GxP Validated

Built to meet GxP standards for clinical trial environments

When it comes to clinical trials, innovation is only valuable if it’s validated and compliant. That’s why clinicallabel.io is more than a tech solution — it’s a GxP-compliant platform, rigorously tested and maintained to meet the highest standards in the pharmaceutical industry.

From infrastructure to user interface, every component of our system has been designed, tested, and documented under a robust validation lifecycle. We follow industry best practices for Good Automated Manufacturing Practice (GAMP 5) and 21 CFR Part 11 to ensure our platform meets the strictest regulatory expectations.

Need to conduct your own internal validation? No problem. We’ll share our validation protocols, test plans, and test results to streamline your process. Want to re-validate under your internal QMS? We support that too — with reusable assets and cooperative documentation every step of the way.

Why It Matters

A validated system reduces regulatory risk, increases audit readiness, and ensures patient safety. Sponsors need confidence that any tool used in clinical trials is fit for purpose, tested, and maintained under change control — and that’s exactly what clinicallabel.io delivers.
We maintain an active Quality Management System (QMS) that governs every release, from change request to deployment, and all updates are tracked, tested, and documented. We even share our change controls with our customers — because transparency is part of our compliance promise.