EUROPEAN MEDICINES VERIFICATION SYSTEM (EMVS)
The European Parliament and Council released a Directive on Falsified Medicine. It aims at improving patient safety by mandating the Marketing Authorisation Holders and manufacturers to put a system in place that is preventing falsified medicines from entering the legal supply chain, the European Medicines Verification System. The European Medicines Verification System (EMVS) should guarantee medicines authenticity by an end-to-end verification.
In essence, manufacturers will be required to print a Data Matrix code, which incorporates a unique identifier (UI) and apply an anti-tampering device on the outer packaging of all medicines for each individual sales package.
At the point of dispense the medicine will be scanned, checked and verified for authenticity against a national (or supranational) repository. If the UI on the pack matches the information in the repository, the pack is decommissioned and supplied to the patient. Otherwise, if there is a warning related to this pack, then the system will highlight this as an exceptional event and the package will not be supplied to the patient. An investigation needs to determine whether the pack has been falsified or not.
In response to the European Parliament and Council's Directive on Falsified Medicine, Assemblysoft was tasked with working as an extended team in developing a critical component of the European Medicines Verification System (EMVS). Our solution aimed to ensure the authenticity of medicines and safeguard the supply chain against falsified products.
After some initial prototyping and an attempt at using the Windows Workflow Foundation to provide the engine capabilities, a number of requirements could not be met so a bespoke solution would need to be developed.
Additionally an instrumentation solution for auditing and logging across the entire service architecture needed to be developed.
- Technical Requirements: Developing a system capable of scanning, verifying, and authenticating medicines against a national or supranational repository.
- Compliance with Directive: Ensuring the solution met all regulatory requirements outlined in the Directive on Falsified Medicine.
- Complex System Integration: Integrating the solution within the broader European healthcare infrastructure.
The solution made extensive use of Azure Service Bus, Topics and Queues, Worker roles and a bespoke Workflow Engine along with semantic logging.
The Workflow Engine
Assemblysoft worked alongside the internal development team and Microsoft consultants to design and build a bespoke Workflow Engine that would run in Microsoft Azure. Having previous experience developing with the Windows Workflow Foundation, we were able to model and apply some best practices to the new engine.
The engine was dynamic and fluid in nature to cater for the amount of different paths into the system and dynamic decisions that would be required based on the characteristics of each request. It proved a big hit with the developers that worked against the design of the coded workflows with 6 sub teams developing individual complex workflows using the model workflow developed to demonstrate typical use-cases.
- Advanced Technology Use: Utilising Azure Service Bus, Topics, and Queues, along with Worker roles, we created a robust infrastructure for the EMVS.
- Bespoke Workflow Engine: After initial prototyping, it was clear that a custom-built workflow engine was necessary to meet the unique requirements of the EMVS.
- Semantic Logging and Auditing: Developing an instrumentation solution for comprehensive auditing and logging across the entire service architecture, ensuring traceability and compliance.
Once the core workflow engine development was complete, we turned our attention to the auditing and logging. We utilised a Semantic Logging solution based on the enterprise nature that enabled us to provide custom event sources and schematic data to model the different layers in the application.
EMVS Requirements Compliance
Our solution meticulously adhered to the EMVS requirements:
- Data Matrix Code Implementation: Ensuring each medicine package was equipped with a unique identifier (UI) within a Data Matrix code.
- Anti-Tampering Mechanism: Incorporating an anti-tampering device on medicine packaging for additional security.
- Verification and Decommissioning Process: Enabling the scanning and verification of medicines at the point of dispense, with a system to decommission or flag exceptional events.
The bespoke solution delivered significant outcomes:
- Enhanced Medicine Safety: Our system played a crucial role in preventing falsified medicines from entering the legal supply chain.
- Compliance with European Directive: The solution fully complied with the stringent requirements of the European Directive on Falsified Medicine.
- Reliable Medicine Verification: Provided a reliable, end-to-end verification process for medicine authenticity.
The project offered substantial business benefits:
- Strengthened Public Health Safety: By ensuring the authenticity of medicines, the solution directly contributed to public health safety in Europe.
- Technical Leadership: The development of a custom solution demonstrated Assemblysoft's capability to handle complex, high-stakes projects.
- Compliance and Reliability: Our adherence to regulatory standards and robust solution reinforced our reputation for compliance and reliability in the healthcare sector.
- Delivery : We delivered on time
- Flexibility : The workflow engine covered all the use cases
- Performance: Tests conducted with several billion records
- Cross cutting and consistent Logging and Auditing insights across all teams and application services
Assemblysoft's development of a bespoke solution for the European Medicines Verification System showcases our commitment to public health safety and our ability to deliver complex, regulatory-compliant technological solutions. Our innovative approach to the challenges presented by the European Directive on Falsified Medicine not only safeguarded the medicine supply chain but also positioned us as a key player in the healthcare technology sector.
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