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 demoFDA's direct authority sits with the regulated company using a system, not with the vendor that built it. A vendor supplying release documentation and test evidence is providing a commercial convenience that supports your work, not fulfilling a direct legal obligation of its own to FDA.
It is tempting to treat a vendor's compliance documentation as a substitute for your own diligence, especially when the vendor markets itself heavily on compliance credentials. The obligation to show a system fits its intended use in your specific context is yours, and no vendor document transfers that obligation away from your organization.
A good vendor can supply evidence, testing documentation, a track record other customers can reference, that makes your own assessment faster and more confident. What a vendor cannot do is make the underlying assessment on your behalf, because only you know how the system is actually being used inside your specific regulated process.
When evaluating a vendor, frame the conversation around what evidence they can hand over to support your assessment, rather than asking whether the vendor itself is compliant. The second framing invites a vendor to answer a question that is not really theirs to answer.
A short walkthrough of how GxPForge keeps traceability current as your team works, instead of reconstructing it before a release.
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