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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 17

Lean Computer Validation through a Risk-based Approach: A Case Study
Presented at the WBF North American Conference, March 5–8, 2006, by
Peter Werner ChristensenQuality Professionalpwch@nne.dkNNE A/S, Gladsaxevej 363, DK- 2860Soeborg, Denmark

Abstract

In the past, a substantial Supervisory Control And Data Acquisition (SCADA) upgrade would have caused full revalidation, including updates of basically all documentation and verification of a major part of the original functionality. This activity is costly and time-consuming. This chapter describes how to save up to 75% of the expected cost by applying risk assessment to the changes to the system so that risks are identified and eliminated, a feasible level of revalidation ...

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