I am not sure this is the right forum to place this in but it sounds the most logical…
it was brought to my attention yesterday that the vendor qualified their application to run on Oracle 10.2.0.4 and we are running that application on oracle 10.2.0.5. someone made the decision that we were willing to take the risk and use the software on the unqualified database platform.
We have done a validation on this system, and are in the midst of a new validation project for this application including an upgrade to a certified version of oracle. Our intent was to do limited validation and base it totally on a functional risk assessment of what functionality we use and what functionality is new.
Right now I am not comfortable with this approach seeing as we have been on an unqualified platform since the system was implemented, but I cannot find anything in the regulations etc to clarify what our plan should be.
Any thoughts, help, advice, direction on where to look would be greatly apprecited!
Jen