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SOLUTIONS
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Alarm Management |
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<- Back to Pharmaceuticals and
Biotechnology
<- Back to Alarm Management Solutions 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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