COTS Validation: Should we validate Windows after each Update?

K

Klaus61

#1
Hello Community,


IEC 62304 requiers validation of OTS, COTS and SOUPs.

My Question is:

is Windows a COTS, and if yes should we do a validation after each update?:(


thanks in advance
Klaus
 
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yodon

Staff member
Super Moderator
#3
I guess in theory the OS should be considered COTS. However, it would be difficult to manage as such since you can't get access to much of the information.

BUT that shouldn't impact the effect on the state of validation as a result of an OS change. I would say YES, ABSOLUTELY you need to re-assess the need for (re)validation after an OS upgrade. (Note that I didn't say it automatically would trigger (re)validation). Do a risk assessment to help justify any actions. Most likely, for a major OS upgrade, you need only do a limited subset of re-test just to establish a baseline level of confidence that no adverse effects are seen. If, on the other hand, your software is relying heavily on OS-provided services and the risk of failure would cause harm, you may be better off re-running the validation.

Ideally, even those annoying (almost daily) OS patches distributed should be considered for impact on the validated state. Again, if you have a human safety critical application, you may need to take a more robust and rigorous approach (possibly including how those patches are rolled out).
 
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