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 demoComputer system validation is documented proof that a system does what it is meant to do, reliably, inside a regulated process. For a QA director, it means every requirement traces to a test, every test traces to evidence, and that chain holds up when an inspector asks to see it.
The scope is wider than most teams assume when they first hear the term. Any system that touches GxP data or influences a GxP decision is in play. That covers the obvious cases, a LIMS, an MES, an eQMS, a calibration system. It also covers the less obvious ones, a spreadsheet used to track deviations, a reporting tool pulling from a validated database, and increasingly, an AI tool reading records or flagging results for someone to act on.
A useful test is whether the output of the system feeds a decision that affects product quality, patient safety, or the accuracy of a regulated record. If the answer is yes, someone has to be able to show that the system was tested against its intended use before it went live, and stayed that way afterward.
Traditionally the work moves through a fixed sequence. User requirements come first, then functional and design specifications, then installation, operational, and performance qualification testing, each stage reviewed and signed before the next one starts. The whole point of the sequence is traceability, so that years later, an auditor can pick any requirement and follow it all the way to the test that proved it works and the signature that approved it.
In practice, the chain frays. Requirements get added mid project without a paper trail. Test evidence sits in someone's inbox instead of the record. A signature is missing because the approver was on leave the week the release went out. None of these gaps are dramatic on their own, but an inspector only needs to find one to lose confidence in the rest.
A feature changes after go live and the requirement document is never updated to match it.
A test ran, but the screenshot or output that proves it ran was never filed with the record.
A record is approved out of sequence, or by someone without the authority to approve it.
FDA's Computer Software Assurance guidance pushed the conversation toward assurance activities scaled to risk, rather than scripted testing for every function regardless of how minor it is. The intent is to free up effort for the systems that actually matter and let unscripted, critical thinking based testing cover the low risk ones. It does not remove the need for a defensible chain of evidence, it changes how thick that evidence has to be for a given system. See our compliance controls page for how this plays out in practice.
A model that summarizes a batch record or flags an anomaly is still a system influencing a GxP decision, and it still needs a validation story. The added wrinkle is that the model's behavior can shift as it is retrained, which the traditional fixed sequence was never built to track. Compliance teams evaluating an AI vendor should ask the same question they ask of any vendor, and one more besides, whether the tool itself has been through a validation process a customer can inspect.
No. GAMP 5 sorts software into risk categories, and the depth of testing and documentation scales with that category and with the risk the system poses to product quality, patient safety, and data integrity. A configured off the shelf tool does not need the same package as custom code controlling a manufacturing step.
FDA's authority sits with the regulated company, not the vendor. A vendor can supply release documentation, test evidence, and a validation package to support your work, but the obligation to show the system fits its intended use stays with your organization.
Yes, if it touches GxP records or influences a GxP decision. Any vendor selling into this space should be able to answer how their own platform is tested, how changes are controlled, and what evidence they can hand over to support your assessment of it.
A short walkthrough of how GxPForge keeps traceability current as your team works, instead of reconstructing it before a release.
Book a demo