cGXP compliance for diagnositc software

[mburk]

My lab would like to use Lab Advisor to perform diagnostics and calibration of our Agilent HPLC detectors. We have moved everything over to Empower and so no longer have the diagnostic capabilities that were available through Chemstation. The IT department is balking at the idea of installing diagnostic software because it isn't 21CFR compliant. They are most concerned about how to explain to auditors that we use a non-certified diagnostic software to say that our HPLC systems are validated under cGXP. Has anyone else encountered this? Is there really an issue here?

[mishrrajesh]

You can ask the vendor, they will clarify the situation.

[scottythree]

Potential work around may be by getting the hand held "gameboy" controller installed on your LC's. I know that many of diagnostic test in Chemstation are on the controllers. Perhaps qualify one controller as a mobile plug and play to use for the purposes of calibration verification on each of your systems.