Epredia Transforms Quality and Regulatory Operations with the Veeva MedTech Suite

Unified platform increases efficiency and compliance by harmonizing processes globally

EPREDIA – AT A GLANCE
  • Headquarters: Kalamazoo, Michigan
  • Therapeutic Area: Cancer Diagnostics
  • Employees: 1,200+
  • Veeva Solutions: Vault QualityDocs, Vault Training, Vault QMS, Vault Submissions, Vault Registrations

Epredia’s mission is to improve lives by enhancing cancer diagnostics. The company was established in June 2019 when the PHC Group bought Thermo Fisher Scientific’s anatomical pathology business. Epredia used this spinoff as the catalyst for a global QA and RA transformation.

At the time, each of the company’s six manufacturing sites had its own systems and processes, which created needless complexity, inconsistency, and compliance risk that together were causing delays across the product development lifecycle.

Epredia’s objective was to move from a mix of aging point solutions to a unified platform that would harmonize quality and regulatory processes globally, reduce waste, and improve efficiency.

Accelerated Rollout of a Unified Solution

After evaluating several alternatives, Epredia selected the Veeva MedTech Suite to realize its technology vision. Epredia viewed the breadth and depth of the MedTech Suite and the platform’s quality and regulatory capabilities as a key advantage. In addition, the Veeva solution met the company’s IT modernization goals, including cloud deployment, an intuitive user experience, and the ability to integrate external partners into core processes.

Epredia met an aggressive implementation timeline with a six-month rollout of Vault QualityDocs, Vault Training, and Vault RIM Submissions, which came in ahead of schedule and under budget. All Epredia sites now manage controlled documents and training on a shared global platform for greater alignment, compliance, and visibility. Plus, the regulatory affairs team can accelerate and easily track the thousands of regulatory submissions necessitated by Epredia’s name change.

The move to a cloud solution enables Epredia to simplify complexity across the total product lifecycle. This modernization effort gives Epredia the opportunity to create competitive advantage with a platform strategy that supports their accelerated growth strategy.

“Our divestiture created an opportunity to modernize and there’s a real motivating factor to move to one unified system that can scale with us as we accelerate our growth strategy.” – Mark Ramser, Senior Director of Global Quality, Epredia

Linking Quality and Regulatory Processes

Next on Epredia’s roadmap is the phased implementation of Vault QMS and Vault Registrations. Looking ahead, Epredia sees numerous opportunities to increase efficiency with a unified QA/RA environment. For example, Epredia plans to streamline change control by enabling tighter collaboration between quality and regulatory and enhance decision-making with dashboards that combine QA and RA data.

Epredia’s transformation journey is just beginning, and the company will continue to leverage the Veeva MedTech Suite to simplify its IT landscape, improve compliance, and drive operational excellence, and ultimately bring products to market faster.

Success Highlights

About Epredia

Epredia is a global leader in anatomical pathology, providing comprehensive solutions for precision cancer diagnostics and tissue diagnostics. Powered by key brands, including Erie Scientific, Menzel-Gläser, Microm, Shandon, and Richard-Allan Scientific, Epredia’s portfolio includes microscope slides, instruments and consumables. Epredia has major sites in the United States, the United Kingdom, Germany, Switzerland and China.

To learn more, our recent whitepaper, Harmonizing Quality and Regulatory to Streamline and Speed MedTech Product Lifecycle, details how medtech leaders like yourself can deliver higher quality products to market faster while improving the bottom line.