J jdm2008 Sep 24, 2014 #1 Sep 24, 2014 #1 Do you IQ microscopes at your facility? Does the FDA expect microscopes that do not take a measurement to be IQed?
Do you IQ microscopes at your facility? Does the FDA expect microscopes that do not take a measurement to be IQed?
Ronen E Problem Solver Staff member Moderator Sep 25, 2014 #2 Sep 25, 2014 #2 jdm2008 said: Do you IQ microscopes at your facility? Does the FDA expect microscopes that do not take a measurement to be IQed? Click to expand... Hi, IQ is part of process validation. The microscope needs an IQ only if it takes part in a process that is being validated. Measurement is a separate topic and comes under MSA (GR&R etc.) and calibration. Cheers, Ronen.
jdm2008 said: Do you IQ microscopes at your facility? Does the FDA expect microscopes that do not take a measurement to be IQed? Click to expand... Hi, IQ is part of process validation. The microscope needs an IQ only if it takes part in a process that is being validated. Measurement is a separate topic and comes under MSA (GR&R etc.) and calibration. Cheers, Ronen.