What US FDA 21 CFR Part 11 - Electronic Records and Electronic Signatures in FDA-Regulated Industries requires
US FDA 21 CFR Part 11 establishes the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records and handwritten signatures for FDA-regulated activities…
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Pillar: Pharmaceuticals & Life Sciences · Authority: US Food and Drug Administration (FDA) · Version: 2.0.0 · Last updated:
Primary source: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11
SHA-256 integrity: 7e5e645ae974f90f717c17afcafa9fa268d9c0234ddf6436d250d532162638ac
Primary Citations — 8 traced to source
- https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11
- https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11
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- Discovery (free): /api/v1/nodes/us-fda-21-cfr-part-11-electronic-records-signatures.json — 6-field metadata
- Vault (full node): /api/v1/vault/nodes/us-fda-21-cfr-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-21-cfr-part-11-electronic-records-signatures
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