What 21 CFR Part 11 - Electronic Records; Electronic Signatures requires
This regulation establishes the US Food and Drug Administration (FDA) criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records and handwritten signatures.
Pillar: Medical & Healthcare · Authority: US 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: 5c83d3f69febec1a82209f0e1888f1e761ca4ec8d3ba7c7793ef563f61142153
Primary Citations — 7 traced to source
- 21 CFR Part 11, § 11.10: Controls for closed systems.
- 21 CFR Part 11, § 11.30: Controls for open systems.
+ 5 more citations (full bibliography, deterministic workflow, actionable schema and crosswalks) included in the vault unlock — $0.01 via Skyfire / L402 / Direct Base USDC.
Access
- Discovery (free): /api/v1/nodes/us-21-cfr-part-11-electronic-records-electronic-signatures.json — 6-field metadata
- Vault (full node): /api/v1/vault/nodes/us-21-cfr-part-11-electronic-records-electronic-signatures.json — full 13-key payload, $0.01 USDC (L402/Skyfire/Direct Base)
- Canonical URL: https://bidda.com/intelligence/us-21-cfr-part-11-electronic-records-electronic-signatures
- Back to registry: Browse all 10,090 compliance nodes