Which regulation provides the rules for electronic records and electronic signatures?

• A. CFR Title 21 Part 11
• B. HIPAA Privacy Rule
• C. HITECH
• D. FDA 21 CFR Part 11

Answer: (A)

Electronic records and electronic signatures are governed by a specific FDA regulation that sets the criteria for trustworthiness, integrity, and accountability of digital records. This regulation is CFR Title 21 Part 11. It requires that electronic systems used to create or manage records be validated, provide audit trails, enforce access controls, and support electronic signatures that are uniquely tied to individuals. In short, it defines how electronic records must be created, maintained, and authenticated to be acceptable for FDA-regulated activities.

HIPAA Privacy Rule (privacy protections for health information) and HITECH (strengthening HIPAA security and promoting meaningful use) address broader privacy and security aspects but do not provide the detailed rules for electronic records and electronic signatures themselves. The FDA’s Part 11 regulation is the specific rule set that governs these electronic aspects, and it is commonly known as 21 CFR Part 11; the form of citation in the option you chose emphasizes the CFR Title 21 Part 11 framing.