US quality system requirements for software validation.
United States (US) Food and Drug Administration (FDA) investigators have, for many years, consistently evaluated compliance with US process validation requirements. Until now there has been significant variability in the manner in which they have examined compliance with US requirements for the validation of software used in the production process or as part of the quality system. This article will discuss the contents of a recent FDA draft guidance document that may reduce this variability.
Donawa
M E
ME
Donawa and Associates Ltd, Rome, Italy. donawa@srd.it
D004869:Equipment Safety; D004864:Equipment and Supplies / Q000592:standards*; D017408:Guidelines as Topic; D006801:Humans; D011786:Quality Control; D012986:Software Validation; D014481:United States; D014486:United States Food and Drug Administration