-
Americas
-
Asia & Oceania
-
A-I
J-Z
EMEA Thought Leadership
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more -
Middle East & Africa
EMEA Thought Leadership
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
Regions
-
Americas
-
Asia & Oceania
-
Europe
-
Middle East & Africa
-
Americas
-
Asia & Oceania
-
Europe
Europe
- Adriatic
- Belgium
- Bulgaria
- Czech Republic
- Deutschland
- España
- France
- Greece
- Hungary
- Ireland
- Israel
- Italia
EMEA Thought Leadership
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more -
Middle East & Africa
EMEA Thought Leadership
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
SOLUTIONS
-
Research & Development
-
Real World Evidence
-
Commercialization
-
Safety & Regulatory Compliance
-
Technologies
LIFE SCIENCE SEGMENTS
HEALTHCARE SEGMENTS
- Information Partner Services
- Financial Institutions
- Global Health
- Government
- Patient Associations
- Payers
- Providers
THERAPEUTIC AREAS
- Cardiovascular
- Cell and Gene Therapy
- Central Nervous System
- GI & Hepatology
- Infectious Diseases and Vaccines
- Oncology & Hematology
- Pediatrics
- Rare Diseases
- View All
Impacting People's Lives
"We strive to help improve outcomes and create a healthier, more sustainable world for people everywhere.
LEARN MORE
Harness the power to transform clinical development
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 OverviewResearch & Development Quick Links
Real World Evidence. Real Confidence. Real Results.
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 OVERVIEWReal World Evidence Quick Links
See markets more clearly. Opportunities more often.
Elevate commercial models with precision and speed using AI-driven analytics and technology that illuminate hidden insights in data.
COMMERCIALIZATION OVERVIEWCommercialization Quick Links
Service driven. Tech-enabled. Integrated compliance.
Orchestrate your success across the complete compliance lifecycle with best-in-class services and solutions for safety, regulatory, quality and medical information.
COMPLIANCE OVERVIEWSafety & Regulatory Compliance Quick Links
Intelligence that transforms life sciences end-to-end.
When your destination is a healthier world, making intelligent connections between data, technology, and services is your roadmap.
TECHNOLOGIES OVERVIEWTechnology Quick Links
CLINICAL PRODUCTS
COMMERCIAL PRODUCTS
COMPLIANCE, SAFETY, REG PRODUCTS
BLOGS, WHITE PAPERS & CASE STUDIES
Explore our library of insights, thought leadership, and the latest topics & trends in healthcare.
DISCOVER INSIGHTSTHE IQVIA INSTITUTE
An in-depth exploration of the global healthcare ecosystem with timely research, insightful analysis, and scientific expertise.
SEE LATEST REPORTS
FEATURED INNOVATIONS
-
IQVIA Connected Intelligence™
-
IQVIA Healthcare-grade AI®
-
IQVIA AI Assistant
-
Human Data Science Cloud
-
IQVIA Innovation Hub
-
Decentralized Trials
-
Patient Experience Solutions with Apple devices
WHO WE ARE
- Our Story
- Our Impact
- Commitment to Global Health
- Code of Conduct
- Sustainability
- Privacy
- Executive Team
NEWS & RESOURCES
Unlock your potential to drive healthcare forward
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
IQVIA AI is Healthcare-grade AI
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
Meet the IQVIA AI Assistant
Your new expert analyst is here. Be at the forefront of data-driven decision-making with a new generative AI tool that enables you to interact with our products and solutions like never before. Get results you can trust, faster.
LEARN MORE
Your healthcare data deserves more than just a cloud.
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
Innovations make an impact when bold ideas meet powerful partnerships
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
Proven, faster DCT solutions
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
IQVIA Patient Experience Solutions with Apple devices
Empowering patients to personalize their healthcare and connecting them to caregivers has the potential to change the care delivery paradigm.
LEARN MOREIQVIA Careers
Featured Careers
Stay Connected
WE'RE HIRING
"At IQVIA your potential has no limits. We thrive on bold ideas and fearless innovation. Join us in reimagining what’s possible.
