EU GMP Annex XI - What is an "appropriate QMS"?

Wolf.K

Quite Involved in Discussions
#1
Hi,

I wonder if someone can give me advice about EU GMP Annex XI:

4.5 The regulated user should take all reasonable steps, to ensure that the system has been developed in accordance with an appropriate quality management system. The supplier should be assessed appropriately.

We get an ERP (Enterprise Resource Planning) system, and we need to audit the supplier. It is a system based on Microsoft Dynamics NAV and is cloud-based in a private cloud in MS Azure. Now I wonder: what IS an appropriate quality management system, and how should I assess our supplier appropriately? ISO 12207, GAMP 5, ISO 9001, or else? Or just see that they have a "normal" QMS, that is: controlled SOPs and people following the instructions?

Truly yours,
W.
 
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yodon

Staff member
Super Moderator
#2
We get an ERP (Enterprise Resource Planning) system, and we need to audit the supplier.
The other question aside, why do you feel you need to audit the supplier? (Not necessarily a bad thing, just curious).

Also, are they writing the application for you or is this commercial software (that maybe they'll customize?)?

what IS an appropriate quality management system, and how should I assess our supplier appropriately? ISO 12207, GAMP 5, ISO 9001, or else?
Only ISO 9001 in your list is a quality management system. 12207 is a software lifecycle document (as is IEC 62304) and GAMP 5 is focused on validation but touches on lifecycle matters (in context of validation).

Or just see that they have a "normal" QMS, that is: controlled SOPs and people following the instructions?
Here's where I'll probably get flamed but is it important to you that they have a quality policy? Is it important that they understand the context of their organization? Those things are all good and demonstrate organizational maturity but what would be important to me is that they do have a well-defined software life cycle, have controls in place to properly manage changes, employ state-of-the-art software configuration management, etc.

Someone could have a stellar QMS but not fully understand software engineering (not their "core competency").

Circling back to the audit question: if you audit them, is it more important to examine, say, purchasing controls or dig into the software development practices?

Do keep in mind the last sentence of that excerpt from Annex XI 4.5: The supplier should be assessed appropriately. I take that as "do what makes most sense."
 

Wolf.K

Quite Involved in Discussions
#3
A lot of good points!


Personally I don't like it if a law or standard just says "appropriate" without defining it. So, as you point out, our primary goal will be to see if they are able to develop good software. The ERP fulfills requirements for tracability, complaint management, storage management, production controls, and else, it is very important that it complies with the regulations. As the company has a QMS but no certificates (neither 9001 or else), we have to audit them. (As the software is based on MS Azure and the company is hosting a private cloud at the Microsoft Data Center, we have to audit MS too, but that is impossible because they do not let anyone on their premises. Another obstacle I will have to find a solution...).



So, I will focus on their (1) CAPA system (2) complaint system (3) change control (4) software development, e.g. bug tracking and version control.
 
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