title: Computer system validation: an overview of official requirements and standards.
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.
authors.affiliation: Institute for Hygiene and Applied Physiology, Applied Vision Research, ETH Zentrum, Zurich, Switzerland.
authors.forename: A
authors.initials: A
authors.lastname: Hoffmann
authors.forename: J
authors.initials: J
authors.lastname: Kähny-Simonius
authors.forename: M
authors.initials: M
authors.lastname: Plattner
authors.forename: V
authors.initials: V
authors.lastname: Schmidli-Vckovski
authors.forename: C
authors.initials: C
authors.lastname: Kronseder
mesh_terms: D003199:Computer Systems / Q000331:legislation & jurisprudence / Q000592:standards*; D004345:Drug Industry / Q000331:legislation & jurisprudence / Q000592:standards*; D004867:Equipment Design; D005060:Europe; D017408:Guidelines as Topic; D008491:Medical Informatics Applications; D012985:Software Design; D012986:Software Validation; D013557:Switzerland; D014481:United States