FDA Microscope IQ (Installation Qualification) Requirements

J

jdm2008

#1
#1
Do you IQ microscopes at your facility? Does the FDA expect microscopes that do not take a measurement to be IQed?
 
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Ronen E

Ronen E

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#2
#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.
 
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