DocumentCode
278503
Title
Assessment of quality critical software in the pharmaceutical industry
Author
Margetts, A.J.
Author_Institution
Comput. Validation Manager, ICI Pharm., Macclesfield, UK
fYear
1991
fDate
33409
Firstpage
42370
Lastpage
42373
Abstract
Concerns the operation of manufacturing computer systems in the Pharmaceutical Industry in a regulated environment called Good Manufacturing Practice (GMP). The main point that the author makes is that the Pharmaceutical Industry has to prove to the regulatory authorities that it is in control of its computer systems. He discusses regulatory requirements, a method of complying with the requirements which involves identifying threats and providing controls to mitigate these threats. The study identifies potential safety or quality problems in a plant computer system
Keywords
manufacturing computer control; medical computing; quality control; software reliability; GMP; Good Manufacturing Practice; Pharmaceutical Industry; manufacturing computer systems; plant computer system; regulatory requirements;
fLanguage
English
Publisher
iet
Conference_Titel
Managing Critical Software Projects, IEE Colloquium on
Conference_Location
London
Type
conf
Filename
181826
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