21 CFR Part 11
FDA Electronic Records and Electronic Signatures
FDA regulations establishing criteria for electronic records and signatures in pharmaceutical and medical device industries.
What is 21 CFR Part 11?
21 CFR Part 11 establishes the FDA's regulations on electronic records and electronic signatures. It defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records and handwritten signatures.
Part 11 applies to records required by FDA predicate rules (GMP, GLP, GCP, etc.) that are maintained in electronic format. Compliance requires implementing controls for system validation, audit trails, access controls, authority checks, and electronic signatures that meet specific technical and procedural requirements.
Who Needs 21 CFR Part 11?
- Pharmaceutical manufacturers
- Medical device companies
- Biotechnology firms
- Contract research organizations
- Clinical trial sponsors
Key Requirements
Core compliance areas for 21 CFR Part 11
System Validation
Validate systems to ensure accuracy, reliability, and consistent intended performance.
Audit Trails
Generate secure, computer-generated, time-stamped audit trails.
Access Controls
Limit system access to authorized individuals.
Electronic Signatures
Implement electronic signatures meeting identity, authority, and non-repudiation requirements.
Record Protection
Protect records from unauthorized alteration or deletion.
Benefits of 21 CFR Part 11 Compliance
- FDA compliance for electronic systems
- Paperless operations
- Data integrity assurance
- Inspection readiness
- Operational efficiency
- Foundation for digital transformation
Official Resources
Related Frameworks
GxP
FDA and international regulations ensuring quality and safety in pharmaceutical, medical device, and clinical research.
ISO 27001
The international standard for information security management systems (ISMS).
SOC 2
The gold standard for demonstrating security practices to enterprise customers and partners.