O'Reilly logo

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

Stay ahead with the world's most comprehensive technology and business learning platform.

With Safari, you learn the way you learn best. Get unlimited access to videos, live online training, learning paths, books, tutorials, and more.

Start Free Trial

No credit card required

CHAPTER 4

Impact of Batch Software Upgrades on Validated Batch Applications
Presented at the WBF North American Conference, April 13–16, 2003, by
Shri MariyalaSenior Batch Support Engineersrinivas.mariyala@wonderware.comWonderware Invensys, 26561 Rancho PkwySouth, Lake Forest, CA 92630 USA

Abstract

Batch software upgrades for validated batch applications raise many issues. This chapter describes guidelines for how much revalidation evidence is needed to meet regulatory requirements for validated batch applications, if changes are made to software that is utilized in developing these automated applications. In addition, this chapter talks about the benefits and liabilities expected after making upgrades to batch software.

Often, it ...

With Safari, you learn the way you learn best. Get unlimited access to videos, live online training, learning paths, books, interactive tutorials, and more.

Start Free Trial

No credit card required