Remaining in a 21 CFR Part 11 Compliant State

This article provides practical advice for remaining in compliance with 21 CFR Part 11, the Electronic Records; Electronic Signatures Final Rule.1 It is directed at those who are responsible for maintaining this compliance. And just how do we do this? Descartes, in his Discours de la Methode, provided a clue when he wrote, “Each problem that I solved became a rule which served afterwards to solve other problems.” For our purpose, this translates to: remember how we got here and make sure we keep the momentum going.

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