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EMEA Thought Leadership
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
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Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
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EMEA Thought Leadership
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
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What makes a transformative eQMS?
Mar 06, 2024
Accelerating commercial performance while supporting the provision of safe and effective patient care
Quality management in the life sciences industry is becoming more and more complex with ever-evolving standards and regulations. Having a pro-active, digital quality management approach is being recognized a core competency and differentiator as legacy systems are holding organizations back.
“When you have end to end quality management with all the products under the same umbrella your digital transformation becomes effective, and you get an opportunity to penetrate a much larger market” Sankara Narayanan, Industry Analyst, Frost & Sullivan
A quality management system (QMS), such as IQVIA’s eQMS Smartsolve®, helps coordinate and direct an organization’s activities to meet customer and requirements, improving its effectiveness and efficiency on a continuous basis.1
In many global countries, including the the US, UK and EU implementing a QMS is a legal requirement for medical device development, and is essential for market access. ‘A robust QMS provides structure for key company processes around device safety and efficacy’.2 A transformative eQMS gives real-time visibility, supporting businesses with compliance management, quality management, digital content management and supplier quality management, enabling life sciences organizations to take a predictive and proactive approach to their quality and compliance processes.
‘Organizations that can optimize and connect their QMS will succeed moving forward.3
Some legacy systems prevent best practices and hinder real-time visibility, contributing to a lack of process organization. As well as being modular and scalable, the gold standard of quality management systems are those which integrate artificial intelligence (AI) and machine learning (ML) allowing data to be converted into actionable insights which can be used by AI augmented professionals to drive effective and efficient ways of working to enhance product quality strengthen and achieve compliance and in parallel support the commercial outcomes of an organisation. These intelligent driven solutions ensure compliance and security, help organizations overcome challenges and accelerate commercial performance.
Your QMS is as much a way of working as it is a tool for compliance. It should evolve in line with company aspirations and throughout the lifecycle of the technology.2
As well as accelerating time to market, an AI powered QMS with connected intelligence can offer proactive post market surveillance, allowing organizations to automatically mine market information, ensuring devices and products are acting as expected, so required remediations can be made, improving product safety and performance.
“With increased compliance comes better control of processes...and better provision of safe and effective care.” Mike King, Senior Director of Product and Strategy, IQVIA
Frost & Sullivan analyst, Sankara Narayanan, recently spoke with IQVIA to reveal the five most important market trends in the QMS market today and share his favorite features and functions of SmartSolve, the most complete eQMS, purpose built for life sciences. Watch now to learn more about QMS market trends and find out how a proactive digital quality management approach could be a differentiator for your organization.
References
- https://asq.org/quality-resources/quality-management-system
- https://www.digitalregulations.innovation.nhs.uk/developers-guidance/all-developers-guidance/quality-management-systems-medical-devices/
- https://www.qualitydigest.com/inside/fda-compliance-column/innovation-and-future-life-sciences-010423.html
Related solutions
SmartSolve eQMS
Connected, integrated, compliant. Build, scale, and optimize your quality and regulatory workflows with SmartSolve®, IQVIA's transformative Enterprise Quality Management System, built for Life Sciences.