21 CFR Part 11 and Pharmaceutical Best Practices
21 CFR Part 11 is the FDA regulation for electronic records and electronic signatures. It establishes the criteria under which electronic records and signatures are considered trustworthy, reliable, and equivalent to paper records and handwritten signatures.
Key Requirements of 21 CFR Part 11
Electronic Records
- Must be accurate, complete, and retrievable
- Must have audit trails to track changes
- Must have controlled access (e.g., usernames, passwords)
Electronic Signatures
- Must be unique to an individual
- Must be linked to records
- Must include name, date, time, and purpose
System Validation
- Companies must validate that their software meets FDA compliance
- Validation ensures data integrity, security, and reliability
Security Controls
- Access controls (only authorized users can modify records)
- Time-stamped audit trails (to track changes and deletions)
- Data backup and recovery
Who Needs to Comply?
Any company in the pharmaceutical, biotech, medical device, or food industry that submits electronic records to the FDA must comply with 21 CFR Part 11.
Read also:
- Paragraph IV (Para IV) Filing | Overview & Strategies
- Difference Between 21 CFR Part 11 and EU GMP Annex 11
- Discussion Topics of the 21 CFR Part 211
Resource Person: Drx. SATISH MANE
