FDA 21 CFR Part 11 Compliance and Checklist
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 modernised 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 digitised systems in their compliance efforts.
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