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  1. 21 CFR Part 11 -- Electronic Records; Electronic Signatures

    (a) For records required to be maintained but not submitted to the agency, persons may use electronic records in lieu of paper …

  2. Part 11, Electronic Records; Electronic Signatures - Scope and ...

    This guidance is intended to describe the Food and Drug Administration's (FDA's) current thinking regarding the scope and …

  3. eCFR :: 21 CFR Part 11 -- Electronic Records; Electronic Signatures

    The Electronic Code of Federal Regulations (eCFR) is a continuously updated online version of the CFR. It is not an official legal …

  4. CFR - Code of Federal Regulations Title 21 - Food and Drug Administration

    Dec 24, 2024 · For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

  5. Title 21 CFR Part 11 - Wikipedia

    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 …

  6. 21 CFR Part 11 - ELECTRONIC RECORDS; ELECTRONIC SIGNATURES

    Mar 20, 1997 · LII Electronic Code of Federal Regulations (e-CFR) Title 21—Food and Drugs CHAPTER I—FOOD AND DRUG …

  7. FDA 21 CFR Part 11: Complete Compliance Guide (2026)

    Feb 21, 2026 · FDA 21 CFR Part 11 is the U.S. Food and Drug Administration regulation that defines the criteria for trustworthy …

  8. This part applies to records in electronic form that are created, modiEed, maintained, archived, retrieved, or transmitted, under any …

  9. 21 CFR Part 11 | Electronic Records; Electronic Signatures | eCFR.io

    Jul 9, 2026 · Browse 21 CFR Part 11, Electronic Records; Electronic Signatures. current through 2026-07-09.

  10. (d) Electronic records that meet the requirements of this part may be used in lieu of paper records, in accordance with §11.2, unless …