Outdated compliance practices aren't viable amid evolving market and regulatory changes. IQVIA’s award-winning, end-to-end quality management system streamlines the product value chain, accelerates market entry, safeguards companies and patient safety, and meets complex regulatory demands.
With this wide distribution network, Daavlin struggled with efficient document management for quality and regulatory practices. “We suffered from the same ills as other paper-based systems. Our team as spending too much time tracking down the status of document approvals and sometimes even recreating document that were lost in the process,” said Phil Reece, regulatory affairs director at Daavlin.
The company turned to IQVIA’s SmartSolve Quality Management System (QMS) to eliminate the daily headache of identifying who needed to approve documents and their status. The goal was to create better efficiency as small updates and modifications were taking months to gain approvals, which was constricting business growth while still maintaining regulatory compliance.
“We chose SmartSolve over competing solutions as it provided the potential to scale operations, rather than simply serving current needs. SmartSolve’s modular structure offers us the opportunity to adopt elements to address immediate issues and integrate further modules as need,” said Reece.
Beginning with the IQVIA SmartSolve Document Management module, Daavlin is turning from a paper-based operation to a digital system. However, the Daavlin recognized that a change overnight would not feasible. They designed an implementation plan that adopts SmartSolve’s document management capabilities gradually.Daavlin reviewing each document to ensure it is still relevant and valid, then updating it, if necessary, before uploading it. The company is also adding users as needed, which ensures essential personnel are trained first and limits the impact on day-to-day operations. “While this methodical approach will take time, it will ensure our processes are also streamlined so irrelevant information or practices are not adopted in the new system. We are running a hybrid system during this period,” said Reece.
Already, the manufacturer has found that automating its processes with SmartSolve has eliminated the need to track down documents or find lost papers and the automated audit trail gives an instant insight into all decision chains. Today, reviewers are confident that they are seeing the most accurate version of a document and any comments they make will be immediately integrated, without slowing the process down. The time needed to implement a change has dramatically decreased from months to days and further efficiencies as it expands its use to additional modules.
“Our executive team is seeing an increased speed, accuracy and auditing of information. It is only streamlining our efforts allowing us to better serve customers,” said Reece.
Looking ahead, Daavlin is planning to implement additional SmartSolve modules of Non-Conformance and Correct and Preventative Action (CAPA), Complaints, Design along with SmartSolve’s API to link to the manufacturer’s Enterprise Resource Planning (ERP) system to further streamline operations.“We only anticipate continued improvements in business performance and efficiencies to drive growth and help more people suffering debilitating skin diseases with light therapies with this transformative QMS solution,” said Reece.
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