DocumentCode
772114
Title
Regulatory requirements for computerised systems in pharmaceutical manufacture
Author
Wyn, Son
Author_Institution
FJ Syst. Ltd., Clwyd, UK
Volume
11
Issue
2
fYear
1996
fDate
3/1/1996 12:00:00 AM
Firstpage
88
Lastpage
94
Abstract
The regulation of software systems in pharmaceutical manufacture has commercial implications for a global multi-billion pound market and potential personal significance for all users of pharmaceutical products. The paper discusses the relevant regulations, their application and interpretation. The most important initiative aimed towards increased understanding of the issues involved has been the publication of guidelines for suppliers of software systems for use in pharmaceutical manufacture. These guidelines are described
Keywords
computer integrated manufacturing; legislation; pharmaceutical industry; software engineering; software standards; commercial implications; guidelines; initiative; legislation; pharmaceutical manufacture; pharmaceutical products; regulatory requirements; software regulation; software standards; software suppliers;
fLanguage
English
Journal_Title
Software Engineering Journal
Publisher
iet
ISSN
0268-6961
Type
jour
Filename
487419
Link To Document