RE: RE: OQ / IQ / Alarm tests Contribution from Sanjiv Sharma written on 7/11/2006 at 09:17
Original contribution: RE: OQ / IQ / Alarm tests written by sudhir Kulkarni on 6/21/2006 at 17:41) I agree with Sudhir regarding not starting OQ until the IQ is finalized, unless you have an interim signoff within the protocol which allows you to continue pending closure of minor deviations that do not impact on the functionality of the equipment.
I do disagree though, the need to test alarms 3 times, as current regulations require software to be validated(source code review) in the case of bespoke software. Therefore, you have assurance that there is no dead or redundant code & potential bugs. Simple systems tend to display an error message when something goes wrong e.g weigh scale.
As part of the IQ test, you must ensure that you have included an electrical wiring check to make sure the system is integral & meets the design intent.
An alarms list is normally provided by the vendor,and these should all be tested.
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