Qualify the HPLC software?

[zheyin]

Our HPLC system is due for annual PM/qualification.
In order to make it fully complaint of GMP,
do I also need to have Empower 3 workstation qualified annually?
It's been installed one year ago with IOQ and AQT on the software.
Please share your experience if you are in a GMP lab. Thanks

[JGK]

I only have GLP experience but you should Have SOPs in place for this type of annual qualification. Minimally you need to check:
Pump flow accuracy (set vs actual)
Oven temp across working range (set vs actual)
Sample compartment temp across working range (set vs actual)
Using a standard method check
Injection reproducibilty (across full injection volume range)
Detector wavelenght accuracy
Dedector linearity

For the software, if the vendor installed and qualified the software they will have done so on the unconfigured software (all user selectable options off). To be fully CFR part 11 compliant, once you configured the user selectable options on the software to fit your facility's requirements you should have run additional OQ test scripts to test these selections were functioning correctly. This would be done prior to allowing the instrument into the working environment.

For the software qualification we would rerun these additional scripts to confirm the same result as the initial testing.

[Bull76]

Hi,

For your Empower 3 software then it would need to be AQT'd again if that is what you have written in your Sop's. It's really up to the customer what then require.

Regards,
Bull76