Risk-Based Quality Management (RBQM) System Capability Checklist

Navigating the RFP process for an RBQM platform can be overwhelming. This expanded checklist is designed to give you a clear, structured framework to evaluate vendors and select a solution that ensures operational efficiency, enhanced trial quality, and global compliance.

You’ll gain a comprehensive view of RBQM platform capabilities, including:

🌐 Core RBQM Capabilities: Centralized data management, risk visualization tools, and predictive analytics.

⚙️ Operational Efficiencies: Streamlined site monitoring processes and automated workflows to reduce site burden.

🛡️ Global Compliance: Built-in alignment with FDA 21 CFR Part 11, ICH E6 (R2/R3), GDPR, and regional GCP standards.

✅ Vendor Evaluation: Integration capabilities, ROI transparency, and proven vendor experience.