HPLC Firmware upgrade

[michaelcarolus]

Hi All

I need some help on re-qualification of an HPLC which is controlled by Empower.
We are in the process of upgrading our firmware on our Alliance systems e.g.
2695 - version 2.03 to version 2.04
2487 - version 1.01 to version 1.02

Should we reform a complete OQ and PQ on these systems as the firmware has been upgraded. Would a PQ before the firmware upgrade and a PQ after the firmware upgrade be sufficient to satisfy an auditor? We want to compare the PQ before and after the upgrade to show that nothing has changed in the system.

Any advice / suggestions would be greatly appreciated.
Thanks
Mike

[tom jupille]

I'm not sure what else you could do (a full IQ/OQ/PQ seems to be overkill for a minor "dot" revision).

If you want to cover yourself, write an SOP to that effect, maybe getting a memo from your local Waters rep confirming that minor revisions should be handled that way.

[michaelcarolus]

Thanks Tom

We have done a risk assessment and this will guide us in deciding the extent of the re-validation. At least we have a document that will show our reasons for re-validation. We will also contact our local Waters distributor to confirm our rationale.

Regards
Mike