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.
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.