What FDA 21 CFR Part 11 - Electronic Records and Electronic Signatures requires
21 CFR Part 11 establishes criteria under which the FDA considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and equivalent to paper records. It applies to all FDA-regulated activities including clinical trials, manufacturing, and laboratory records.
Pillar: Medical & Healthcare · Authority: U.S. Food and Drug Administration (FDA) · Version: 1.0.0 · Last updated:
Primary source: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11
SHA-256 integrity: 0d813127ff2148d327413a12df6da4327ab269cd6cb93fa6e5fba12c8cd32494
Primary Citations — 2 traced to source
- Code of Federal Regulations, Title 21, Part 11 - Electronic Records; Electronic Signatures
- FDA Guidance for Industry: Part 11, Electronic Records; Electronic Signatures - Scope and Application
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