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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 8

Process Definition Management: Using ISA-88 and BatchML as a Basis for Process Definitions and Recipe Normalization
Presented at the WBF European Conference, November 10–12, 2008, by
Mike PowerBusiness Advisormike.power@bearingpoint.comBearingPoint, Gordonsville, VA 22942 USA
Paul WlodarczykManaging Directorpaulw@thecontentguy.netThe Content Guy, Fairport, NY 14450 USA

Abstract

Life science organizations have been late to adopt certain best practices that have long been widely used in other areas of batch manufacturing. In the face of increasing competition and changing regulatory reporting requirements, pharmaceutical and biotech companies are now looking to standard forms of process definition as a means to accelerate ...

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