PMID: 9556432Apr 29, 1998Paper

Computer system validation: an overview of official requirements and standards

Pharmaceutica acta Helvetiae
A HoffmannC Kronseder

Abstract

A brief overview of the relevant documents for companies in the pharmaceutical industry, which are to be taken into consideration to fulfil computer system validation requirements, is presented. We concentrate on official requirements and valid standards in the USA, European Community and Switzerland. There are basically three GMP-guidelines. their interpretations by the associations of interests like APV and PDA as well as the GAMP Suppliers Guide. However, the three GMP-guidelines imply the same philosophy about computer system validation. They describe more a what-to-do approach for validation, whereas the GAMP Suppliers Guide describes a how-to-do validation. Nevertheless, they do not contain major discrepancies.

Citations

Apr 22, 2005·Journal of Veterinary Pharmacology and Therapeutics·K N Woodward

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