The serialization and reporting requirements for Russia are considered by many to be the most complex requirements in the world. By 2020, all medicines imported into and traded within Russia must comply with the regulation. Depending on the business, operating, and distribution models, a company may be responsible for tracking and reporting on over 35 distinct serialization events. Complicating the requirements even more is the requirement that each transaction sent to the Russia FSIS MDC solution must be digitally signed.
TraceLink’s Russia Compliance application is built on the same network tenant platform providing it with the core serialization, integration, and compliance functionality available in our other applications. Our configurable workflows and application logic are designed to meet the complex data choreography requirements needed to meet Russia compliance.
With Russia Compliance, you can:
- Report on commission, decommission, and aggregation serialized events
- Support quality sampling and quality control release processes
- Manage the import, export, receipt, transfer, and shipment processes
- Track and manage market withdrawal and recall processes for compliance reporting
- Digitally sign XML messages that will be sent to the government system
- Sequence messages, process acknowledgements, and archive sent and received messages in compliance with regulatory
- Maintain an audit trail of actions from sending and receiving messages