title: FDA final guidance on software validation.
abstract: The United States Food and Drug Administration (FDA) places considerable importance on the validation of software contained in and used to design, develop, or manufacture medical devices. This article discusses a recently published final FDA guidance document on software validation and the reasons for its importance.
authors.affiliation: Donawa and Associates Ltd, an Aventor Partner, Via Fonte di Fauno 22, 1-00153 Rome, Italy. donawa@srd.it
authors.forename: Maria
authors.initials: M
authors.lastname: Donawa
mesh_terms: D003199:Computer Systems / Q000592:standards*; D017408:Guidelines as Topic; D006801:Humans; D011786:Quality Control; D012308:Risk Management / Q000331:legislation & jurisprudence / Q000592:standards; D012984:Software / Q000331:legislation & jurisprudence*; D012986:Software Validation; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards*