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
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
"We strive to help improve outcomes and create a healthier, more sustainable world for people everywhere.
LEARN MORE
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.
Research & Development Overview
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.
REAL WORLD EVIDENCE OVERVIEW
Elevate commercial models with precision and speed using AI-driven analytics and technology that illuminate hidden insights in data.
COMMERCIALIZATION OVERVIEW
Orchestrate your success across the complete compliance lifecycle with best-in-class services and solutions for safety, regulatory, quality and medical information.
COMPLIANCE OVERVIEW
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.
DISCOVER INSIGHTSAn in-depth exploration of the global healthcare ecosystem with timely research, insightful analysis, and scientific expertise.
SEE LATEST REPORTS
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.
LEARN MORE
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.
LEARN MORE
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.
LEARN MORE
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.
LEARN MORE
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.
LEARN MORE
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.
LEARN MORE
"Improving human health requires brave thinkers who are willing to explore new ideas and build on successes. Unleash your potential with us.
SEARCH JOBSOptimization of your supplier quality management processes gives you room to differentiate yourself from your competitors and gain advantages in your industry. Optimization alone, however, does not happen without regard for potential risks inherent within complex supply chains or ever-evolving regulatory requirements.
Your organization can distinguish itself from your competitors by circumventing potentially adverse situations before they become realities. Minimizing supplier-related risk will maximize your compliance and quality improvement activities, thereby growing customer trust and brand loyalty which will ultimately increase your organization’s bottom line.
You’re probably conducting incoming inspections today. Taking a risk-based approach to these inspections reduces your chances of performing unnecessary inspections and helps you identify and target items which need to be inspected most.
Implementing a risk-based sampling system (based on the criticality of risk identified in your risk files) helps you spend less time and money inspecting high-quality raw materials when you are confident that they meet or exceed quality standards. This also gives you the ability to pinpoint low performing raw materials and suppliers based on their inspection state.
A typical risk-based inspection program includes a sampling system. This consists of a sampling plan, skip lot schedule, and inspection state switching rules. If you’re thinking about implementing a sampling system for incoming inspection, these three components can provide the structure you need to get started.
Sampling plans help to define your sample size or the number of items to be inspected from each lot of incoming material. When you choose a sampling plan, like the commonly used ANSI/ASQ Z1.4, you’re setting a baseline level for the percentage of defects you’re willing to tolerate for each measured characteristic. The percentage may be 0%, which means 100% inspection for your most critical product characteristics. For less critical characteristics, you may choose a different percentage to measure (typically between 2.5-4.0%).
This level is called your Acceptance Quality Level, or AQL. Based on your AQL, the sampling plan defines how many items to inspect for a given lot size. Typically, the lower the AQL, the higher the sample size you’ll need to ensure statistical confidence in a material’s quality.
The incoming inspection sampling plan also defines how many defects are allowed for the lot to still pass inspection.
Switching rules are also based on a statistical plan that modifies the inspection schedule while maintaining confidence that incoming quality will remain high. For this reason, you should try and stick with an industry-standard plan rather than creating your own skip lot schedule.
Sampling systems may be difficult to track in a risk-based inspection environment. Industry standard sampling tables can be detailed and complex. Manual inspection management processes can make it challenging to understand each material’s quality performance over time. These factors can make it difficult to determine sample size, skip lot frequency, and switching schedules for an organization’s many suppliers and raw materials.
Fortunately, electronic Inspection Management solutions can completely automate risk-based inspection processes. Tools like SmartSolve® Supplier Quality Management from IQVIA combine industry-standard sampling systems with your ongoing supplier performance data to notify your team when inspection is needed. You can have all the benefits of risk-based inspection without the administrative and statistical headaches.
In the Life Sciences industry, compliance should be at the forefront of every incoming quality decision. Remember to consider the compliance aspects of your sampling choices. It is critical that you clearly document the sampling system you decide to use, and statistically validate the sampling system that you use. It is also important to remember that sampling systems should only be implemented if you have confidence in a supplier’s previous quality performance. Be sure that you’ve documented any audits, inspections, nonconformance history, or other records in support of this decision within your quality management system.
While the business and regulatory requirements that impact every device manufacturer’s supplier operations are growing more stringent, SmartSolve QMS provides support for the processes integral to a compliant and successful supplier quality management program. With an eco-system of supplier quality modules, SmartSolve is empowering organizations to evaluate, track, report on, and rate suppliers to tackle the challenges presented by a complex supply chain.
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.
