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.
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 JOBSCFR Part 11 of Title 21 of the Code of Federal Regulations; Electronic Records; Electronic Signatures sets forth the requirements for the creation, modification, maintenance, archival, retrieval, and transmittal of electronic records, and also the use of electronic signatures when complying with the Federal Food, Drug and Cosmetic Act or any other Food and Drug Administration (FDA) regulation. These rulings became law in March 1997. Since that time, both industry and the FDA have been working to interpret the meaning and intent of Part 11, especially as technology is evolving. The IQVIA SmartSolve team is continuously monitoring the opinions of the FDA and furthering discussions with them as new technology and capabilities evolve, to ensure continued compliance support with the requirements. This whitepaper includes IQVIA SmartSolve®’s Position Regarding 21 CFR Part 11 Requirements.
Meet the challenge of changing stakeholder demands and increasing cost constraints with IQVIA's integrated technology services and analytics-driven offerings.
From manufacturing oversight to regulatory requirements, manage quality across your organization with a single enterprise software solution.
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.
