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Dec 22, 2023 · Medical Devices. Databases. The information on this page is current as of Dec 22, 2023. For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations...
Mar 20, 1997 · 21 CFR §11 Electronic Records; Electronic Signatures - Code of Federal Regulations. Title 21. PART 11. CFR. ›. Title 21. ›. Volume 1. ›. Chapter I. ›. Subchapter A. ›. Part 11 - Electronic Records; Electronic Signatures. PART 11 - ELECTRONIC RECORDS; ELECTRONIC SIGNATURES Authority: 21 U.S.C. 321-393; 42 U.S.C. 262.
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). Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered ...
Title 21. Displaying title 21, up to date as of 4/29/2024. Title 21 was last amended 4/29/2024. view historical versions. 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. Subpart A. Previous. Next. Top. eCFR Content.
81 • 21 CFR Part 11; Electronic Records; Electronic Signatures, Electronic Copies of 82 Electronic Records 83 84 Throughout all of these communications, concerns have been raised that some ...
§ 11.30 Controls for open systems. Persons who use open systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and, as appropriate, the confidentiality of electronic records from the point of their creation to the point of their receipt.
§11.1 Scope. (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.
