software upgrade recomendation for hplc

[mirac_han]

Hi everybody, i'll ask a a question about instrument qualification. We upgrade our hplc software. What test do we do after this upgrade? I read a alot of topic this stiuation. Some topic says you do software iq, oq and hardware PQ test. Can we do all hardware test for our instrument after the upgrade our software? Is it neccesary? Thanks.

[bunnahabhain]

To make it short: it depends on your needs. If you are working in a regulated environment: Check and document everything. If you are working at university: Install, check if it works and be happy if yes.

[unmgvar]

in a regulated environment you need to check that your work is unaffected by the change
so you need to do a change control,
for the software itself this means to see that it is IQ, OQ, PQ
in relation to the hardware attached to it, the best thing to do is to show that basic functions are correct
so you check that the system can be controled correctly by the new upgrade
basic thing to do is simply inject a 2 row injections sequence
this takes care of all major and important control functions
you can do any type of application
you can use the first work you are going to run on the newly upgraded software

if you are not GLP, ISO and so forth
simply go ahead and make a few runs and see that things are alright