FDA's authority sits with the regulated company using the tool, not the vendor supplying it. A model update happening on the vendor's side does not shift that accountability. It just means your organization needs a way to know an update happened and to assess it before trusting the new behavior.
A vendor pushing a model update without telling customers is not unusual in consumer software, where a slightly different recommendation is a minor inconvenience. In a GxP context, a silent shift in behavior means your organization is relying on evidence, the original validation, that no longer describes what the system actually does.
Ask for advance notice before a material model update, access to whatever the vendor can share about what changed, and a defined window to assess the update before it reaches your production environment. Not every vendor will agree to all of this, but it is a reasonable ask for any tool touching GxP decisions.
Even with a cooperative vendor, the assessment of whether an update is acceptable for your use case is your organization's call, not the vendor's. A model update that is fine for one customer's use case can be a problem for another's, depending on what decision the output feeds into.
A short walkthrough of how GxPForge keeps traceability current as your team works, instead of reconstructing it before a release.
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