What 21 CFR Part 11 - Electronic Records; Electronic Signatures requires
This regulation establishes the criteria under which the U.S. Food and Drug Administration considers electronic records, electronic signatures, and…
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Pillar: Pharmaceuticals & Life Sciences · Authority: U.S. Food and Drug Administration · Version: 1.0.0 · Last updated:
Primary source: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11
SHA-256 integrity: d94e0e10b0073353769b4f1ea998694e173c3d5a788dd2ecda507f6b982e42d5
Primary Citations — 7 traced to source
- § 11.10 Controls for closed systems.
- § 11.30 Controls for open systems.
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Access
- Discovery (free): /api/v1/nodes/us-fda-cfr-21-part-11-electronic-records-signatures.json — 6-field metadata
- Vault (full node): /api/v1/vault/nodes/us-fda-cfr-21-part-11-electronic-records-signatures.json — full 13-key payload, $0.01 USDC (L402/Skyfire/Direct Base)
- Canonical URL: https://bidda.com/intelligence/us-fda-cfr-21-part-11-electronic-records-signatures
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