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Is anyone ISO 13485 certified and how does Odoo handle the validation requirement?

This is the single biggest roadblock to getting senior management to agree to try Odoo because we were told that Odoo can't be "validated" as required.

I really don't know what this means but I can't believe we can't make this work.


So is anyone ISO 13485 certified and using Odoo and how do you handle validation?


Thanks!!

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Percevent Ducrest
Best Answer

Hello, We are in the same situation and faced this situation with other accounting/ERP software.

My idea is to do a validation by cases. For example:

- Case 1: find all the user of a specific lot of product A, do the search on Odoo and document the outcome. Are you able to trace the specific lot?

- Case 2: you produce a Product A with a component B. Component B is recalled from the manufacturer. Are you able to trace all product A in Odoo and take action (eg. recall of product A to all end user...)

-Case 3: ... define the specific cases based on what you do and what you need to trace

We did this for a previous ''non-validated'' software and it was well accepted during our ISO13485 audit. The most important point is to do something for the validation

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