Modicus Prime Information

The Problem: FDA observations and warning letters for Inappropriate AI Usage are reshaping how pharmaceutical manufacturers validate and maintain AI systems. Organizations are struggling to scale AI into GxP environments, validate AI systems and suppliers, maintain AI Audit Readiness, meet auditor expectations, and keep up with evolving regulatory expectations. Our Platform: We ensure pharmaceutical companies’ AI applications are audit-ready with the AI Management System. The system integrates with QMS & data science tooling for AI validation, AI Supplier Assessments, and Context of Use management, enabling scalable AI Audit Readiness across the enterprise. Key Outcomes: • Automate validation of AI systems and AI Suppliers in GxP. • Maintain a validated state across AI application life cycles, including monitoring and change control. • Scale AI audit readiness across the enterprise. • Reduce compliance risk while improving AI ROI. • Accelerate AI adoption in GxP environments. Who We Serve: Modicus Prime actively contributes to pharmaceutical industry standards and best practices through authorship and participation in ISPE, BioPhorum, PDA, and industry conferences. CEO Taylor Chartier is a co-author of the 2025 ISPE GAMP AI Guide. Producing AI audit artifacts from data science, IT, quality, and compliance, our software ensures every stakeholder works compliantly with AI in regulated environments.