This document describes IQVIA’s modular, scalable eQMS for quality, regulatory, and safety. It offers components for CAPA, risk management, complaint handling, design control, labeling, and vigilance. Use cases include global change control and scaling solutions for startups, enabling operational efficiency and compliance. With integrated intelligence, it provides a single source of truth for global registrations, supports Health Authority interactions, and facilitates dossier compilation. The system helps MedTech companies improve patient safety, regulatory compliance, and operational efficiency.

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