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Regulatory requirements for computerised systems in pharmaceutical manufacture

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1 Author(s)
S. Wyn ; FJ Syst. Ltd., Clwyd, UK

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.

Published in:

Software Engineering Journal  (Volume:11 ,  Issue: 2 )