What is the clause in ISO 13485 for SAP Software Validation?



Hi everyone,

Where would a software validation document (plan and report) reside in the Quality management system? Specifically, this is validation for an ERP system.

Thank you.


Hi snoopy2017,

I am not sure how you structure your company QMS. For me, I would put in under Process Validation section (link to clause 7.5.6 - ISO 13485 2016 version).


Quite Involved in Discussions
Actually I am currently dealing with the same requirement.

ISO 13485:2016 Clause 4.1.6 applies to this.

Snoopy2017: Good luck with your validation. When I hear the word "SAP" I cringe.


Super Moderator
Maybe I'm just mincing words but to me, a plan and report doesn't go "in" the QMS. The QMS may say that you do validation of software but not contain specifics.

My approach is generally to say that we have a (non-product) software validation program. I have a Master Validation Plan (quite similar in some respects to a product V&V Plan - especially in terms of management) which also establishes a risk-based means to scope validations, an inventory of systems with risk ranking and overall approach to validation, then individual documents (requirements, protocols, reports, etc.) for each application that requires validation. All this is certainly "under" but not contained in the QMS proper.
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