FDA 21 CFR Part 11: Electronic Records and Electronic Signatures

What this entry covers

21 CFR Part 11 is the FDA regulation that sets the criteria under which FDA treats electronic records and electronic signatures as trustworthy, reliable and generally equivalent to paper records and handwritten signatures. It applies to records that FDA-regulated organizations keep or submit under FDA requirements. FDA’s 2003 final guidance, Part 11, Electronic Records; Electronic Signatures: Scope and Application, explains how FDA interprets and enforces the rule.

MyRHC indexes this framework so practitioners, auditors, and automated agents can find the authoritative primary sources in one place. This page is a navigation aid. It is not legal advice and is not a substitute for the official text.

Official documentation

• Primary official source: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application
• FDA, Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers (October 2024): https://www.fda.gov/regulatory-information/search-fda-guidance-documents/electronic-systems-electronic-records-and-electronic-signatures-clinical-investigations-questions

Recent changes

• 2024-10-02: FDA announced the final guidance Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers, covering the use of electronic systems, records and signatures in clinical investigations. Federal Register 2024-22562

How to use this index entry

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