Quality & AI
Quality & AI
Enterprise AI. Human sign-off. Inspection-ready quality.
100% Human Sign-Off
Every quality-critical output reviewed and approved by a qualified person. AI assists. Humans decide.
Pseudonymised Patient Data
Pseudonymised patient data flows through AI for signal detection, safety monitoring, and analytics. Connected to trial databases. DPA and GxP compliant throughout.
Enterprise-Grade AI
BAA-covered. SOC 2 Type II. Enterprise API subscriptions. Pseudonymised data pipelines with GxP validation.
10x Faster Document Production
AI accelerates template-driven drafting. Automated QC catches errors manual review misses.
24/7 Regulatory Monitoring
Continuous scanning of MHRA, FDA, EMA, ICH, and EU AI Act. QMS updates proactively, not reactively.
92+ QMS Documents
30+ SOPs, 17 flowcharts, 37+ tools, 8 policies. Inspection-ready from day one.