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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SEARCH JOBSThis past June, presenters at the IQVIA Virtual Fusion 2023 customer conference explored the transformational uses of artificial intelligence (AI) powered technologies and IQVIA’s Connected Intelligence (CI) platform within the life science industry. They presented the audience with ways these tools can empower professionals within quality to create positive, beneficial shifts to meet their organization’s ever-changing needs.
The Quality Breakout Session showcased updates within IQVIA’s Quality Management System (QMS), providing the audience with insight into quality management within the life science industry.
At Fusion 2023, organizers and participants explored the benefits of CI in an integrated end-to-end quality management system (QMS) with real-time mechanisms for monitoring, recording and measuring in-process, self-directed adjustments. The conversation centered around the need for a QMS, which can make decisions to improve cycle-times, prevent issues and downtime and ensure unsafe products don’t enter the supply chain while promoting innovation, performance and compliance.
As health authorities’ regulatory requirements are updated, an integrated QMS can initiate and manage those changes resulting in streamlined processes across Quality and Regulatory. Additionally, this integration allows a QMS to share information with regulatory management systems eliminating rework and duplication by having a single repository of approved content.
A fully integrated QMS streamlines quality workflows and automation, identifies nonconformities, and manages audits, supplier interactions and design controls. An efficient QMS automatically receives identified events or actions for review and approval and progresses them through the workflow as required.
Adapting a QMS that leverages human-like intelligence through capabilities such as vision, speech, language, knowledge and search abilities provides valuable solutions to improve quality management. AI and machine learning (ML) can accelerate innovation in QMS. AI translation capabilities can translate text instantly or in batches across a hundred languages and enables an enterprise-grade conversational AI bot to provide answers using natural language processing (NLP).
IQVIA also unveiled updates to its QMS, SmartSolve, which aim to accelerate user adoption, reduce internal training costs, improve cross-functional collaboration, provide needed accessibility, optimize by persona and build end-user productivity and ownership.
This update also details the roadmap for the SmartSolve product and goals throughout the next few years. Specifically, there is an emphasis on complaint management, requiring updates with regards to changing regulatory guidance across the globe. Additional updates include third-party document viewing, signoff and collaboration as well as risk management and analytics updates.
By increasing the efficiency and capability of this platform, organizations will be able to leverage an end-to-end system to improve compliance.
Organizers also highlighted new developments in vigilance and how these impacts will affect QMS such as SmartSolve. Within the European Union and European Economic Area, a new Manufacturer Incident Report will be published, which includes a date of reportability, unique device identification, market distribution of device and number of incidents. These updates will be incorporated into the SmartSolve platform to ensure compliance in the European markets.
In the U.S., the Federal Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) are planning to transition to electronic pre and post market Individual Case Safety Reporting (ICSR). This new standard means that SmartSolve’s platform will be gathering requirements in preparation for implementing electronic submission to FDA systems.
Finally, international quality risk management guidelines from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (IHC) place an emphasis on hazard identification as opposed to risk identification and the formality of quality risk management. Therefore, if the risk is considered higher, the formality of quality risk management should be taken into greater consideration.
Enhancements in SmartSolve in the coming year will reflect these updates and will accommodate the requirements of these international bodies.
For more information on Fusion, visit the Fusion Event page and for more information around IQVIA’s Connected Intelligence platform, visit the Connected Intelligence page. For additional questions, or to inquire about future Fusion events, please contact fusionevent@iqvia.com.
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.
From manufacturing oversight to regulatory requirements, manage quality across your organization with a single enterprise software solution.
Meet the challenge of changing stakeholder demands and increasing cost constraints with IQVIA's integrated technology services and analytics-driven offerings.
