Hi everyone, please forgive my english since it’s not my first language.

I’m currently on an internship for a small medical devices production business and we plan to use $BigERP in commercial, accounting, production and traceability tasks.

The ISO 13485:2016 , at section 4.6.1 enforces software validation to bring the evidence that the software works as expected.

For what i understood, it should look like a “functionnal tests report”.

We were informed that $BigERP is not ISO 13485: certified, and has a crapload of modules we plan to use. If we start the validation process internally, we’re not 100% certain to finish it when the next audit comitee comes…

How could my business do to validate this solution with minimal workload ?

Source link https://www.reddit.com/r//comments/904kic/how_to_validate_a_big_erp_solution_according_to/


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