QMS software validation - Documentation

[snoopy2017]

Hi everyone,

Where in the QMS do software validation plans and reports exist? Should they be part of a DMR? To my knowledge, something like ERP validation is not device specific, so should its validation plans and report be integrated into the general QMS? Thanks. I look forward to your response.

 

[yodon]

There is product software (software in a device or software that is a device) and non-product software (that which is used in the execution of the QMS).

Product software (which is clearly extended down to low-level firmware!) does, indeed, have validation (and verification) plans and reports which are part of the DHF but wouldn't be part of the DMR.

Non-product software (your ERP example), would also have validation plans and reports but these are just kept as quality documents / records and, since not part of the product, would be outside of the DMR or DHF.

Does that help?

 

[uwamahoro]

Hi everyone,
Regarding the above discussion. our company deals with distribution of medicaL devices. I would like to know in which way , computer validation principle of ISO 13485 is applicable to our company..... we are in the process of compiling our quality manual and your input will be appreciated. Thank you

 

[yodon]

If you use software to support the distribution effort (consignee information, etc.) then I expect you would need to validate that software.

I generally recommend taking inventory of ALL software applications used and then determining if any are used in execution of the QMS. If not, validation isn't required. If so, then it probably is. Documenting the decision process is helpful, IMO.

 

[uwamahoro]

Thank you so much for the reply. I will think documenting the decision process will work well us.

 

[olieidel]

Building upon @yodon's answer, also note that the process for validating product vs. non-product software is different: For non-product software it's software validation based on the ISO 13485, for product software it boils down to SOUP (heh) verification / validation as per IEC 62304