FDA final guidance on software validation.
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.
Donawa
Maria
M
Donawa and Associates Ltd, an Aventor Partner, Via Fonte di Fauno 22, 1-00153 Rome, Italy. donawa@srd.it
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*