Dual databases secure audit trail

Published: 30-Jun-2001


From the producer of RAPID (Realtime Access Process Information Database) comes RAPID-Pharma, which is aimed at companies that need to comply with the FDA 21 CFR Part 11 standard for Electronic Records and Electronic Signatures.

Automsoft's RAPID-Pharma is the first plant information management system to offer out-of-the-box compliance with the specification. It enables companies to keep complete audit trails of their electronic records in a highly secure dual database system. The package stores all the process and batch record data in one secure database.

A complete audit trail of all human interactions with batch production records is maintained in a separate Audit Database. This may reside on the same hardware or on a separate system.

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