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.
For what i understood, it should look like a “functionnal tests report”.
We were informed that $BigERP is not ISO 13485:2016 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 ?