RE: Equipment Validation Contribution from PaulS written on 10/5/2004 at 02:25
Original contribution: Equipment Validation written by Dr. Sirsendu Sukul on 10/4/2004 at 11:04) Firstly what category of system/equipment are we talking about?
bespoke or off the shelf.
If bespoke full retrospective DQ,IQ,OQ,PQ can be done. Use FMEA at equipment component subsystems level on DQ info and then compile IQ,OQ. PQ will be based upon the URS compiled by the user group.
If Off the shelf equipment IQ,OQ can be based upon information in the manuals and again PQ can be based upon the URS.
Hope this helps.
Try using the FDA.com or Computer validation discussion boards as these are frequented by more people.
Regards
PaulS
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