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When a vendor retrains its model, who is accountable

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.

Why silent updates are the real risk

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.

What to put in the vendor agreement

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.

What your own team still owns

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.

See what a validation package looks like when it builds itself

A short walkthrough of how GxPForge keeps traceability current as your team works, instead of reconstructing it before a release.

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