege specifies that the user has the ability to edit the Scaling tab for plots that are part of a method (including locked methods) for printing or previewing.

1154

The “Modify Default Report Methods” privilege specifies that the user has the ability to customize default report methods using the Edit > Manage Defaults menu in the Report Publisher.

1154

The “Modify Default Report Groups” privilege specifies that the user has the ability to customize default report groups using the Edit > Manage Defaults menu in the Report Publisher.

1154

The “Clear Read Only Methods” privilege specifies that a user can clear a method's read-only status while another user is editing the method.

1154

The “Save Methods as Current” privilege specifies that a user can save an earlier version of a method as the current version.

1154

The “Delete Sample Set Methods” and “Save Sample Set Methods” privileges 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.

1154

The “Delete Sample Set Method Templates” and “Save Sample Set Method 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.

1154

The “Delete Method Sets” and “Save Method Sets” privileges specify that a user can permanently remove and/or save method sets used to define a collection of

1154

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Waters Corporation

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Empower 3 Functionality

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 remove the 3D data associated with a PDA or MS data channel.

1154

The “Modify Integration Parameters” privilege allows the user to open existing processing methods and make changes to the integration parameters and integration events in the Integration tab of the method.

1154

The “Modify Component Parameters” privilege allows the user to open existing processing methods and make changes to the following component parameters:

1154

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 one project into another project.

1154

The “Delete Results” and “Save Results” privileges specify that a user can permanently remove from and/or save results in the Empower 3 database.

1154

The “Sign Off Results 1” and “Sign Off Results 2” privileges specify that a user can fill in the respective sign-off field in a result.

1154

The “Specify Report Methods for Sign Off” privilege specifies that a user can indicate which report methods are required for signoff.

1154

The “Alter Sample” privilege specifies that a user can change information about the contents of a vial after an injection from that vial has been made.

1154

The “Save View Filters” privilege specifies that a user can save view filters created in the Project window.

1154

The “Make View Filters Public” privilege specifies that a user can create or change the access type of a view filter to make it public or private.

1154

The “Acquire Samples” privilege specifies that a user can acquire data from a sample set method in Run Samples.

1154

The “Edit Sample Sets” privilege specifies that a user can modify existing sample set methods in Run Samples or in the Sample Set Method Editor.

1154

The “Reinject Samples” privilege specifies that a user can reinject individual samples or sample set methods that have been previously acquired in Run Samples.

1154

The “Allow Interactive Sys Changes” privilege specifies that a user can interactively change pump parameters in Run Samples.

1154

The “Alter Running Sample Sets” privilege specifies that a user can modify a sample set method while it is being acquired in Run Samples.

1154

The “Access Real time Plot from Open Access” privilege specifies that the user can access the Real Time Plot from Open Access.

1154

The “Alter Any Queue” privilege specifies that a user can rearrange any jobs in the Sample Sets table queue in Run Samples.

1154

The “Alter My Queue” privilege specifies that a user can rearrange his/her jobs in the Sample Sets table queue in Run Samples.

1154

The “Warn on Service Limit” privilege specifies that, if a user tries to use Run 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.

1154

The “Use Wizard Templates” privilege specifies that a user can create a sample set method from a sample set method template (which you create using the Sample Set Method wizard).

1154

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Empower 3 Functionality

The “Allow Remote LAC/E Reboot” privilege specifies that the user can remotely reboot a LAC/E 32 Module from Configuration Manager.

1154

Allow shallow copy of methods between Full Audit Trail projects (Management tab)

2154

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, % Height, Amount, % Amount, Response, and Concentration

2154

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 Saving)

2154

View Quantitation Peak Fields in Review (Management tab) allows control over viewing the following fields in Review:

2154

Area,

% Area,

Height,

% Height,

Amount,

% Amount,

Response

Concentration

Allow Calibration and Quantitation in Review (Management tab) allows users to 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:

2154

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 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:

2154

Component tab: In the Component table, the 7 CConst fields

Default Amount tab: In the Default Amount table, the component values

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Empower 3 Functionality

 

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 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 to determine if such a data file can be used.

2154

View Quantitation Peak Fields in Review (Management tab). Show the following 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.

2154

Allow Calibration and Quantitation in Review (Management tab). Calibrate and 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.

2154

Modify Report Scaling Only (Method tab). Edit the Scaling tab for plots, and then preview/print the report from Report Publisher. The scaling change displays in the report method and is recorded in the project audit trail.

2154

Access Real Time Review from Run Samples (Data Acquisition tab). The privilege will be used to enable/disable the real time review button on the Run Samples toolbar.

2154

Delete Tune Methods and Save Tune Methods (Methods tab)

2154

Delete MS Calibration Methods and Save MS Calibration Methods privileges (Methods tab)

2154

The “Validation Administrator” privilege enables All method validation privileges and the lock method privilege. These privileges are automatically turned on and cannot be turned off. The Validation Administrator can also perform these tasks:

2154

FR3

 

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 can change the project type (standard, validation working, validation template).

2154

FR3

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 validation protocol method in the database.

2154

FR3

The “Delete Validation Studies” privilege specifies that a user can delete a validation study and all associated validation results from the database.

2154

FR3

The “Save Validation Studies” privilege specifies that a user can Create a new validation study, attach sample set methods, sample sets, and result sets to a validation study, and create validation results.

2154

FR3

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 Approve validation protocol methods that require approval.

2154

FR3

The “Approve Validation Study Data” privilege specifies that a user can Within a validation study, approve sample set methods, sample sets, and validation studies.

2154

FR5

The “Override Validation Data Checks” privilege specifies that a user can Override

2154

FR3

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Empower 3 Functionality

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 named table preferences to the database.

2154

FR5

The “Delete Named Table Preferences” privilege specifies that a user can delete named table preferences from the database.

2154

FR5

The “Manage Process Only Sample Sets” privilege specifies that a user can create Process Only Sample Sets. In order to delete Process Only Sample sets, a user must have both the Delete Data and Manage Process Sample Set privileges.

Empower

3

The “Delete eCord Columns” privilege specifies that a user can delete eCord column information from the Empower database.

Empower

3

The “View Message Center for All Users” privilege allows users to see messages in the Message Center for all users, or only messages of their own.

Empower

3

System Policies

3

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