All
We have a lab SW and it is Part 11 compliant. There is a minor update released for this SW and the user wants to upgrade to this minor release. The previous version was validated.
So how do you go about this validation task? Only test the updated/new features in this new version? Do we need to do more than this?
Thanks in advance.
US FDA
Your (re)validation efforts should be risk based (and risk justified). Evaluate (and document) the change in terms of risk (to product and to process) then make an argument (document) for what validation is required. Since you indicate new features, you probably can’t justify doing no validation. A good approach is to test updated features, new features, and features that are ‘touched’ by those features (regression testing). Did I mention you should document all this? 
I agree with Yodan. Yoo need to develop new addendum protocol for new feature test and reference the original protocol in addendum protocol. Then explinn the scope of the addendum protocol.