AI-Enabled Quality and Regulatory Management:
Real-time visibility and control over quality, regulatory, and supplier processes with modular, scalable solutions.
Comprehensive Compliance Tools:
Includes Change Management, Document Management, Training Management, Registration & Submission Management, Health Authority Interaction, Publishing, Quality Event Management, Deviation & Nonconformance Management, Inspection Management.
Smart Platform Technology:
Built on Microsoft Azure AI, with advanced analytics, technical and regulatory frameworks, and SmartStudio configuration for seamless integration and scalability.
Industry Expertise:
Leverage deep domain knowledge and technology that adapts to your business needs.
Business Impact:
Drive product quality, patient safety, and commercial performance with a unified eQMS platform.
We evaluated multiple systems to ensure we chose the best fit for our needs. SmartSolve stood out due to its comprehensive features, ease of use, and robust support for compliance and reporting.
SmartSolve unifies enterprise Quality Management (eQMS) and Regulatory Information Management (RIM) on a single, secure cloud platform, streamlining compliance and accelerating product delivery.
Powered by IQVIA Regulatory Intelligence and IQVIA Vigilance Detect, SmartSolve delivers AI-driven analytics, real-time insights, and closed-loop compliance.
Built on Microsoft Azure and backed by IQVIA’s global expertise, SmartSolve helps you meet FDA, EU MDR, and ISO 13485 requirements, scale globally, and bring safer, higher-quality products to market faster.
Request a SmartSolve eQMS demo for Pharma & MedTech.
IQVIA’s SmartSolve® eQMS has been honored with a Bronze Stevie® Award for Healthcare Technology Solution, recognizing its innovative role in transforming quality management for MedTech and life sciences. Read more.
F&S awards IQVIA with Best Practices Customer Value Leadership Award in the global artificial intelligence regulatory and quality solutions space for the healthcare industry. Read more.
IQVIA’s SmartSolve eQMS is recognized for the “Best Use of Artificial Intelligence in Healthcare. Read more.
SmartSolve is recognized with Frost & Sullivan’s 2023 North American Enabling Technology Leadership Award in the QMS market for life sciences industry. Read more.
The award-winning SmartSolve eQMS for MedTech and Pharmaceutical companies enhances quality and improves regulatory compliance, enabling organizations to deliver life-changing therapies to patients faster.
Small and emerging biopharma can also be at the forefront of tech innovation by automating their quality compliance management with IQVIA SmartSolve Fundamentals.
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