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 demoCLIA, the Clinical Laboratory Improvement Amendments, governs laboratory testing performed on human specimens in the United States. It sets its own quality expectations for laboratory systems, which overlap with but are not identical to the GxP framework most manufacturing focused compliance teams are used to.
Both frameworks care about the same underlying things, documented procedures, traceable results, and systems that behave reliably. A LIMS supporting a CLIA certified lab needs the same fundamentals, access control, audit trails, and change management, that a manufacturing quality system would expect.
CLIA is oriented around laboratory testing performance and proficiency, with its own inspection process separate from FDA's GMP oriented inspections. A lab operating under both a CLIA certification and broader GxP obligations, common for labs supporting drug development, has to satisfy two sets of expectations that were not written with each other in mind.
Map which systems fall under which framework rather than assuming one validation approach covers both automatically. A system's validation package should reference the specific expectations of whichever framework, or both, actually apply to it.
A short walkthrough of how GxPForge keeps traceability current as your team works, instead of reconstructing it before a release.
Book a demo