OVERVIEW:
A global clinical trial supply company, previously reliant on paper-based and fragmented quality processes across its international subsidiaries, launched a project to implement a unified Electronic Quality Management System (eQMS). The objective was to harmonize quality workflows, improve efficiency, and enhance regulatory compliance across its global operations Midway through implementation, the project encountered a major unforeseen challenge when the selected eQMS vendor was found incapable of meeting critical quality requirements. This necessitated a complete vendor change and the re-implementation of previously completed phases.
THE SOLUTION:
As the project leader, Allison Vanscoy successfully guided the team through setbacks, demonstrating leadership and problem-solving capabilities. She played a key role in executing a swift vendor transition, identifying and onboarding a new, suitable vendor to minimize risks to the organization’s existing processes. This was especially critical, given the company’s highly regulated environment. Proactive stakeholder engagement and communication were key. Allison maintained transparent and consistent communication with all stakeholders, including executive leadership, quality teams from various global locations, and both the outgoing and incoming vendors. This approach fostered trust, managed expectations, and ensured a collaborative environment crucial for the re-implementation efforts. The 2-month transition required a strategic re-planning and agile execution to maintain project momentum and minimize disruptions to operations. Throughout the project – and especially during the transition to the new vendor – there was an unwavering focus on project objectives ensuring that all decisions and actions aligned with the ultimate project goals.
MEANINGFUL RESULTS:
The successful deployment of the global eQMS, despite significant challenges, led to improved regulatory compliance, streamlined quality processes, and greater operational efficiency across the organization.
· Enhanced timeliness from 30 to 21 days: Standardized quality workflow
· Enhanced efficiency and compliance through streamlined processes, reduced manual effort and decreased headcount by four full time employees due to system automation.
· Improved data integrity and traceability through system-based reporting, enhancing audit compliance, and ensuring consistent practices across all locations.
The successful completion of this challenging project under Allison’s guidance significantly strengthened the company’s global quality infrastructure and positioned them for continued success in the highly regulated clinical trial supply industry.