General

21 CFR Part 11(Part 11)

FDA regulations governing electronic records and electronic signatures to ensure their trustworthiness and reliability.

Usage Examples

The system was validated for Part 11 compliance.
Audit trail functionality meets Part 11 requirements.
Electronic signatures require unique user IDs and passwords per Part 11.

What is Part 11?

21 CFR Part 11 establishes FDA's regulations for electronic records and electronic signatures. The rule ensures that electronic records are trustworthy, reliable, and equivalent to paper records with handwritten signatures.

Part 11 requirements include validation of computerized systems, audit trails that cannot be altered, secure access controls, authority checks, device checks for electronic signatures, and documentation controls. The regulations apply to records required by FDA regulations and signatures required by FDA regulations.

FDA has issued guidance clarifying a risk-based approach to Part 11 compliance, focusing on records that are significant to product quality and safety decisions.

Regulatory Context

This term appears most often in general workflows where submission quality, regulatory evidence, and audit readiness depend on consistent language. It is commonly referenced alongside 21 CFR 11.

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When This Matters

The system was validated for Part 11 compliance.
Audit trail functionality meets Part 11 requirements.
Electronic signatures require unique user IDs and passwords per Part 11.

Common Mistakes

Relying on generic terminology without mapping to the active jurisdiction context.
Skipping cross-links between terms, tools, and active regulatory references.
Failing to maintain a single source of truth for regulatory definitions internally.

Related Regulations

21 CFR 11

Frequently Asked Questions

Systems that create, modify, maintain, archive, retrieve, or transmit electronic records required by FDA regulations, and systems where electronic signatures are the legal equivalent of handwritten signatures.

Key requirements include system validation, audit trails, access controls, authority checks, personnel training, documentation, and for electronic signatures: unique identification, controls to ensure signatures cannot be reused.

Yes, FDA issued guidance in 2003 taking a risk-based approach, focusing on records important to product quality and public health rather than requiring full compliance for all electronic systems.