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THE WBF BOOK SERIES--ISA 88 and ISA 95 in the Life Science Industries by The WBF

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CHAPTER 14

MES Roll-out in a Regulated Environment: Reducing the Costs of Validation Based on Risk Assessment
Presented at the WBF European Conference, November 13–15, 2006, by
Wim De BruynLecturer ITwim.debruyn@hogent.beHogeschool Gent, Schoonmeersstraat52, 9000 Gent, Belgium
Bert Van VreckemLecturer ITbert.vanvreckem@hogent.beHogeschool Gent, Schoonmeersstraat52, 9000 Gent, Belgium

Abstract

Manufacturing Execution Systems (MES) are used more and more in regulated environments (e.g., pharmaceutical, food, chemical production) to control the production processes. When implementing an MES solution in a regulated environment, rigorous and well-documented validation is a mandatory part of the roll-out.

It is important to perform ...

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