Computer system validation approach for Minitab Statistical software

C. Tejeda · Oct 13, 2022

I am no software validation expert and this has been a good opportunity to Lear something new. Tank you all for your answers.

For the record, if anyone is looking forward to validate this software in the future, I used the Minitab's validation kit to support our internal software validation requirements.

Minitab's kit is very straightforward in providing what should be expected on each test case and it also includes a great script that automates the process of executing the commands. We verified all functions and left out the abbreviated approach I mentioned in my original post since it did not save that much time or effort doing so.

Where we did save some time was just verifying one of the decimal input methods. Minitab can recognize comma and dot as decimal separators and provides a full test scripta to verify that. In the country we are operating dots are used so we left out the comma test cases.

rayhope · Oct 19, 2022

C. Tejeda said:
I have been tasked with the process of validating Minitab for our facility. The company that I work for is a medical device manufacturer (Class I and II products) that needs to meet USA FDA Quality system requirements and ISO 13485.

As per our risk assessment, our main risk with using minitab is that it could yield wrong results (the software would be used to assist on the analysis fo process/design validation reports, CAPA investigations, and Complaint trends). We do aknowledge that a) Minitab has widespread adoption in the industry and b) it is a off-the-shelf (GAMP Category 3) software that will need black-box testing in order to check functionality.

My question is: Is it acceptable, for software validation test scripts, to test a reduced number of functions (lets say a sample) of all the functions minitab has available?

The acceptance criteria four our validation protocol would be something like test 10 functions, if they pass our test script, then the whole system is validated.

I am not the expert in CSV but what I believe is Minitab is well establish widely use software where you do statistical analysis. Basic assumption is algorithm and formulae already available and we can not change it. So output(Results ) from Minitab will be uniform. Options available for control of file (Password protection) once data analysis done and its reproducible results getting from Minitab versions. SO its good idea to validated only intended purpose functions rather than whole functions. if you adding any new calculations or algorithm into Minitab Software as per your company requirement then you need validation of Algorithm/calculations.

Computer system validation approach for Minitab Statistical software

C. Tejeda

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rayhope

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