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Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures (ERES).
1 paź 2024 · This document provides guidance to persons who, in fulfillment of a requirement in a statute or another part of FDA's regulations to maintain records or submit information to...
5 wrz 2023 · Specifically, 21 CFR Part 11 governs electronic records and signatures in the FDA-regulated landscape and is more specific, while EU GMP Annex 11 guides computerized systems in the EU's GMP-regulated activities focusing on general guidance, effective implementation, and validation.
3 mar 2023 · 21 CFR Part 11 is divided into three sub-parts: The General Provisions section discusses the scope of the regulations, when and how it should be implemented, and defines some of the key terms used in the regulations.
19 lip 2023 · FDA 21 CFR Part 11 specifies the requirements for electronic records and signatures to be considered trustworthy, reliable, and equivalent to paper records and signatures on paper. Here, we will provide a concise overview of the sections of 21 CFR Part 11 and emphasize its key requirements.
8 wrz 2022 · Essentially, Part 11 applies to electronic records and electronic signatures. Electronic records aren’t just limited to documents – they can be records in a database such as electronic case report forms (eCRFs).
4 cze 2024 · Put simply, Part 11 sets out how a life science company operating in the US can establish an FDA-compliant, digital Quality Management System using electronic records and e-signatures in place of paper-based documentation and ‘wet signatures'. Are your e-signatures FDA compliant? Download our 21 CFR Part 11 checklist to find out.
