21 CFR Part 11

21 CFR Part 11 is a federal regulation by the FDA that defines the criteria for using electronic records and electronic signatures in place of paper documents. It ensures that digital data is as trustworthy and reliable as traditional handwritten entries.

Key Compliance Requirements of Part 11

For manufacturers using automated systems (e.g., MES, LIMS), the following technical controls are mandatory:

• Computer-Generated Audit Trails: A secure, time-stamped record of all operator actions. Modifications must not obscure previous information.
• System Validation: Documented proof that the system consistently performs its intended functions correctly.
• Record Protection: Safeguards to prevent the deletion or alteration of data throughout the retention period.
• Electronic Signature Standards: Signatures must be unique to an individual, verified before assignment, and include the printed name, timestamp, and meaning (intent).

Why Compliance Matters

Non-compliance with 21 CFR Part 11 can lead to severe consequences, including FDA warning letters (Form 483), product recalls, or loss of manufacturing licenses. Implementing a compliant system reduces the risk of human error and ensures Data Integrity (ALCOA+).

Common Pitfalls in FDA Audits

• Shared Passwords: Using generic logins prevents individual accountability.
• Incomplete Exports: Failing to provide human-readable copies of the full audit trail during an inspection.
• Lack of "Reason for Change": Changing critical data without documenting why the override was necessary.