Could I combine IQ, OQ and PQ for Minitab Software Validation ?


Bill Mac

I am starting the process of validating Minitab for our facility and would like to know if it is possible to combine the IQ, OQ and PQ together. Since the software is already validated by Minitab I only need to verify our internally installed software. I ran the Minitab validation Kit from Minitab and that seemed to pass.
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Re: Statistical Software Validation

Yes, we often perform all 3 together. We also tend to put in provisions in case something is changed that doesn't require the entire IQ/OQ portion, where we can simply redo the PQ portion.

Bill Mac

Re: Statistical Software Validation

Thanks for the reply. Would you be willing to include a sample of how this combined protocol was done and/or laid out? I assume that the provision you mentioned would cover upgrades to the version of the software.
Thanks again and hope I can return the favor.


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Re: Statistical Software Validation

why do you even use the IQ/OQ/PQ process for validating off-the-shelf software that does not control any hardware?

Even the FDA does not use this process/terminology; see the FDA Guidance: "General Principles for Software Validation".

Write a list of your requirements for what the software should do; conduct a risk assessment (can't imagine much risk with a standard off-the-shelf product that is widely used by many users); come up with some uses cases and test them.

I also recommend reading AAMI TIR:36 Validation of Software for Regulated Processes.
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