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.


Increase productivity and reduce compliance risk with a commercially focused integrated eQMS/RIMS suite
In today's fast-paced and highly regulated environment, legacy quality management systems (QMS) and point solutions with limited functionality fall short in addressing the complexities of quality compliance and rapid business changes. To achieve exceptional quality, a comprehensive, advanced QMS designed specifically for life sciences is essential. This system should integrate solutions, leverage AI for enhanced efficiency and accuracy in practical use cases. As a company’s opportunities and challenges vary with product offering, therapeutic area and global footprint, the combination of credible, experienced consulting services alongside a QMS technology offering makes IQVIA uniquely placed for industry.
IQVIA’s SmartSolve® eQMS for life sciences is an award-winning platform that is built on four key pillars: Quality and Regulatory Compliance, Digital Content Management, Quality Management and Supplier Quality Management. Powered by Microsoft Azure, it leverages the latest in AI, analytics, and automation to enhance operational efficiency and ensure global compliance.
The QMS solution offers 19+ end to end, modular and scalable solutions designed for the specific requirements of life sciences regulations and associated manufacturing/product controls, including US 21 CFR, ISO 13485, EU MDR, MDSAP, GxP, and EU IVDR. Whether looking for a point solution or the scalable benefits of a comprehensive offering, IQVIA can support through offering QMS modules including audit, CAPA, Non conformance, document management, change management, training management, supplier control, complaint management, and post market surveillance.
Whether you need to enhance post-market surveillance or use digital tools for complaint management and adverse event reporting, IQVIA’s end-to-end eQMS can support your company throughout product life-cycle management.
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.
Hannah Seevaratnam
Vice President, Quality and Regulatory, Robling Medical
IQVIA SmartSolve for Quality, IQVIA RIM Smart for Regulatory, and IQVIA Vigilance Platform for Safety are the only intelligently connected integrations of quality, regulatory, and safety processes designed specifically for life sciences.
Automate a single process or optimize your entire quality management system to improve efficiency, accelerate regulatory approvals, and simplify global control.
Million users globally
Million complaints managed
Million certifications conducted
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.
Hear our experts discuss ways in which risks associated with AI can be reduced and regulatory systems potentially be improved.
Learn what role technology (including AI) can play in supporting quality and regulatory teams to enhance their daily performance.
Discover how AI-powered eQMS solutions are transforming MedTech and Pharma by enhancing compliance, product quality, and patient safety.
Uncover how Generative AI could be your solution to tackle the mounting challenges in safety, regulatory and quality management and achieve the next level of maturity for AI in your organization.
AI advancements in the life sciences industry have led to rapid progress and emerging challenges, prompting regulatory bodies to update regulations to address new risks. Early integration of quality assurance and regulatory affairs (QARA) professionals in medical device development is crucial for navigating evolving global regulations and cybersecurity threats.
Discover how the right eQMS empowers businesses to take a proactive approach to quality and compliance processes.
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.