IQVIA’s SmartSolve enterprise quality management system (eQMS) with advanced quality management, compliance, digital content management, and supplier quality is based on Microsoft technologies that ensure enterprise level capabilities and applicability in many life sciences environments. Continuous solution updates; solution integrations with complementary IQVIA offerings; enriched user experience; and, finally, AI/machine learning – all make SmartSolve a transformative eQMS.

From a solution updates point of view, IQVIA continues to evolve and expand SmartSolve’s capabilities to meet the demands of the industry.  This is evident with the recent addition of risk and design control modules, which became even more pertinent to quality management with the advent of the EU Medical Device Regulation. Additionally, EU MDR drove the need for a compliance-driven module; post-market surveillance for medical-devices. Through regular updates, IQVIA’s SmartSolve offers customers one of the broadest, deepest quality management solution footprints in the industry. While the company offers customers such a broad set of quality management solutions, it promotes efficiency and value with connectivity within the SmartSolve QMS modules but also to other IQVIA solutions. For instance, SmartSolve’s tightly integrated modules increase efficiency, and its design facilitates seamless data coordination, connectivity, and integration across different enterprise systems such as ERP, MDM, LABS, PLM, SCM, MES, and HRM used by customers. However, that connectivity extends to Regulatory Intelligence and RIM solutions which historically have existed in isolation from QMS.

The company offers outstanding user experience with a commercial grade UI for improved user acceptance, productivity and efficiency for life sciences organizations. For instance, IQVIA has a dedicated UI design team that brings together conceptual, interaction, and visual design into SmartSolve, to increase user adoption, efficiency and productivity, and providing users a similar experience across all IQVIA products. In addition, IQVIA adds automation, with AI/ML, and other advanced capabilities to accelerate the cycle time of users’ workflow and increase the accuracy, efficiency, and productivity of their tasks by providing recommendations. For example, a common use case for the conversion from transactional to transformational is that of FDA codes (which includes IMDRF coding) for adverse event reporting to the FDA. IQVIA has taken the volume of existing coding and descriptions of events and built a machine learned (ML) model. So, when a user presents a new adverse event, the description (processed by NLP) will prompt a recommendation regarding the correct classification of the FDA code, although it is the end user who will make the final decision on the code. In true ML fashion, this reinforces the consistency of reporting, as the model also learns from the users it suggests to.

IQVIA also offers the capability of Connected Intelligence because in today’s businesses there is a lot of data, however, actionable intelligence is not always available.  This complicates timely and accurate decision-making and forces most organizations from the MedTech and Pharma industry to spend a large percentage of their time on operations and less time on strategy. With IQVIA’s intelligent automation and AI methods, life sciences organizations have the opportunity to spend less time on operations and more time on strategy & innovation, lowering operational costs and complexity, and improving efficiency, productivity, quality, and compliance levels.

In bringing innovative solutions to life, IQVIA not only forecasts the needs of the market but also considers the needs of its customer community. For instance, SmartSolve’s roadmap drivers include not just regulatory concerns and innovation, it also includes the voice of the customer through their product advisory boards, focus groups, user groups, and conferences.  In addition, the company provides customers with industry updates through quarterly newsletters, customer knowledge transfer sessions for new functionality, and customer workshops. IQVIA is a Supporting Organization member of MedTech Europe, the European trade association for the medical technology industry including diagnostics, medical devices and digital health. What further differentiates IQVIA from some of its competitors that offer only solutions is that IQVIA provides customers with both solutions (i.e., SmartSolve eQMS platform technology) and comprehensive QMS consulting services, which advance a customer’s quality maturity from the stage of development to that of successful leadership. To this end, the company’s consulting services include organizational change management, mock inspections and audits, system enhancements and support, and verification and validation services.

Overall, IQVIA SmartSolve, enabled and powered by ongoing solution updates, solution connectivity, user experience, and AI/ML provide life sciences companies with a purpose-built, transformative, comprehensive, and advanced QMS.

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