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


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minitab (statistical analysis software), validation (general)
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  Post Number #1  
Old 9th June 2015, 02:55 PM
Bill Mac

 
 
Total Posts: 5
Question Could I combine IQ, OQ and PQ for Minitab Software Validation ?

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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  Post Number #2  
Old 9th June 2015, 05:27 PM
Candi1024

 
 
Total Posts: 92
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.
Thanks to Candi1024 for your informative Post and/or Attachment!
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  Post Number #3  
Old 10th June 2015, 01:08 PM
Bill Mac

 
 
Total Posts: 5
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.
  Post Number #4  
Old 11th June 2015, 08:46 PM
mihzago

 
 
Total Posts: 122
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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