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View Title 21 on govinfo.gov; View the PDF for 21 CFR Part 11; These links go to the official, published CFR, which is updated annually. As a result, it may not include the most recent changes applied to the CFR. Learn more.
Dec 22, 2023 · 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 (eCFR). Sec. 11.100 General requirements. (a) Each electronic signature shall be unique to one individual and shall not be reused by, or reassigned to, anyone else.
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 ...
Dec 22, 2023 · For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). Sec. 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 ...
Mar 20, 1997 · Title 21 PART 11. CFR › Title 21 › Volume 1 › Chapter I › Subchapter A › Part 11. Part 11 - Electronic Records; Electronic Signatures.
eCFR :: 21 CFR Part 11 Subpart A -- General Provisions. 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.
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 ...
