Verixa

Verixa is an audit-defensible AI platform purpose-built for GxP-regulated teams. We automate the most error-prone parts of compliance—while maintaining full regulatory traceability. Unlike generic “AI copilots,” Verixa is engineered from the ground up to align with 21 CFR Part 11, EU Annex 11, and ICH Q9. Every recommendation, risk score, and CAPA suggestion is modular, explainable, and inspection-ready. Our platform integrates directly into QMS and regulatory workflows, powering: Deviation Intake & Triage Risk & Impact Assessment (FMEA) Root Cause Analysis (5 Whys, Fishbone) CAPA Recommendation & Tracking Audit Readiness Simulation Regulatory Q&A (FDA | EMA | MHRA) We serve biotech, ATMP developers, CDMOs, and digital health innovators managing escalating compliance complexity with lean QA capacity. Whether you're prepping for inspection, onboarding QMS at scale, or buried in Excel-based RCA chains—Verixa brings speed, clarity, and defensibility. Modular architecture – deploy one or all modules Human-in-the-loop workflows – no black-box outputs Regulatory-first design – built by GxP experts, not generalists We’re now onboarding early pilot partners in the US and EU. Verixa turns compliance into a strategic advantage. Traceable. Predictive. Inspection-Ready.