Case Study: Netherlands Vaccine Institute achieves seamless EU GMP compliance with Sparta Systems' TrackWise

Netherlands Vaccine Institute Chooses TrackWise

The Netherlands Vaccine Institute (NVI), created in 2003 to secure vaccine supply for the Dutch population, faced growing difficulties managing the large volume of records required for EU GMP reporting. By 2008 its mix of Excel, Access and paper-based processes was no longer adequate, so NVI sought a centralized electronic document-management solution that would ensure regulatory compliance and integrate with existing systems.

NVI selected Sparta Systems’ TrackWise® for its EU-compliant reporting, multi-language support, strong integration capabilities and user-friendly interface, and worked with Sparta to implement the system on schedule. More than 20,000 documents were migrated immediately (growing to 40,000 in two years), 13 QA workflows (including deviations, CAPA, change control and audits) were deployed, and the institute gained faster, more efficient compliance processes, empowered users with dashboards and self-configuration, and reduced reliance on vendor support.

Netherlands Vaccine Institute

Sandra Zwambag

Document Controller