ISO 13485 7.5.6 Validation - Off the shelf Software

QuinnM

Involved In Discussions
#1
Hi,

We develop software under medical devices. Our software team is using a well established version control software for among other things capturing code changes. 13485 7.5.6 Validation of processes for production and service provision has "The organization shall document procedures for the validation of the application of computer software used in production and service provision."

I am interpreting this to mean the off the shelf software we use for version control is required to be validated. Is my interpretation correct?

Thanks
Quinn
 
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yodon

Staff member
Super Moderator
#2
Yes... but remember that you can frame your validation efforts around the risk. No need to go too crazy. Most likely, any failures would be either immediately caught in compiles or regression testing. You'll want to consider your implementation of any hierarchical controls (confirm that not everyone is an admin, for example). If there's a back-end server, you'll want to ensure it's set up per the provider's specs (which may include some database engine requirements as well as general things like memory and OS). It'd be a good idea to assess known issues reported by the provider and confirm that you're unaffected (if so - or how you deal if you are).
 

QuinnM

Involved In Discussions
#3
yodon I looked at 13485 7.5.6 and (I liked your language) no need to go crazy, for the validation is framed around risk.

Thanks Quinn
 

mihzago

Trusted Information Resource
#4
A simple assessment of the things yodon mentioned should be sufficient.
You may sometimes come across expectation that testing is required. It is not. Testing is one of the tools in your validation toolbox, but is not necessary or even suitable in all cases.
 
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