IQVIA SmartSolve® EMQS for Life Sciences

Manage quality and regulatory compliance with an end-to-end, modular, scalable 
solution

Increase productivity and reduce compliance risk with a commercially focused integrated eQMS/RIMS suite

Audiogram

Optimize processes with IQVIA SmartSolve eQMS

Mike King, Senior Director of Product and Strategy, IQVIA, discusses how a company of any size can benefit from deploying an eQMS software solution built specifically for life sciences.

Your Enterprise Quality Management System

 

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

Deliver real business impact

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.

>1.1

Million users globally

26+

Million complaints managed

37+

Million certifications conducted

eBook
Transform your workflow with IQVIA’s SmartSolve eQMS
Learn how the modular and scalable SmartSolve eQMS enhances regulatory compliance and accelerates time to market by continuously improving quality processes.

SmartSolve Frequently Asked Questions

Get quick answers about SmartSolve’s quality management solutions, features, and best practices.

SmartSolve eQMS is an Enterprise Quality Management System (eQMS) for life sciences companies. It streamlines design control, risk management, document control, audits, CAPA, nonconformance (NC), deviation handling, complaint management, and post-marketing surveillance in a validated, compliant environment—helping organizations maintain global regulatory compliance, improve quality processes, and enhance product quality.
Yes. SmartSolve includes AI and machine learning features to automate workflows, detect risks, and accelerate compliance. These capabilities reduce manual effort, improve decision-making, and enhance overall quality management efficiency for medical device, in-vitro diagnostic, and pharmaceutical companies.
No. IQVIA SmartSolve eQMS is a regulated quality management and regulatory platform for life sciences. It is not a homework or mathematics app. If you’re looking for academic tools, SmartSolve eQMS is unrelated. IQVIA’s solution focuses on design control, risk management, document control, audits, CAPA, NC, deviation handling, complaint management, and post-marketing surveillance in a validated, compliant environment.
No, that refers to a different company—SmartSolve Industries—which specializes in water-soluble packaging materials and is not affiliated with IQVIA. In contrast, IQVIA’s SmartSolve eQMS is a software solution designed for medical device, in vitro diagnostic, and pharmaceutical companies. It supports quality and regulatory compliance, streamlines operational processes, and enhances product quality.
IQVIA SmartSolve eQMS is trusted by medical device, in‑vitro diagnostic, and pharmaceutical organizations worldwide. These companies rely on SmartSolve to ensure global regulatory compliance, streamline, and automate quality processes, improve product quality, and maintain continuous audit readiness—all within a validated, life‑sciences‑focused environment.
SmartSolve supports compliance by providing validated workflows, electronic signatures, audit trails, andAI-driven insights to ensure quality management and regulatory processes.These features help organizations meet FDA, European, and other global regulatory requirements while improving operational efficiency and supporting patient safety and commercial performance.
Contact IQVIA to request a demo of our AI‑enabled, modular, and scalable Quality Management and Regulatory solution. Discover how SmartSolve uses artificial intelligence to streamline critical processes—from design and manufacturing to sales, distribution, and full lifecycle management—helping global healthcare organizations achieve compliance and operational excellence.

Industry Recognition

Explore 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.

Contact Us