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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.
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.
1. Validation 216 215 The Agency intends to exercise enforcement discretion regarding specific part 11 requirements 217 for validation of computerized systems (§ 11.10(a) and corresponding ...
Mar 20, 1997 · Title 21 PART 11. CFR › Title 21 › Volume 1 › Chapter I › Subchapter A › Part 11. Part 11 - Electronic Records; Electronic Signatures.
224 Pt. 11 21 CFR Ch. I (4–1–22 Edition) the electronic media. The presiding of- ficer shall exercise his or her discretion to restrict or discontinue electronic coverage of a public proceeding, or por- tions of a public proceeding, only if he or she determines that the agency’s in- terest in the fair and orderly adminis- trative process ...
28 Signatures in Clinical Investigations Under 21 CFR Part 11 — Questions and Answers (June 29 2017). 8. ... See 21 CFR 11.1. 10. See § 11.1 and 62 FR 13430 (March 20, 1997). 11.
