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1. www.fda.gov › regulatory-information › search-fdaPart 11 Electronic Records Electronic Signatures Scope and ...

   www.fda.gov › regulatory-information › search-fda

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   Under this narrow interpretation, FDA considers part 11 to be applicable to the following records or signatures in electronic format (part 11 records or signatures): Records that are...

2. www.ecfr.gov › chapter-I › subchapter-AeCFR :: 21 CFR Part 11 -- Electronic Records; Electronic ...

   www.ecfr.gov › chapter-I › subchapter-A

   Such procedures and controls shall include the following: ( a) Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records. ( b) The ability to generate accurate and complete copies of records in both human readable and electronic form suitable for inspection ...

3. en.wikipedia.org › wiki › Title_21_CFR_Part_11Title 21 CFR Part 11 - Wikipedia

   en.wikipedia.org › wiki › Title_21_CFR_Part_11

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   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 ...

4. www.accessdata.fda.gov › scripts › cdrhCFR - Code of Federal Regulations Title 21 - Food and Drug ...

   www.accessdata.fda.gov › scripts › cdrh

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   Dec 22, 2023 · DEPARTMENT OF HEALTH AND HUMAN SERVICES. SUBCHAPTER A - GENERAL. PART 11. ELECTRONIC RECORDS; ELECTRONIC SIGNATURES. Subpart A - General Provisions. Sec. 11.1 Scope.

5. ecfr.io › Title-21 › Part-1121 CFR §11 Electronic Records; Electronic Signatures - Code ...

   ecfr.io › Title-21 › Part-11

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   Mar 20, 1997 · Title 21, part 11 of the Electronic Code of Federal Regulations.

6. People also ask

   What does part 11 apply to?

   • Part 11 applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted under any records requirements set forth in Agency regulations.

   Part 11, Electronic Records; Electronic Signatures - Scope and

   www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application

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   What is 21 CFR Part 11?

   • Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records (Title 21 CFR Part 11 Section 11.1 (a)).

   Title 21 CFR Part 11 - Wikipedia

   en.wikipedia.org/wiki/Title_21_CFR_Part_11

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   What are FDA part 11 regulations?

   • BACKGROUND In March of 1997, FDA issued final part 11 regulations that provide criteria for acceptance by FDA, under certain circumstances, of electronic records, electronic signatures, and handwritten signatures executed to electronic records as equivalent to paper records and handwritten signatures executed on paper.

   Part 11, Electronic Records; Electronic Signatures - Scope and

   www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application

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   Does part 11 apply to electronic records?

   • Part 11 also applies to electronic records submitted to the Agency under the Federal Food, Drug, and Cosmetic Act (the Act) and the Public Health Service Act (the PHS Act), even if such records are not specifically identified in Agency regulations (§ 11.1).

   Part 11, Electronic Records; Electronic Signatures - Scope and

   www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application

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