Agile PLM

FDA 21 CFR Part 11 Compliance: Dual Identification for Signoffs

By Anurag Batra on October 20, 2008 8:23 AM

Here's an extract from the Federal Register that lays out the final ruling of 21 CFR Part 11: "Section 11.200 provides that electronic signatures not based on biometrics must employ at least two distinct identification components such as an identification...

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Storing outbound compliance information in PGC

By shankar.muthan on September 22, 2008 8:00 AM

You obviously know that you can use a Declaration to gather compliance information from your suppliers. Those are inbound Declarations where the data is submitted by Suppliers or content providers. But, did you know you can also use a Declaration...

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