I am involved with a computer/piece of analytical equipment ‘move’. The instrument will be benchmarked before and after the move and is having an IQ/OQ carried out in its ‘new home’. The software, however, is already installed on the computer and has been previously IQ/OQ’d. We want to carry out our tests and the phrase IQ/OQ has, of coure, been bandied about. My opinion is this, we are unable to carry out a true IQ as this has already been done but could i though, document this fact and then merely note where the software is installed etc. so i am just documenting that the software IS installed on the C: drive/certain folders ARE available/location of manuals?? Just for completeness
Or would an auditor see it as a pointless exercise and say it should be called something different. THe IQ isnt a particularly labour intensive exercise and is more for documentation in this case. The actual functionality of the software is being tested in a different set of tests.
[quote=trio_uk]I am involved with a computer/piece of analytical equipment ‘move’. The instrument will be benchmarked before and after the move and is having an IQ/OQ carried out in its ‘new home’. The software, however, is already installed on the computer and has been previously IQ/OQ’d. We want to carry out our tests and the phrase IQ/OQ has, of coure, been bandied about. My opinion is this, we are unable to carry out a true IQ as this has already been done but could i though, document this fact and then merely note where the software is installed etc. so i am just documenting that the software IS installed on the C: drive/certain folders ARE available/location of manuals?? Just for completeness
Or would an auditor see it as a pointless exercise and say it should be called something different. THe IQ isnt a particularly labour intensive exercise and is more for documentation in this case. The actual functionality of the software is being tested in a different set of tests.
Any thoughts/comments greatly appreciated.
J.[/quote]
If i understand this correctly then I would try and do some formal IQ to show that the equipment has being installed correctly after the move (this is a standard approach) then I would explain that the software would not be tested again as it already had been. What you can do is sho that the versions are the same (like for like) this should cover the OQ.
I agree with Graham presuming nothing is changed (not putting on a new OS or new patch level, etc.).
I would think a good approach would be to document your validation plan and say pretty much what you said in the post - that nothing has changed and so IQ on the software is not needed. Always good to have documented decisions with justification.
I agree with the above and would add that once installed in the new place that calibration be done and then a short OQ to prove system operates as intended.