Validation Plan for earlier version of application

:slight_smile: 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.


If version 5.5 is no longer in use, I would just take the hit and acknowledge the discrepancy. Unless the controls are not in place to ensure it doesn’t happen in the future or for other applications, I don’t even see the need for a CAPA. Sounds like you should be able to demonstrate that it was a one-time lapse and not a systemic failure.


You can go with the documented acceptance for the missed one…there is no need to go back & prepare the document.

You should involve all team which was involved or the major authorities in this acceptance letter for information & rational if any…with a controlled procedure in place for validation documentation steps…(Assuming you already have even for missed one, If Not incorporate as CAPA).

Happy Reading !