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.
Learn more
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
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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Reimagine clinical development by intelligently connecting data, technology, and analytics to optimize your trials. The result? Faster decision making and reduced risk so you can deliver life-changing therapies faster.
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Generate and disseminate evidence that answers crucial clinical, regulatory and commercial questions, enabling you to drive smarter decisions and meet your stakeholder needs with confidence.
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Orchestrate your success across the complete compliance lifecycle with best-in-class services and solutions for safety, regulatory, quality and medical information.
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When your destination is a healthier world, making intelligent connections between data, technology, and services is your roadmap.
TECHNOLOGIES OVERVIEWExplore our library of insights, thought leadership, and the latest topics & trends in healthcare.
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By making intelligent connections between your needs, our capabilities, and the healthcare ecosystem, we can help you be more agile, accelerate results, and improve patient outcomes.
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Building on a rich history of developing AI for healthcare, IQVIA AI connects the right data, technology, and expertise to address the unique needs of healthcare. It's what we call Healthcare-grade AI.
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The IQVIA Human Data Science Cloud is our unique capability designed to enable healthcare-grade analytics, tools, and data management solutions to deliver fit-for-purpose global data at scale.
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The IQVIA Innovation Hub connects start-ups with the extensive IQVIA network of assets, resources, clients, and partners. Together, we can help lead the future of healthcare with the extensive IQVIA network of assets, resources, clients, and partners.
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IQVIA Decentralized Trials deliver purpose-built clinical services and technologies that engage the right patients wherever they are. Our hybrid and fully virtual solutions have been used more than any others.
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Empowering patients to personalize their healthcare and connecting them to caregivers has the potential to change the care delivery paradigm. IQVIA and Apple are collaborating to bring this exciting future of personalized care directly to devices patients already have and use.
LEARN MOREOur mission is to accelerate innovation for a healthier world. Together, we can solve customer challenges and improve patient lives.
LEARN MORECareers, culture and everything in between. Find out what’s going on right here, right now.
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"Improving human health requires brave thinkers who are willing to explore new ideas and build on successes. Unleash your potential with us.
SEARCH JOBSEmployees often know little about product liability and the role they have in the company’s overall risk profile. The acts or omissions of even one employee can have severe financial and operational consequences for companies. Risk-based employee training is essential to bridging the awareness gap.
Since the adoption of ISO 13485:2016, life sciences manufacturers have continued to step up their risk-based training requirements. How does your organization currently define training requirements? If you’re not considering risk as you define them, you will need to add this consideration into your process.
For life sciences manufacturers, the product design and the development of the manufacturing process will yield critical steps that need to be defined because they impact the quality of the process and/or the safety and performance of the product.
Determining Training Requirements
When determining the training requirements for these process steps, you will benefit from analyzing:
Training requirements and effectiveness checks should be proportionate to the risk associated with the work.
Does your business associate the risk for both role-level training and for job-specific requirements?
The answer would be “it depends.” If someone has the role of a “Qualified Person,” who is signing off on a batch release, or if a Quality Manager is signing off as a CAPA approver, these roles have a risk associated with their job activities.
How is that risk accounted for in the respective training requirements?
A specific lab test that a lab technician needs to run for a product may have a unique risk depending on the specific product and/or process criticality; therefore, a specific training document or lab procedure may be linked to a critical characteristic that has a specific risk value.
Finally, how will your organization capture this information and link it to objective evidence required for the competency of each role and/or requirement? Consider seeking a training management system that includes data capture capabilities and dashboards to provide you enterprise-wide visibility into training gaps, completion, and history.
Risk-based quality processes and training requirements are key elements within ISO 13485:2016. So, how can you keep both new and long-time employees up to date on product liability issues and make sure they understand that risk management and regulatory compliance are everyone’s responsibility? If you don’t have a plan for this, now is the time to act.
Adopt an automated training management system along with other internal continuing education efforts to ensure a skilled and compliant workforce, enabling you to increase productivity, reduce job quality issues, and maintain compliance with industry regulations. SmartSolve® QMS from IQVIA contains out-of-the-box best practices for:
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.
IQVIA RIM Smart. Intelligence, automation and integration.
Discover how AI and ML reduce risk and increase efficiency in adverse event reporting
From manufacturing oversight to regulatory requirements, manage quality across your organization with a single enterprise software solution.
Automate and standardize your regulatory management, from correspondence and commitments to registration and tracking.
IQVIA Vigilance Platform is our secure SaaS environment built to simplify safety and PV processes, while boosting speed, accuracy, and efficiency.
Harness the power of automation to execute streamlined end-to-end safety solutions while reducing costs.
Meet the challenge of changing stakeholder demands and increasing cost constraints with IQVIA's integrated technology services and analytics-driven offerings.
