SIMCA-P+ compliant with 21 CFR part 11 (Q670)
The information in this article applies to:
- SIMCA-P+ 12
- SIMCA-P+ 12.0.1
Summary
To make SIMCA-P+ compliant with 21 CFR part 11, the Audit trail has to be turned on.
More Information
An administrator can force the Audit trail to always be turned on. Linked to this article are registry entry-files that makes this procedure convenient for the administrator. The linked .zip-file contains a readme.txt-file with more information concerning the registry entry-files, the registry entry-files, and the document "Audit trail in SIMCA-P+" for more information concerning the Audit trail. See also About the Audit Trail - Compliance with 21 CFR part 11 (Q669).
External Document
/download/KB/AuditTrailSIMCA-P12.zip
Date modified: apr 23, 2010
Article type: Information
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