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(b) This part applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted, under any records requirements set forth in agency regulations.

What Is 21 CFR Part 11? 21 CFR Part 11 states that electronic records and electronic signatures are treated the same as paper records and handwritten signatures. Regulated companies with any documents or records in electronic format must comply with the regulation.

21 CFR Part 11: Subpart C - Electronic Signatures In three distinct section, Subpart C establishes: Requirements for identity verification in electronic signatures. Security controls for electronic signatures. Guidance on the usage of logins and passwords.

21 CFR Part 11 compliance basics include: Secure, well-managed streams of information with access control and retrieval. Properly controlled documents with a high level of integrity and protection. Traceability of record histories and iterations.

(b) This part applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted, under any records requirements set forth in agency regulations.

21 CFR Part 11 is a U.S. federal regulation specifying FDA guidelines for electronic Records and Signatures. The regulation applies to pharmaceutical companies and medical device manufacturers, and it requires the companies to implement controls that ensure the integrity of their documents.

The main 21 CFR Part 11 software features are authentication, audit trail, electronic signatures, and data export. Another feature is authorization, which is optional.

21 CFR Subpart C - Subpart C—Recalls (Including Product Corrections)—Guidance on Policy, Procedures, and Industry Responsibilities. § 7.40 Recall policy. § 7.41 Health hazard evaluation and recall classification.