Nymi Blog Why FDA Title 21 CFR Part 11 matters more than ever - Part 2

Title 21 CFR Part 11 has added much-needed clarity to how companies need to approach Electronic Record Electronic Signature (ERES)  (to catch up on the history of the rule, click here.) Knowing what the rule entails is essential, but even more important is understanding how Part 11 impacts the day-to-day operation of a manufacturer.