21 CFR Part 11 Electronic Records and Signatures
by Nick Clark | Published April 25, 2026
21 CFR Part 11 establishes FDA requirements for electronic records and electronic signatures across pharmaceutical, medical device, and emerging AI-medical applications. Training-governance substrate provides architectural foundation.
21 CFR Part 11 Frame
21 CFR Part 11 establishes FDA requirements for electronic records and signatures, with substantial impact on pharmaceutical clinical trials, medical device manufacturing records, and emerging AI/ML training operations.
Architecture Implications
AI/ML training operations increasingly face Part 11 record-integrity requirements. Per-example provenance, training-event lineage, and signature attestation all benefit from architectural substrate.
Architectural Mapping
Training-governance per-example provenance maps to Part 11 audit-trail requirements. Credentialed authority signatures map to electronic-signature requirements.
Part 11 Evolution
FDA emerging Part 11 modernization and emerging AI/ML-specific Part 11 guidance push toward structurally-supported architecture.
