Hello every one,
We have an application that is currently at ver 5.12. , it is currently in validated state. However in one of the recent audit it was identified that the earlier version of the application ( Ver 5.5) does not have Validation master plan (though it has URS and other validation documents).
Now I have to respond to this observation andI am thinking the flowing options:
1. Create a Validation plan for the earlier version (ver 5.5) and also create a CAPA plan to address this kind of issues in feature. (But the problem is, I don’t know the exact application functions or architecture for the earlier version (ver 5.5).
2. Just create a CAPA plan to address this kind of issues and close the observation without creating Validation plan.
Please let me know your suggestions and especially if you have any new ideas to handle this problem. Your earlier response is appreciated.