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Software Validation for Measurement Tools used in Process Validation

KatieQA

Starting to get Involved
#1
Working on a Master Validation Plan. Does software used as a measurement tool during process validation require validation? Assume said software will not be used for on-going process monitoring following the process validation.
 
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yodon

Staff member
Super Moderator
#2
Interesting question.

Without knowing more, I would say yes. What are the risks if the output is wrong?

It's probably unlikely that an auditor / inspector would drill down to that level but you still want to have assurance that the outputs are valid, that it properly handles data (in and out of range, if possible), etc.
 

KatieQA

Starting to get Involved
#3
Interesting question.

Without knowing more, I would say yes. What are the risks if the output is wrong?

It's probably unlikely that an auditor / inspector would drill down to that level but you still want to have assurance that the outputs are valid, that it properly handles data (in and out of range, if possible), etc.
Good question / point. And I think you are right. I just wanted to make sure before going down a rabbit hole. I think I'm going to keep the software validation simple (commensurate with the risk) and show agreement with a NIST traceable tool during the course of process validation.
 
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