|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.firstname.lastname@example.orgHogeschool Gent, Schoonmeersstraat52, 9000 Gent, Belgium|
|Bert Van VreckemLecturer ITbert.email@example.comHogeschool Gent, Schoonmeersstraat52, 9000 Gent, Belgium|
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 ...