Document Detail


US quality system requirements for software validation.
MedLine Citation:
PMID:  10186973     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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 This article will discuss the contents of a recent FDA draft guidance document that may reduce this variability.
Authors:
M E Donawa
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Publication Detail:
Type:  Journal Article; Review    
Journal Detail:
Title:  Medical device technology     Volume:  9     ISSN:  1048-6690     ISO Abbreviation:  Med Device Technol     Publication Date:  1998 Mar 
Date Detail:
Created Date:  1998-12-04     Completed Date:  1998-12-04     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  9215490     Medline TA:  Med Device Technol     Country:  ENGLAND    
Other Details:
Languages:  eng     Pagination:  17-20     Citation Subset:  T    
Affiliation:
Donawa and Associates Ltd, Rome, Italy. donawa@srd.it
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MeSH Terms
Descriptor/Qualifier:
Equipment Safety
Equipment and Supplies / standards*
Guidelines as Topic
Humans
Quality Control
Software Validation*
United States
United States Food and Drug Administration

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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