Which regulation governs electronic records and signatures for the pharmaceutical industry?

• A. 21 CFR Part 820
• B. 21 CFR Part 101
• C. 21 CFR Part 11
• D. 21 CFR Part 201

Answer: (C)

Electronic records and electronic signatures in FDA-regulated contexts are governed by Title 21 CFR Part 11. This regulation sets the criteria for when electronic records are trustworthy and legally equivalent to paper records, and it lays out requirements for validating the systems that create, modify, maintain, archive, and retrieve those records. It also requires robust security and access controls, audit trails that record who did what and when, procedures for protecting the integrity and retention of records, and the use of unique electronic signatures that are linked to their specific records to provide non-repudiation. In the pharmaceutical setting, Part 11 helps ensure data integrity and traceability across activities like manufacturing, quality control, and regulatory submissions.

Other regulations mentioned address different areas: one covers quality systems for medical devices, another governs labeling and nutrition information, and another also relates to labeling regulations. None of these specifically establish the rules for electronic records and signatures in the FDA-regulated pharmaceutical space.