MasterControl Electronic Batch Records (EBR)

For pharmaceutical companies, accountability is an important component of quality management and FDA compliance. Batch records,
required by FDA Current Good Manufacturing Practice (CGMP) regulations, demonstrate accountability by providing proof of proper
handling for every step in the production of each batch of a drug product. In addition, manufacturers that execute and document batch
records electronically must comply with 21 CFR Part 11 requirements.

How Can MasterControl Software Solutions Help You?

MasterControl Process contains all the tools you need to create your electronic batch record forms, meeting all the requirements of
Part 11. Our experienced process consultants will lead you through project scoping, requirements gathering, implementation, testing,
validation, and go live activities to deliver to you a solution that truly meets your organizations needs.

Heres how MasterControl addresses some of the major challenges companies face with batch record systems.

Challenges MasterControl Solution

Inefficient Process: Batch operations conducted manually are
inherently slow, cumbersome, and error-prone. As regulations get
more complicated, batch records become exponentially larger
and more complex, taking more time to prepare and review.
Common snags to manual batch operations include: incorrect
data entry, failure to recognize out of spec entries, missing
signatures, filling out incorrect forms, sending forms to the wrong
recipient, and forms left incomplete.
Efficient Process: Batch record solutions developed on
MasterControl Process perform data integrity checks,
automate calculations, and enforce required actions such as the
initiation of an unplanned deviation. Automated routing ensures
that all steps are carried out in sequence and that no signatures
are missing, ever.

Poor Tracking: Physically tracking logs, test results, and other
records from different departments is time consuming. A manual
process makes it almost impossible to avoid bottlenecks, a
serious problem in case of a need to identify defective batches.
Automatic Tracking: MasterControl tracks all routing
information and data entered into the electronic form,
allowing the batch coordinator to follow the overall process,
identify bottlenecks, and understand the sequence of events
during processing.

Disconnected Processes: Under a paper-based or a partially
electronic batch record system, data may be kept in different
repositories that are disconnected, making reporting, trending,
and analysis difficult.
Connected Processes: MasterControl Process solutions
are part of the MasterControl integrated suite, allowing
connectivity with other applications that control different
quality processes. For example, production data can be
correlated to deviations, material nonconformances, and
customer complaints. Through its robust analytics capability,
MasterControl leverages all data collected by the system for
use in continuous quality improvement.

Features and Benefits:

MasterControl Process is the ideal platform for automating and optimizing management of batch records.

Complete Data Capture: All user entries are captured, electronically stored, and available for reporting. This includes loading
of external files, making them part of the batch record.

Data Integrity Checks: Each field can run automatic checks to ensure that the data entered is in the correct
format. Missing data, incorrect date formats or incorrect units of measure will never be a problem with
MasterControl Process.

Automated Calculations: Calculation logic ensures that each data item only has to be entered once and can feed
into calculations such as yield calculations or recipe amount calculations. Never worry about accuracy of calculations again.

MasterControl Electronic Batch Records (EBR)

 Performer/Witness Signoff: Each signature point can be configured for a single signature or Performer/Witness signatures.
Performer/Witness signature points allow two users to submit their signatures from a single
signoff window.

Parallel and Sequential Processing: Processing steps can be set up in a combination of sequential and parallel units.

Integrates with Deviations: Every manufacturing process needs a mechanism to deviate from the prescribed procedure,
but controls must be in place to ensure that a deviation is acceptable. MasterControl Deviations seamlessly integrates
the recording, assessment, and approval of a planned or unplanned deviation into the overall manufacturing process.
MasterControls EBR and Deviations solutions also link to other quality management modules such as MasterControl
Nonconformance and MasterControl CAPA.

Analytics Reporting Tool: This built-in tool comes with a standard set of pre-configured reports that can be customized
by the user. Production records can be trended and analyzed by product, recipe, process stage, etc. These data-mining
capabilities provide important insights into overall production activities such as turnaround, quality issue rates, etc.

Compliant System: As with all software developed by MasterControl, the solution is fully compliant with 21 CFR Part 11
regulations, providing time-stamped audit trails, reporting, and electronic signature capabilities. Security features include dual
passwords for document approval as well as password expiration, encryption, and certification.

Validation: MasterControl considers validation an integral part of solutions for FDA-regulated customers. Our continuous
validation approach dramatically cuts the time, effort, and cost of validation, making it easier to validate future upgrades.

About MasterControl
MasterControl Inc. produces software solutions that enable regulated companies to get their products to market faster, while reducing
overall costs and increasing internal efficiency. MasterControl securely manages a companys critical information throughout the
entire product lifecycle. Our software is known for being easy to implement, easy to validate and easy to use. MasterControl solutions
include quality management, document management/document control, product lifecycle management, audit management, training
management, bill of materials, supplier management, submissions management, and more. Supported by a comprehensive array of
services based on industry best practices, MasterControl provides our customers with a complete information management solution
across the entire enterprise. For more information about MasterControl,visit www.mastercontrol.com, or call: 1.800.825.9117 (U.S.);
+44 (0) 1256 325 949 (Europe); or +81 (03) 5422 6665 (Japan).

2015 MasterControl Inc. All rights reserved.

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MasterControl Electronic Batch Records (EBR)