Impact of Batch Software Upgrades on Validated Batch Applications

Overview:

Batch software upgrades on validated batch applications raises many issues. This paper talks about guidelines on how much revalidation evidence is needed to meet regulatory requirements for validated batch applications, if changes made to software that is utilized in developing these automated applications. In addition, the benefits and liabilities expected after making upgrades to batch software. Often, it is difficult to estimate the level of testing effort needed to perform on a production system after implementing software upgrades. The outcome of this testing/documentation should provide sufficient data to demonstrate that software upgrades have no negative impact on equipment/product/process performance and the system has been restored to its validated status. This is the absolute requirement for Pharmaceutical Companies and should meet the guidelines required by FDA and internal company standards.

There's More to This Story
Get more. You can read the rest of this story and other exclusive content as a Control Global community member. It's FREE, and it’s easy. We just need your name and email address. Then you can read everything you want on our site and even comment on it.

Author: Shri Mariyala, WBF

Find more white papers on Batch Management

View all white papers»