FDA 21 CFR Part 11 Compliance

Compliance with U.S. Food and Drug Administration (FDA) 21 CFR Part 11 is essential for regulated companies using electronic records and signatures.

With 21 CFR Part 11, the FDA ushered in the use of modernized technology for records and submissions. The regulation made electronic records and signatures as valid as paper records and handwritten signatures. Part 11 does not mandate the use of electronic systems. Rather, it specifies the requirements for companies that choose to use digitized systems in their compliance efforts.

21 CFR Part 11 Industry Overview: Ready for an FDA Inspection?