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 demoA diagnostics company often carries obligations from two directions at once, GxP requirements for the systems supporting manufacturing and quality, and device level scrutiny if the software itself is part of the diagnostic. Knowing which line a given system sits on shapes how it gets validated.
A LIMS tracking sample results for internal quality purposes is a fairly standard CSV problem. Software that interprets a test result and presents a diagnostic conclusion is a different animal entirely, closer to Software as a Medical Device territory, with its own regulatory pathway layered on top of general GxP expectations.
A tool built for internal use sometimes evolves into something customer facing without anyone revisiting which regulatory category it now falls under. An algorithm that started as an internal quality check can end up influencing an actual diagnostic output, at which point the validation bar it needs to clear has moved considerably.
For any system touching sample data or test interpretation, ask plainly whether its output ever reaches a diagnostic conclusion a clinician or patient relies on. That single question usually settles which validation path applies, standard CSV or something closer to device level scrutiny.
A short walkthrough of how GxPForge keeps traceability current as your team works, instead of reconstructing it before a release.
Book a demo