Which ERP system complies to medical device regulations?

A

alexeyb

#1
My company is working in the medical device field and we are in the process of implementing an ERP solution.

What sort of ERP systems are compliant with the medical device regulations? What ERP system do you use in your company? I've heard that you cannot use the cloud-based ERP systems for medical device manufacturing because of the automatic updates they make, which would make validation of them very hard, is this true?
 
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Ajit Basrur

Staff member
Admin
#2
I am not sure about cloud based ERP but have seen many of our med device and pharmaceutical customers using SAP. Btw, we also have SAP in our organization.
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yodon

Staff member
Super Moderator
#4
Sagai is exactly correct. You can take a perfectly able-to-be-compliant system and use it in a non-compliant way.

The cloud is a new wrinkle that is still being ironed out. You're correct in that automatic updates would generally result in taking a system out of a validated state. You may want to check to see if there are other options besides pure cloud-based operations; e.g., hosting on a dedicated server. It would probably be costlier but may be easier to defend in the long run.

Validation and the level of validation is expected to be done commensurate with risk. If you do a thorough risk analysis (documenting your findings), did the appropriate level of validation, and had controls in place to monitor the higher-risk areas, it would seem that an open-minded inspector would accept the validation / use of such a system. Not a guarantee but it would seemingly put you in a defensible position.

You would certainly want to get a good contract in place with the could provider and ensure both physical and logical security is well implemented. You would also probably want to get the backup / restore procedure documented & validated.

Plenty of things to consider. The paradigm is moving in that direction so it's going to have to be addressed by the regulatory bodies.
 
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