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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.

India passed Information Technology Act 2000 (The Act) which came into force on 17-10-2000. The Act applies to the whole of India and even to persons who commit offence outside India. The Act validates digital signature? and provides for enabling a person to use it just like the traditional signature.

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 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.

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.

The FDA 21 CFR Part 11 requirements apply to companies operating in FDA-regulated industries using electronic records and electronic signatures (eSignatures).

Who does 21 CFR Part 11 apply to? 21 CFR Part 11 applies to clinical trial sponsors, including pharmaceutical and medical device companies, who are conducting FDA-regulated research. It also applies to Clinical Research Organizations (CROs) and research sites.