21 CFR Part 11 – Electronic Records & Electronic Signatures

Food and Drug Administration (FDA) 21 CFR Part 11 regulates electronic records and electronic signatures for FDA-regulated industries, including pharmaceuticals and medical devices. It ensures electronic records are authentic, secure, and legally equivalent to paper records.

Key Components of 21 CFR Part 11

• Electronic Records – Digital data created, stored, or transmitted by computer systems.
• Closed Systems – Access controlled by authorized users.
• Open Systems – Broader access requiring added controls like encryption.
• Electronic Signatures – Unique, verified digital signatures legally equal to handwritten signatures.

Compliance Requirements

21 CFR Part 11 requires secure access controls, audit trails, system validation, password management, and identity verification. Electronic records and electronic signatures can replace paper records if 21 CFR Part 11 requirements are fully met.

Proper implementation of 21 CFR Part 11 ensures data integrity, regulatory compliance, and secure electronic record management.