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1. www.ecfr.gov › current › title-2121 CFR Part 11 -- Electronic Records; Electronic Signatures

   www.ecfr.gov › current › title-21

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   This part sets forth the criteria for electronic records and signatures that are trustworthy, reliable, and equivalent to paper records and signatures under FDA regulations. It applies to records created, modified, maintained, archived, retrieved, or transmitted under any records requirements set forth in agency regulations.

   • Subpart C

     View the PDF for 21 CFR Part 11 Subpart C; These links go to...

   • Subpart B

     View the PDF for 21 CFR Part 11 Subpart B; These links go to...

   • eCFR Drafting Site

     Chętnie wyświetlilibyśmy opis, ale witryna, którą oglądasz,...

   • 21 CFR Part 10

     21 CFR Part 10 Agency Food and Drug Administration,...

2. www.fda.gov › regulatory-information › search-fda-guidance-documentsPart 11, Electronic Records; Electronic Signatures - Scope and...

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

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   1 paź 2024 · Learn how FDA interprets and applies part 11 of Title 21 of the Code of Federal Regulations, which covers electronic records and signatures in FDA-regulated products. Find out about the scope, requirements, and enforcement discretion of part 11.

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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   Learn about the FDA regulations on electronic records and electronic signatures (ERES) for regulated industries. Find out the scope, coverage, history, and benefits of Part 11, as well as the related guidance and challenges.

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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   30 sie 2024 · Part 11 of the Code of Federal Regulations (CFR) establishes the requirements for electronic records and signatures in the food and drug administration. It covers the scope, implementation, definitions, controls, and components of electronic records and signatures.

5. 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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   30 sie 2024 · This web page shows the text of CFR Title 21 Part 11, which regulates the use of electronic records and signatures in the food and drug industry. It includes the general requirements, components, controls, and certification of electronic signatures.

6. www.fda.gov › media › 75414Guidance for Industry - U.S. Food and Drug Administration

   www.fda.gov › media › 75414

   This document explains FDA's current thinking on the scope and application of part 11 of Title 21 of the Code of Federal Regulations, which covers electronic records and signatures. It also discusses FDA's enforcement discretion and re-examination of part 11 requirements for all FDA regulated products.

7. ecfr.io › Title-21 › Part-1121 CFR 11 - eCFR - Electronic Code of Federal Regulations e-CFR

   ecfr.io › Title-21 › Part-11

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   20 mar 1997 · Part 11 of the Code of Federal Regulations (CFR) establishes the requirements for electronic records and signatures in the food and drug industry. It covers topics such as scope, implementation, definitions, controls, and signature manifestations.