Medical Device SPC Software Validation

[Rahulkanety]

We implemented SPC software in our company(medical device) recently, we use SPC software for collecting,retaining data, report making and analysis. One of our customers requested for software validation. How can we validate a software? Do we have any specific requirements to comply as we are medical device company and working towards ISO 13485 certification?

 

[Sam Lazzara]

Re: SPC software Validation

If it is off-the-shelf software, I would start by contacting the supplier to find out if they have validation packages they can provide so you can validate your installation of the software. Minitab, for example, offers such support for validation. They provide data sets and show you what results to look for. Just follow their instructions, keep records, and write a report.

If it is custom (in-house) designed software there is much more involved.

You may find AAMI TIR36 useful - it is a guidance document called "Validation of software for regulated processes".

 

[sagai]

Re: SPC Software Validation

Welcome!
the application of GAMP 4/5 is the answer for u.
br
Sz.

 

[Rahulkanety]

Re: SPC software Validation

Thanks for the info. I contacted my supplier of software, he is providing scripts for Installation verification and Operational verification. But for performance qualification he is suggesting a third party consulting which seems to be a lot of investment. Does every company requires performance qualification?

 

[klraj]

Re: SPC software Validation

I suggest the following for software validation.
a) have the results of the data analysis done manually
b) have the results of the data analysis generated by the tool
Compare the above with various permutation and combination of the data analysis and prove the software works as per its expectation.

 

[Steve Prevette]

Re: SPC Software Validation

Another option is to get a statistics college textbook that covers SPC and has examples with solutions (especially if you could get the teacher's manual). Then plug the problems into the software and see if it matches with the textbook's solution.

 

[bobdoering]

We implemented SPC software in our company(medical device) recently, we use SPC software for collecting,retaining data, report making and analysis. One of our customers requested for software validation. How can we validate a software? Do we have any specific requirements to comply as we are medical device company and working towards ISO 13485 certification?

What processes are you using the software to track?