As a result of the reform, Fimea now has an up-to-date and easy-to-use register containing correct information on all medicines that have marketing authorisations in Finland. Solita also created a modern registry platform for Fimea, which makes the creation of new registers much easier and faster.
Trust enabled agility in a demanding industry
“The reforms have enabled us to implement new systems in an agile way. The cooperation with Solita has been exceptionally smooth. The team has worked really seamlessly together, and the industry expertise of Solita’s employees has been impressive. Trust between operators has grown continuously, which has enabled agile practices in a demanding industry,” says Joonas Tuominen, Fimea’s IT Development Manager.
Old register required changes and modernisation
Fimea wanted a more modern, efficient and user-friendly register of medicinal products and marketing authorisations. The existing register had been introduced in the 1990s and had some clear shortcomings that needed to be addressed, and the register needed modernisation to meet the current requirements.
“The appearance and usability, as well as the volume of data we are able to enter, changed in a flash with the new Saga register. We made a huge leap from the old system to the new one,” says Sofia Lahtonen, Fimea’s System Coordinator.
The cooperation between Solita and Fimea started in late spring 2019, and the first part of the register was taken into use in autumn 2020. Saga is a demanding package that requires strong industry expertise, including knowledge of legislation. Solita has invested heavily in industry expertise and knowledge of regulations to ensure a strong contribution to the design work.
“We need a deep understanding of the health and wellbeing industry to be able figure out together with our customers how systems should be developed. In addition to domain expertise, we need user experience expertise, for example. In a large entity like Saga, we also need a good understanding of how the different changes will affect not only the features of the register, but also integration with other systems. Success has required seamless cooperation between us and Fimea – we have worked as a team, of which I am extremely pleased,” says Jukka Sillanpää, Solita’s Project Manager.
Modern platform to facilitate and standardise creation of new registers
The goal with the Saga project was to create a single place where applications are submitted and decisions are received. Saga was to become an efficient register with consistent data models and processes that would guide users more clearly in all the different views. The register was to contain correct information about all medicinal products with marketing authorisations in Finland.
“Our goal was to have an easy-to-use, modern register that would give us access to a wide range of data and would integrate more easily with other systems,” says Heidi Mustalammi, Fimea’s Procedure Manager who is in charge of veterinary medicines.
In addition to the Saga reform, Fimea and Solita wanted to build a shared platform that would speed up and facilitate future register projects. The aim was to build and develop all of Fimea’s registers using the same operating logic and line of reasoning.
“The idea was that we would not always have to start from scratch. We wanted to build a technical environment with specific integrated services. This way, these features can be made available to new registers with minimum effort,” says Sillanpää from Solita.