RE: RE: OQ / IQ / Alarm tests
Contribution from Dick Bonner written on 4/7/2002 at 16:16
Original contribution: RE: OQ / IQ / Alarm tests written by John Taylor on 4/1/2002 at 12:41)
In addition to john taylor's comments there should be a DQ (design Qualification) first. Alarm are becomming a hot topic with the FDA and require justification of ranges and all records should be treated as GMP documents. Do not have "nice to have" alarms as these also need to be treated as GMP alarms. The alarm systems should be validated and on a Preventative Maintanence programme to ensure they are functioning correctly. the frequency of testing should be justified and documented.
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