The European Medicines Verification System (EMVS) represents the pharmaceutical industry’s response to the European Union’s Falsified Medicines Directive (FMD) protects 520 million European citizens from falsified and counterfeit medicines. The FMD requires a European system to detect, identify, and eliminate falsified medicines. Solidsoft Reply was entrusted with the project to build and operate the EMVS. In February 2019, every pack of prescription medicine entering the European pharmaceutical supply chain must bear a unique identifier to meet regulations. The EMVS must be used to verify every pack identifier at the point of dispense. Every drug manufacturer, parallel distributor, wholesaler, hospital, and pharmacy operating across 32 nation states of the European Union and the European Free Trade Area are obligated to be connected to the EMVS.
Solidsoft Reply chose Service Fabric as the most appropriate platform to build a microservice based solution to meet the demands of the legal requirements. Service Fabric provides the intelligent cluster-based service orchestration, routing, and state management that the EMVS requires. Service Fabric offers high levels of resilience, availability, and scalability. The Solidsoft Reply development team took advantage of the first-class support in Service Fabric for stateful service models to support the asynchronous, persisted interchanges that the EMVS needs to enable scalable, resilient workflows.
The investment made in designing and implementing Service Fabric patterns in the European Hub has directly benefitted the implementation of the National Blueprint Systems (NBS). It customs the same patterns and approaches to handle interchange with the European Hub and to manage other asynchronous processing at the national level. The ability to repurpose architectural and design patterns has significantly accelerated the development of the NBS in the face of demanding timescales.
Service Fabric, with its support for Microservice architecture, complements the agile methodology used to deliver NBS functionality. The Solidsoft Reply development team has been able to support national pilot programs and roll-out before the deadline of February 2019.
Comprehensive and rigorous testing of complex distributed systems is always challenging. Solidsoft Reply built its own automated test framework to support the needs of the EMVS program. The framework provides a comprehensive approach to black-box and grey-box testing of the system as a whole, as well as the individual European and national-level components of the EMVS. The framework provides readily available test metrics via Microsoft Power BI.
The pharmaceutical industry is highly regulated. The EMVS complies with GAMP 5 GxP best practice standards and constitutes a verified system with detailed traceability of functionality back to the formal requirements and functional specification, and an emphasis on robust configuration management of individual releases and environments. Solidsoft Reply operates the European Hub and National Systems on behalf of its customers and implements comprehensive operational management processes used Azure-hosted tooling.
Solidsoft Reply has 25+ years’ experience in developing custom applications using Microsoft technology and was one of the original Microsoft partners to offer cloud solutions using the Microsoft Azure platform. Solidsoft Reply are considered a leader for Microsoft Integration solutions, with a portfolio of over 500+ customer engagements through delivering enterprise integration solutions with Microsoft technology. As the demand for cloud based integration has evolved, Solidsoft Reply has been pioneering the use of Logic Apps, API Management and Service Bus using the Azure platform as well as utilising BizTalk’s cloud capability to create hybrid solutions. Solidsoft Reply’s continued commitment to offering cutting edge solutions using Microsoft technologies has been recognised by the achievement of numerous awards, most recently attaining the Microsoft Global Health Partner of the Year award in 2018.