Monday Oct 20, 2008

FDA 21 CFR Part 11 Compliance: Dual Identification for Signoffs

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 code and password". With Agile 9.2.2.2, we've provided an ability for Administrators to configure specific workflow statuses that require signoff to require an additional form of user authentication along with the usual approval password. The Administrator also has the flexibility of determining what the second form of user authentication should be. [Read More]
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