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Mar 22, 2024 · CFR - Code of Federal Regulations Title 21. The information on this page is current as of Mar 22, 2024. For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal...
This guidance is intended to describe the Food and Drug Administration's (FDA's) current thinking regarding the scope and application of part 11 of Title 21 of the Code of Federal...
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).
Mar 20, 1997 · Title 21, part 11 of the Electronic Code of Federal Regulations.
regulations (21 CFR Part 211), the Quality System regulation (21 CFR Part 820), and the Good Laboratory Practice for Nonclinical Laboratory Studies regulations (21 CFR Part 58)....
Mar 22, 2024 · Sec. 11.2 Implementation. (a) For records required to be maintained but not submitted to the agency, persons may use electronic records in lieu of paper records or electronic signatures in lieu...
(a) The regulations in this part set forth the criteria under which the agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.
Feb 16, 2024 · 21 CFR Part 11 outlines requirements for using electronic records and signatures in lieu of traditional paper-based methods. It establishes guidelines for managing, retaining, and authenticating electronic records to ensure their accuracy, reliability, and confidentiality. Compliance with 21 CFR Part 11 is crucial for companies involved in producing, testing, and distributing FDA-regulated products.
Jun 1, 2023 · What is 21 CFR Part 11? 21 CFR Part 11 is a regulatory framework designed by the FDA to guide drug makers on how to create, manage, and maintain electronic records and electronic signatures. It also says in what conditions drug makers become eligible for compliance with this regulation.
Mar 20, 1997 · Electronic Code of Federal Regulations (e-CFR) Title 21—Food and Drugs; CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES; SUBCHAPTER A—GENERAL; PART 11—ELECTRONIC RECORDS; ELECTRONIC SIGNATURES
