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.
Book a demoAs with any vendor system, the regulated company using the tool carries the primary accountability to FDA, even when a vendor's model update is what caused the behavior shift. That does not mean the vendor bears no responsibility at all, it means the practical burden of catching and assessing the change falls on your organization first.
If a vendor's model update produces a subtly different output that later contributes to a quality issue, the regulated company will be the one an inspector asks to explain what happened and how it was caught. Contractual language with the vendor can address commercial liability between the two parties, but it does not change who FDA looks to first.
Given where accountability actually sits, a vendor's willingness to disclose model updates in advance, and to support your assessment of them, is not a courtesy, it is a practical necessity for your organization to be able to do its job. This is worth treating as a hard requirement in vendor selection, not a soft preference.
A short walkthrough of how GxPForge keeps traceability current as your team works, instead of reconstructing it before a release.
Book a demo