All "21 Cfr Part 11" articles

A comprehensive review of the best 21 CFR Part 11 software in 2024

There are multiple 21 CFR Part 11 software providers that can help you meet the requirements of the FDA's electronic record regulations. But a ...

21 CFR Part 11: Compliance in the supply chain [Checklist]

21 CFR Part 11 applies to any official quality or manufacturing records pertaining to the design, development, or manufacture of a drug or device ...