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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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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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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IQVIA enables genomic research via global access to a network of genomic-clinical data, proprietary technologies that enable federated analytics, and therapeutic area & bioinformatics expertise to help you answer your most pressing research questions.
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SEARCH JOBSCorrective and Preventive Action (CAPA) systems provide a wealth of information regarding the quality of a product or process. However, few companies fully leverage the power of this tool to realize its positive impact to the bottom line.
For instance, it is not uncommon for a CAPA to be initiated for each product quality-related complaint regardless of scope or severity. Over time, the system becomes laden with records of varying degrees of severity, which are often vetted by issuance order for aging reasons, rather than priority. As a result, the organization cannot optimally allocate resources to correct events that have the most impact on the business as a whole.
So then, how can a company reclaim efficiency and perhaps even streamline the CAPA process?
First, while it must be noted that there is no standard definition for risk that can be applied across organizations, the common goal is to mitigate risk, and for those that cannot be eliminated, to reduce them to a level as low as reasonably practicable.
Many companies spend plenty of time and money putting risk metrics in place that are at best subjective based on their level of tolerance.
This leads to inconsistency in the response to negative events. By quantifying risk, companies can more quickly realize a return on investment for their preliminary data gathering and work during the CAPA process.
Risk assessment (or impact assessment) is required for any CAPA process and involves the identification, analysis, and prioritization of risks, and the subsequent application of effort to minimize, monitor, and control the probability and/or impact of a negative outcome.
You can conduct your assessment by building a simple CAPA risk matrix following these three steps:
This CAPA risk matrix becomes a tool that allows you to determine the corresponding actions to events based on those criteria, including no action if it falls within the acceptable risk category.
Further, for an event that required action based on its risk rank as defined by the matrix, an effectiveness review becomes more analytical since a new severity (in light of mitigation strategy employed) and frequency can be measured to produce a follow-up ranking.
In life sciences, where patient safety is foremost, quality-related risks must be addressed swiftly and systematically.
Use of a matrix approach can, therefore, allow certain activities to be triggered automatically based on risk such that the quality of the product is adequately protected, while resources can be returned to the business of innovation and helping patients.
By quantifying risk, companies can more quickly realize a return on investment for their preliminary data gathering and work during the CAPA process.
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.
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From manufacturing oversight to regulatory requirements, manage quality across your organization with a single enterprise software solution.
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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.
