What FDA 21 CFR Part 11 (Records) requires
FDA 21 CFR Part 11 establishes the U.S. requirements for electronic records and electronic signatures. It defines the criteria under which the FDA considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records.
Pillar: Medical & Healthcare · Authority: US Food and Drug Administration (FDA) · Version: 1.1.0 · Last updated:
Primary source: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11
SHA-256 integrity: b194422f3d57e39bb92d4fbec922228d9e43208ff4f7fb881e0aaa1040e15564
Primary Citations — 6 traced to source
- 21 CFR § 11.10(a) - Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records.
- 21 CFR § 11.10(b) - The ability to generate accurate and complete copies of records in both human readable and electronic form suitable for inspection, review, and copying by the agency.
+ 4 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/fda-21-cfr-part-11-records.json — 6-field metadata
- Vault (full node): /api/v1/vault/nodes/fda-21-cfr-part-11-records.json — full 13-key payload, $0.01 USDC (L402/Skyfire/Direct Base)
- Canonical URL: https://bidda.com/intelligence/fda-21-cfr-part-11-records
- Back to registry: Browse all 10,090 compliance nodes