What Is 21 CFR Part 11?
21 CFR Part 11 is the FDA regulation that establishes requirements for electronic records and electronic signatures in FDA-regulated industries. It requires validated software systems, secure user authentication, complete audit trails, and tamper-evident electronic signatures that are legally equivalent to handwritten signatures.
When AI systems generate, modify, or process records used in FDA-regulated activities — drug development, manufacturing, quality control, regulatory submissions — those systems must comply with Part 11. Key requirements include:
- System validation: AI systems must be validated for their intended use with documented evidence
- Audit trails: Every AI interaction must be logged with timestamp, user identity, and action details in a tamper-evident format
- Electronic signatures: AI-generated records requiring signatures must use compliant e-signature workflows with signature meaning, date/time, and irreversible linking
- Access controls: Role-based permissions ensuring only authorized users can execute, approve, or modify AI-generated records
- Data integrity: Cryptographic controls ensuring records cannot be altered without detection
BioCompute Connection
BioCompute's Evidence Engine is purpose-built for 21 CFR Part 11 compliance, providing immutable audit trails, compliant electronic signatures, and cryptographic integrity verification across all AI interactions.