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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 7

Implementing ISA-88 across Life Science Development Operations
Presented at the WBF North American Conference, March 24–26, 2008, by
Louis Ciabattoni, CPIMSr. Product Manager, Life Scienceslciabattoni@conformia.comConformia Software, 150 Mathilda Place,Suite 202, Sunnyvale, CA 94086 USA

Abstract

Implementing ISA-88 may be perceived as a challenge in most industries. The benefits of the ISA-88 standard test this notion—reducing the time to reach full production levels for new products, making recipe development straightforward, and reducing life-cycle engineering efforts, as well as enabling vendors to supply appropriate tools for implementing batch control. Even with new Food and Drug Administration (FDA) recommendations ...

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