VIEW ROLESBlog
Transforming The Computer Systems Validation (CSV) For Your QMS Through Automation
Feb 14, 2023
As organizations strive to achieve quality maturity, achieve harmonized systems, and become leaders, computer system validation will play an unseen but integral role. Traditional Validation processes present challenges since they extend project timelines and costs, impacting TTM and resulting in the inability of Life Sciences organizations to deploy new versions of the software. Specifically, the needed relationship between requirements and tests depends mainly on diligence and expertise that is often personally held. In addition, software manual testing requires a vast amount of time and resources and is monotonous work that drives neither the worker nor the company forward.
Harmonizing systems and tools and maintaining sustainability is crucial for achieving a validated, state-of-the-art eQMS. However, this journey is complex, and organizations must overcome several key barriers to harmonization.
Barriers to Harmonization
The first of these barriers is the regulatory environment. Systems must constantly change to keep up with ever-adjusting and expanding regulatory guidelines. These changes are not localized, and organizations must adhere to any changes made globally and with each of the corresponding global regulatory bodies. In addition to the regulatory hurdles, the software constantly changes, as do the modules and functionality. Finally, there is the need to be in constant audit readiness. Additional barriers to harmonization are substandard quality or human error, operational inefficiencies, and competing priorities or resources.
Beyond Harmonization, Leading with Automated Computer Systems Validation
Some companies go beyond harmonization to achieve a leadership eQMS position driven by sustainability and continual improvement while reducing risk without extra people, time, or money. Automated Validation Script Authoring or Automated Computer Systems Validation is critical to reaching this rarefied level. ACSV enables you to streamline and manage the validation process instead of executing tedious scripts, adapting to change more efficiently and with increased accuracy while reducing risk. ACSV increases regulatory rigor while reducing timelines and human error, allowing organizations to deploy new solutions and stay up to speed with rapid technological changes.
An advancement in Automated Script Validation is Automated Validation Script Authoring, which automatically generates PQ scripts directly from user requirements.
At its foundation, Automated Validation Script Authoring relies on the ability to streamline the definition and documentation of functional requirements, defined in terms of the following:
- A visual Workflow definition to describe a business process where each block in the workflow diagram represents a Task
- A Form definition for each task in the Workflow describing the list of data elements that need to be entered when performing the Task
- Description of the Team (set of personas participating in the business process), including the Roles required to perform each task
- Description of Policies that determine conditional execution of the workflows
Similarly, user requirements that surface during the software implementation are captured as changes over functional requirements and automatically analyzed by the Script Authoring engine to compile an exhaustive series of workflow paths by exercising all discovered conditions to enforce that the script visits each task in the Workflow.
Functional and user requirements become the basis for validation scripts, which are ultimately generated using pre-defined validation templates that enforce validation standards and best practices.
Key Benefits of Automated Validation Script Authoring
- Robust, reliable, and consistent approach
- Improved efficiency in authoring validation scripts: availability and access to the finished product is not required to undertake the script authoring process
- Improved quality of the authored scripts: scripts driven directly from requirements cannot omit scenarios or assert the wrong expected results
- Improved overall validation methodology: scripts test the requirements, not the implementation of such requirements (based on a potentially wrong interpretation by the implementation team)
- Improved quality and efficiency of script execution and summary reports: automated execution removes human errors and the need to have experienced personnel with knowledge of the system executing scripts
- Improved efficiency of the very implementation: the implementation team can verify that the implementation satisfies the requirements before even delivering the implementation to the validation team for formal execution (test-driven development), reducing loops between developers and testers
- Automatically generates PQ Validation scripts directly from customer-specific requirements captured during the implementation of the SmartSolve Quality Modules.
To learn more about IQVIA’s eQMS solutions and deployment models, visit SmartSolve® Enterprise Quality Management System - eQMS Software - IQVIA, or check out the full webinar here.