IQ or OQ...?

Hi All
We are in the process of upgrading an EDMS system and one of the scenarios I would like to test in my script is to make sure that the workflow that is initiated before applying the upgrade can be completed successfully after the upgrade.
The fist part of the script needs to be done before installing the upgrades and the second part after upgrading the system. So plz tell me if I can include this in my IQ script, though it seems to be OQ.



I dont see any reason why not, to make it clear to any auditor or any other person thats going to be on the project, I suggest including this into the Validation Plan stating how this testing will be perfomed in the IQ due to the necessity of pre-upgrade testing.


There’s a good general rule of thumb here, I think. From what I’ve seen, the auditors aren’t all that concerned about how you split out things between the *Q procedures. Document what YOU think is the best approach and execute to that. I’ve never seen any issue raised because the auditor thought something should be in OQ but the firm put it in IQ (for example). Of course, you still have to show completeness in verifying requirements.

Unless there is a specific reason/methodology, by starting your testing on one version and completing the test on the new version may actually invalidate your testing. I suggest you upgrade first, complete the IQ then execute the OQ on the new installation.