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