How to document Software used as Monitoring and Measuring Devices (7.6)

[rvanelli]

I hope I'm in the correct forum but my question is how to document software when used as a monitoring and measuring device as it pertains to section 7.6 in the ISO standards. I know it should be verified and reverified at selected intervals but what is the best way to document this verification and reverification?

Thanks, Rick

 

[yodon]

1) Validation Plan
2) V&V protocols
3) execute the protocols
4) write the report(s)

As part of the validation plan, you'll define controls to periodically review the need for re-validation (based on code changes, environmental changes, etc.) and at that time, you would just iterate through the loop again.

Being in a validated state requires that the controls are in place to manage the changes (i.e., a well-defined software development life cycle [SDLC]) so it's by no means a "test once and done" situation.