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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)).
In the UK, computer validation is covered in Annex 11 of the EU GMP regulations (EMEA 2011). The FDA introduced 21 CFR Part 11 for rules on the use of electronic records, electronic signatures (FDA 1997). The FDA regulation is harmonized with ISO 8402:1994, [6] which treats "verification" and "validation" as separate and distinct terms.
GAMP itself was founded in 1991 in the United Kingdom to deal with the evolving U.S. Food and Drug Administration expectations for good manufacturing practice (GMP) compliance of manufacturing and related systems. [4]
The manufacturers of pharmaceuticals have to follow several international regulations like FDA 21 CFR Part 11, GMP, Gamp 5, USP<1058>, which require a lot of documentation work. The manufacturers of automatic refractometers support these users providing instrument software fulfills the requirements of 21 CFR Part 11, with user levels ...
Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (ONDCP). [1] It is divided into three chapters: Chapter I — Food and Drug Administration
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Similarly, The Rules Governing Medicinal Products in the European Union, Volume 4, Annex 11: Computerised Systems applies to all forms of computerized systems used as part of a GMP regulated activities and defines Computer System Validation Elements [2]