Software validation (4.1.6 ISO 13485:2016)

Jeffbbt

Starting to get Involved
#21
The requirement is for systems that "have an effect on product quality". Therefore, if a paper system is used as the QMS, and it is controlled appropriately for the system, the ERP would not need to be validated as it would not affect product quality.

If I were auditing this situation, I would make sure the employees were using the paper system, not the ERP. If the ERP was being used to pull production documents, there would be findings as this would affect product quality and the system was not validated. If the employees knew to pull paper copies only, and used the ERP for things such as backups or convenience, then this would be acceptable. Could someone look at the ERP and see a document there that was not in the paper copy?

Finally - if the ERP is only used for financial information, this would not affect product quality and therefore have a very low risk rating, and could be justified to not require validation. But if it is information on inventory (perhaps a supplier? A supplier qualification?) then this could require validation.

So as Richard said. It isn't very straightforward, but sounds like you could get away without validation. I think this is the reason many places still hold on to paper.
 
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