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Pharmaceuticals and Biotechnology
21CFR Part 11
The FDA's 21CFR Part 11 regulation enforces electronic signature
and data integrity requirements. 21CFR Part 11 is intended to protect
production records from unauthorized changes and to ensure an auditable
record of any changes that were made. LogMate is used as an alarm
and event historian within the human sciences industries. As a priority,
LogMate was designed to integrate with and augment 21CFR Part 11
compliance efforts.
The LogMate Capture data collection module and the Microsoft®
SQL Server® database component work in concert to form a 21CFR Part
11 solution. Capture collects alarm and event data from the plant
and sends it to SQL Server. As such, modifications of Capture settings
can affect the data stored in the database. Capture includes an
integrated change audit feature that requires authorization for
and records changes to Capture settings, which prevents unauthorized
modification of the Capture environment.
Microsoft SQL Server is an extremely robust, highly secure database
engine. A strong security policy protects archived data from manipulation.
As a rule, SQL records any database modification, by a user or a
program, into a continuous transaction log. Through these mechanisms,
SQL Server meets the electronic signature and audit trail requirements
of 21CFR Part 11. LogMate Capture is designed to seamlessly interact
with the most secure SQL environment without compromising the regulatory
infrastructure.
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