SmartSolve eQMS

IQVIA's SmartSolve eQMS is an AI-driven Enterprise Quality Management System designed specifically for the life sciences sector. It optimizes and streamlines quality management and compliance by integrating various functions and leveraging AI for enhanced efficiency and accuracy. This comprehensive platform is modular and scalable, allowing companies to manage regulatory requirements, adhere to standards such as US 21 CFR, ISO 13485, EU MDR, MDSAP, and others effectively.

The solution offers 19+ end-to-end modules addressing aspects such as design control, document management, audits, CAPA, nonconformance handling, and post-marketing surveillance. By supporting processes like risk management and complaint management, SmartSolve eQMS ensures organizations maintain global regulatory compliance while enhancing product quality.

The platform stands out due to its integration of quality, regulatory, and safety processes, providing intelligently connected solutions that enhance operational efficiency and simplify global control. Powered by Microsoft Azure, it utilizes the latest in analytics and AI technologies to support companies in achieving regulatory compliance, accelerating innovation, and ensuring patient safety.

IQVIA's solution is trusted by medical device, in vitro diagnostic, and pharmaceutical companies worldwide. It is designed to address the needs of both large and small enterprises by offering scalable benefits and enabling businesses to remain audit-ready continuously.

Key Features

• AI and Automation: Reduces manual efforts and improves decision-making through AI-driven insights.
• Global Compliance: Ensures satisfaction of FDA, European, and other international regulatory requirements.
• Integrated Modules: Offers capabilities across multiple areas like risk management, complaint handling, and surveillance.
• Scalable Design: Modules can be adapted to various organizational sizes and needs.

Recognized for its impact on healthcare technology, SmartSolve eQMS has received several industry awards, acknowledging its innovation in MedTech and life sciences. IQVIA supports companies in transforming their quality processes effectively and efficiently, enhancing their ability to bring life-changing therapies to patients more rapidly.