Electronic records/signatures Drug Administration

Electronic Records, Electronic Signatures Final Rule, 21 CFR Part 11, Federal Register, Vol. 62, No. 54, US Food and Drug Administration, Rockville, MD (1997). Also available on the World Wide Web http //www.fda.gov/ora/compliance refypartll/default.htm. 

FDA Guidance for Industry, Part 11, Electronic Records Electronic Signatures - Scope and Application (Final version, August 2003), Center for Dmg Evaluation and Research (CDER), US Food and Drug Administration (FDA), Beltsville, MD, USA, 2003. 

Food and Drug Administration. Guidance for Industry, 21 CFR Part 11 Electronic Records Electronic Signatures—Scope and Application, FDA, Rockville, MD, 2003. 

Food and Drug Administration (FDA). Code of Federal Regulations Title 21, Part 11, electronic records and electronic signatures. Federal Register 1997 62 13, 430-66. 

In March 1997, the US Food and Drug Administration (US FDA) issued a regulation on electronic record and signatures 21 CFR Part ll.30 The scope of 21 CFR Part 11 is to... 

FDA (1991), Electronic Signatures and Electronic Records, Code of Federa Regulation Title 21 Part 11, Food and Drug Administration, Rockville, MD. 

CFR Part 11 — Electronic Records Electronic Signatures, U.S. Food and Drug Administration, Department of Health and Human Services, Rockville, MD. 

FDA (2001), Guidance for Industry 21 CFR Part 11, Electronic Records Electronic Signatures Validation (Draft), U. S. Eood and Drug Administration, August. 

United States Food and Drug Administration 21 Code of Federal Regulations, Part 11 Electronic Records Electronic Signatures... 

Until recently, paperless manufacturing operations were held back in the pharmaceutical industry because the U.S. Food and Drug Administration (FDA) did not accept electronic signatures. This obstacle was formally removed when the U.S. GMPs (Good Manufacturing Practices) were enhanced to accept electronic records and signatures under specified conditions by... 

An important issue for regulatory authorities is the reconstruction of conclusions and reported results. Evidence of data integrity can often he based on the chronological sequence of events. The U.S. Food and Drug Administration (FDA) regulation 21 CFR 11, dealing with electronic records and electronic signatures, mentions in 11.10(e) one of the controls that must be used ... 

FDA (US Food and Drug Administration) (2003a), Guidance for Industry Part 11, Electrtmic Records Electronic Signatures — Scope and AppUcatum [freely available at http //www.fda. gov/cder/guidance/5667fhl.pdf]. 

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