What 21 CFR Part 11 - Electronic Records; Electronic Signatures requires
This regulation outlines the scope, implementation, definitions, and controls for electronic…
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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: 54ba3c8c4d5cfc3eed7367a5774fc6f8937fdd3b1ded3749a07647ad91e6a517
Primary Citations — 7 traced to source
- § 11.10 Controls for closed systems.
- § 11.30 Controls for open systems.
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- Discovery (free): /api/v1/nodes/us-fda-cfr-21-part-11-electronic-records.json — 6-field metadata
- Vault (full node): /api/v1/vault/nodes/us-fda-cfr-21-part-11-electronic-records.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
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