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: 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 strong leadership and problem-solving capabilities. She played a key role in executing a swift vendor transition, identifying and onboarding a new, qualified 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, global quality teams, and both the outgoing and incoming vendors. This approach fostered trust, managed expectations, and ensured a collaborative environment essential for re-implementation efforts.
The two-month transition required strategic re-planning and agile execution to maintain project momentum and minimize operational disruption. Throughout the project—and especially during the vendor transition—Allison maintained an unwavering focus on project objectives, ensuring that all decisions and actions aligned with the overarching goals.
MEANINGFUL RESULTS:
The successful deployment of the global eQMS—despite significant challenges—led to improved regulatory compliance, streamlined quality processes, and increased operational efficiency across the organization.
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Enhanced Timeliness: Reduced quality workflow cycle time from 30 to 21 days
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Increased Efficiency and Compliance: Streamlined processes, reduced manual effort, and decreased headcount by four full-time employees due to system automation
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Improved Data Integrity and Traceability: System-based reporting enhanced audit readiness and ensured consistent practices across all locations
The successful completion of this challenging project under Allison’s leadership significantly strengthened the company’s global quality infrastructure and positioned it for continued success in the highly regulated clinical trial supply industry.