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.
The requirements for supplier management and regulations regarding supplier management have recently tightened in the pharma and medical device space, and IQVIA has implemented a new SmartSolve module in response to that demand. As a critical component in the supplier ecosystem, Supplier Management is currently being implemented in earlier phases of companies’ processes.
Whether from ISO standards, medical devices or pharmaceutical regulations, the different authorities all have specific requirements for approving, monitoring, and re-evaluating suppliers. These requirements apply to the quality of purchased products and services, supplier non-conformances, CAPA, and risk. The Supplier Management module applies to several segments of the supplier management vetting and onboarding process.
Supplier Management starts with identified potential suppliers for evaluation, using enterprise resource planning (ERP) and supply chain systems. Once prospective providers are identified, the evaluation process is initiated in SmartSolve.
On approval (or rejection), the supplier’s status gets updated to the ERP. Approved suppliers are then assigned to the approved list. The SmartSolve module allows for the inclusion of a supplier's supply chain, which is a requirement in pharma.
While Supplier Management plays a primary role in maintaining and monitoring suppliers, other systems participate in this process. For example, Audit Management participates by auditing supplier sites and their QMSs. When incoming purchases are inspected as part of the process, the supplier ratings are updated, and nonconformances and CAPAs registered against the supplier.
The supplier rating is a composite rating set up with a waiting system controlled by the organization. Companies can build additional KPIs and metrics through quality intelligence. Suppliers can participate in their evaluation and onboarding processes, or respond to CAPA's, NCS, audit findings, and actions.
In the Supplier Management module, an organization evaluates, approves, monitors, and measures potential suppliers. Not only does the Supplier Management module perform initial evaluation tasks such as reviewing certifications, QMS quality policy, and kicking off supplier audits, it also allows for periodic reviews. When necessary, it performs decommissioning tasks based on the organization’s risk, supplier type, and owning site policies.
The tasks in the workflow can run sequentially, in parallel, or in a combination of sequential and parallel. Final QA decision approval is included before activation of the supplier. Finally, Supplier Management is built to integrate with other quality processes like auditing, as well as the company’s enterprise ERP or supply chain solutions.
The takeaway from all of this is that SmartSolve’s Supplier Management feature is more than just a module. It's an entire ecosystem of related and connected processes. This robust Supplier Management module offers multiple benefits for users, including:
Implementing this module enables companies to reap these benefits, remain compliant with the various standards and regulations, and improve their value and profitability.
Interested in exploring SmartSolve eQMS for your business? Reach out to us at Regulatory_Quality_Compliance@iqvia.com or visit our website here: IQVIA.com/SmartSolve.
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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