Maija Gohlke, FiMVO General Manager
In the end of 2023, the Finnish Medicines Verification Organisation FiMVO changed the supplier of the medicines verification system (FiMVS). The supplier changed from Arvato to Solidsoft Reply's (SSR). This change was the first of its kind within the EMVS (European Medicines Verification System) ecosystem.
It marked a pivotal moment in FiMVO’s mission to ensure the integrity and safety of the pharmaceutical supply chain in Finland.
FiMVO’s decision to switch from Arvato to SSR was driven by several factors aimed at enhancing FiMVO’s operational efficiency, reliability, and futureproofing of the Finnish verification system. Arvato had been the incumbent service provider since the system's implementation, playing a crucial role in the initial setup and operational phase. The decision to change provider was made based on meticulous comparison between the two suppliers and leaning on an in-depth risk assessment.
The transition from Arvato to SSR was carefully planned by the FiMVO team to ensure minimal disruption to the NMVS operations and system End Users. FiMVO worked closely with both service providers to develop a detailed migration plan, encompassing data transfer, system integration, and extensive testing phases.
Key Steps in the Transition
1. Data Migration: One of the critical components of the transition was the secure migration of existing data from Arvato's system to SSR's platform. This process involved rigorous data integrity checks and validation to ensure that all records were accurately transferred without any loss or corruption.
2. System Integration and Testing: Comprehensive testing was conducted to verify the functionality, performance, and security of the new system. The FiMVO team together with SSR ensured that the system could handle the expected workload seamlessly.
3. Stakeholder Training and Support: To facilitate a smooth transition, extensive training sessions were organised for End Users and their IT suppliers. These sessions covered e.g. the new features and functionalities of SSR's system and new practices to maintain End User organisation details. FiMVO and SSR had enhanced support available to address any queries or issues during the transition period.
For pharma companies, the change did not bring any new processes. The upload of the unique identifiers take place through the EU central database, the Hub as before. There were also no additional costs for pharmaceutical companies from the supplier change.
For the FiMVO team, the change process meant a year of extra hard work. Without such a dedicated team, the change would not have been possible. The expertise of everyone on the team was needed. FiMVO also had an additional project coordination resource to help the workload of other team members. In particular, the Tech resource and QA resource were responsible for driving the project forward. In addition to the obvious technical changes, the supplier change required a comprehensive change in the FIMVO quality management system.
In November 2023, the system change was executed successfully without any unplanned downtime. The SSR system was up and running in less time than planned and first transactions took place minutes after the new system was in use. The smooth change would not have been possible without all parties – both suppliers, End Users and their IT-providers, and particularly the FIMVO team -being so committed to make the project a success.
There are currently two medicines verification system suppliers operating in Europe. FiMVO's supplier change was the first, and its success has been closely monitored in the verification community in Europe. The successful transfer is an indication that the system is not tied to a specific operator and a vendor lock can be broken. Having more competition on the market should be a goal for the pharma supply chain to ensure competitive pricing and even more ambitious development of systems.
The medicines verification system needs to stay on top of development, because unfortunately pharma counterfeiters do the same.
The vendor change has been a huge effort for the small FiMVO team. We’d like to thank everyone involved – Solidsoft Reply, Arvato and the Finnish Supply chain for making the change such a great success.
