Global Quality Transformation: How Epista Enabled Sobi to Successfully Implement Veeva QMS

Intro

In 2022, Sobi initiated a strategic effort to implement Veeva QMS - a unified, cloud-based quality management system - to replace its legacy tools and improve operational oversight. The goal was clear: build a globally harmonized system to manage core quality processes and support collaboration across affiliates, external partners, and suppliers.

However, the project came with several complexities:

• Simultaneous projects: Several Veeva systems were being implemented in parallel across the organization.

• Integration into live systems: QMS needed to integrate with the already live Quality Suite and the RIMS Suite.

• Data migration: A complex data landscape with multiple source files, inconsistent formats, and the need for careful mapping and transformation.

• Resource intensity: A small number of key resources were required to drive high engagement over an extended period (~2 years).

• Agility & customization: As a virtual company with outsourced manufacturing, Sobi needed tailored processes that balanced Veeva’s out-of-the-box features with its unique business needs.

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Scope and Approach

The global project was divided into two strategic phases:

• Phase 1 focused on core quality processes: Deviations, Complaints, CAPA, Change Control, Audits, Inspections, and Continuous Improvement.

• Phase 2 introduced Supplier Qualification Management.

To streamline implementation and shorten the timeline to go-live, the team focused initially on processes tied to the legacy system—enabling early decommissioning and full data migration.

Solution

A key success factor was building a strong core team, kept deliberately small to remain agile and efficient. Subject Matter Experts (SMEs) were brought in on an ad-hoc basis, while dedicated workstreams handled training, cutover, and data migration. This structure reduced meeting overload and ensured focused execution.

Other critical enablers included:

• A clearly defined global process ownership model to drive decision-making and accountability.

• An organizational change management lead with a structured communication and training plan.

• Strategic alignment with parallel Veeva projects for optimized implementation.

• A dedicated data migration workstream, applying a risk-based approach and leveraging Epistas expertise to reduce internal workload and enhance accuracy.

Epista’s Contribution

Throughout the project, Epista acted as a strategic bridge between Sobi and Veeva, bringing deep expertise in both Veeva’s platform and Sobi’s unique business processes. With multiple Veeva projects running in parallel, Epista’s holistic understanding of the broader landscape ensured alignment across initiatives and prevented duplication or conflict.

As a trusted companion throughout the journey, Epista enabled Sobi to make well-informed, timely decisions—whether related to configuration, process alignment, data migration, or system integration. Their role extended beyond technical guidance: Epista became a central point of continuity, helping to translate business needs into system capabilities and ensuring all implementation activities stayed true to Sobi’s strategic objectives.

Key areas of contribution included:

Strategic Guidance & Project Integration: Ensuring decisions were aligned with both Veeva capabilities and Sobi’s other ongoing digital initiatives.

Configuration Support: Advising on best practices and balancing out-of-the-box functionality with Sobi-specific customizations.

Communication & Alignment: Acting as a central voice across stakeholders, Veeva, and internal teams to ensure clarity, consistency, and progress.

Training & Adoption: Developing training materials, guiding super users, and supporting change management efforts.

Quality & Compliance: Supporting validation, risk assessments, and documentation to meet internal and external compliance standards.

Data Migration Oversight: Providing both strategic direction and hands-on support to ensure a smooth, compliant migration of complex datasets.

Thanks to Epista’s experience, cross-functional understanding, and collaborative approach, Sobi was able to navigate the complexity of a multi-year, global implementation with confidence and clarity.

Results

Sobi is now live with a global, integrated solution supporting around 500 end-users, managing all core quality processes in a single, user-friendly platform. Outcomes include:

• A decommissioned legacy system, with all critical data securely and accurately migrated.

• Real-time dashboards and improved reporting, enhancing decision-making and compliance.

• A strong governance model ensuring sustained process ownership and system adoption.

• Significant progress toward Sob’s long-term vision: ONE DIGITAL PLATFORM.

This new platform replaces multiple disconnected systems, integrating quality, regulatory, and clinical data. It enables faster onboarding of new development projects, streamlined collaboration, and end-to-end visibility across product lifecycles.

Next Steps

The digital quality journey continues, where Sobi is exploring:

• Batch release functionality

• Seamless integration across all Veeva Vaults, further connecting regulatory and clinical data with quality operations.

Customer quote from Petter Gallon, Director Global Quality Systems at Sobi Global GxP Compliance & Quality Systems department who acted as the Functional lead and acting system owner/business process owner throughout the project.

“Having completed the project, I can confidently say it was in safe hands. Epista’s knowledgeable resources and extensive experience with similar projects proved invaluable.”

Conclusion

This case is a strong example of how expert consultancy and collaborative execution can drive success in a complex, global implementation. Through careful planning, agile execution, and deep expertise in Veeva and life sciences, Epista empowered Sobi to modernize quality operations and lay the foundation for scalable, compliant, and connected digital capabilities.

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