- Client Overview – A global consumer goods leader requiring regulatory compliance and system modernization
- Directio’s Role – Key contributor in project execution, compliance, and system optimization.
- Challenges – Ensuring CSV/GxP compliance, seamless migration, integration, and ongoing maintenance.
- Solution – Migration from TrackWise to Veeva with regulatory oversight and continuous support.
- Key Achievements – Compliance assurance, smooth transition, increased efficiency, and system reliability.
- Results – Improved performance, proactive maintenance, and future-proofing the QMS.
Client
A global consumer goods corporation known for its wide range of personal care, hygiene, and household products. Operating in a highly regulated environment, the company must comply with Computer System Validation (CSV) and GxP standards to ensure product safety and quality.
Directio’s Role
For many years, Directio has been an integral part of the client’s team, actively contributing to the project’s execution. We collaborate closely, consulting on key aspects, implementing planned actions, and providing expert support in quality management and regulatory compliance.
Challenge
The client needed an efficient, compliant, and scalable Quality Management System (QMS) to support its global operations. Evolving regulatory requirements and technological advancements required the migration from TrackWise to Veeva, ensuring ongoing compliance and system modernization.
The key challenges included:
- Regulatory Compliance & Audits – Ensuring the new system meets CSV and GxP standards and is prepared for rigorous government audits.
- Seamless System Migration – Transitioning from on-prem TrackWise to a modern cloud platform without disrupting global operations.
- Customization & Integration – Balancing out-of-the-box functionality with necessary custom integrations tailored to the client’s unique workflows.
- Ongoing Maintenance & Support – Providing rapid response to system issues, compliance updates, and evolving business needs.
- Continuous Improvement – Offering strategic advisory services to optimize performance, drive upgrades, and prepare for future enhancements.
Solution
Our team is an integral part of the project planning and execution team, working alongside the client’s internal experts to ensure a seamless transition, continuous compliance, and high system performance. We contribute our expertise in quality oversight, regulatory alignment, and ongoing system optimization, actively supporting every stage of the process.
The achievements of the entire team include:
Migration from TrackWise to Veeva
- Successfully transitioned the Quality Management System from TrackWise to Veeva, ensuring full compliance with CSV and GxP requirements.
- Managed seamless data migration, preserving historical records and audit trails.
- Ensured operational continuity across all global business units.
Compliance-Driven Approach
- Provided expert oversight to align the new system with audit requirements and industry regulations.
- Established robust validation protocols to meet compliance standards.
Customization & Integration
- Assisted in configuring Veeva to fit the client’s specific needs while ensuring smooth integration with other enterprise systems.
- Maintained a balance between standard functionality and necessary customizations to support business processes.
Ongoing Maintenance, Upgrades & Issue Resolution
- Actively monitor and rapidly respond to any system issues, minimizing downtime and ensuring continuous compliance with regulatory updates.
- Provide ongoing upgrades to align the platform with evolving business and compliance requirements.
Continuous Advisory
- Maintain a close partnership with the client, offering insights into best practices, system improvements, and future scalability.
- Ensure the platform remains adaptable for future regulatory and operational changes.
Results
Regulatory Compliance Ensured
- The new Veeva-based QMS passed government audits and meets all CSV and GxP requirements, securing the client’s ability to operate without compliance risks.
Smooth Transition from TrackWise to Veeva
- Successfully migrated the system without operational disruptions, ensuring business continuity across all global locations.
Increased Efficiency & Flexibility
- The new configurable platform allows the client to adapt quickly to regulatory changes and internal process adjustments.
Enhanced System Performance & Reliability
- With cloud-based scalability, the application now supports real-time global usage, ensuring consistent availability and improved performance.
Proactive Maintenance & Issue Resolution
- Through ongoing monitoring and rapid response, Directio ensures that any issues are quickly addressed, keeping the system fully operational.
Conclusion
As an integral part of the implementation team driving this significant transition, Directio has closely observed, analyzed, and supported the shift from TrackWise to Veeva. By providing regulatory expertise, technical assistance, and strategic guidance, we have helped ensure a smooth and effective transformation.
With a solid foundation now in place for ongoing maintenance, upgrades, and issue resolution, the client is well-equipped to continuously enhance and scale their Quality Management System for the future.
Looking for expert support in Quality Management System migration, compliance, and optimization? Contact Directio today to ensure seamless transitions, regulatory compliance, and ongoing system performance.
