SmartSolve eQMS

SmartSolve eQMS is an electronic Quality Management System developed by IQVIA, designed for life sciences organisations including MedTech, Pharmaceutical Manufacturers, and Biopharma companies. It is part of IQVIA's broader Quality Management and Regulatory Suite and is positioned to support global quality assurance and regulatory compliance processes with AI-enabled capabilities.

The platform is built to help organisations manage compliance across the full product lifecycle, reduce quality and compliance silos, and support faster regulatory approvals. It targets teams responsible for quality compliance who need scalable, integrated software to coordinate processes across global operations.

Core Capabilities

• AI-enabled compliance management to support quality and regulatory workflows
• Global scalability to accommodate multi-regional operations across markets including the Americas, Europe, Asia Pacific, and Middle East and Africa
• Integration within IQVIA's Quality Management and Regulatory Suite, which also includes SmartSolve RIM for regulatory information management
• Support for breaking down silos between quality and compliance functions across the product lifecycle
• Designed to contribute to faster regulatory approvals and market access

Target Segments

• MedTech companies requiring device-specific quality management processes
• Pharmaceutical manufacturers managing quality systems at scale
• Emerging Biopharma organisations building compliance infrastructure
• Organisations operating across multiple global regulatory jurisdictions

Platform Context and Integrations

• SmartSolve eQMS sits within IQVIA's Compliance, Safety, and Regulatory product portfolio alongside tools for pharmacovigilance, regulatory compliance, and commercial compliance
• The platform is part of IQVIA's broader technology ecosystem, which incorporates AI and machine learning capabilities described as IQVIA Healthcare-grade AI
• It can be considered alongside IQVIA's Quality Compliance services, which combine software with professional services to support integrated compliance delivery
• The system is designed to support streamlined global QA and RA processes as part of a unified Quality Management and Regulatory Suite

SmartSolve eQMS is delivered as part of IQVIA's integrated compliance offering, which combines software with expert services across safety, regulatory, quality, and medical information functions. Organisations seeking to coordinate quality management across global markets and regulatory environments can deploy it within the wider IQVIA technology and services infrastructure.