|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.firstname.lastname@example.orgWonderware Invensys, 26561 Rancho PkwySouth, Lake Forest, CA 92630 USA|
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 ...