Under Federal Law No. 425-FZ, which was signed and published in December 2017, companies are required to manage serialization and traceability of medicines from manufacturer to patient, and report product and transaction events to the central government system. Requiring the tracking of all product movement, both physical and economic zone movement, makes Russia’s reporting requirements some of the most complex in the industry.
Because of these complexities, solution capabilities require more than simply creating a report in a desired format, but managing the choreography of transactions based on various supply chain processes and previous transaction results. Compliance requires that a company’s entire supply chain for Russia medicines be modeled and instrumented to detect specific supply chain events.
TraceLink’s network-tenant model has the architecture and configurable workflows to support the modeling and monitoring of your Russia supply chain and provides the operational scale needed to track and report the movement of products in compliance with the Russia regulations.
TraceLink’s Russia Compliance offering is an integrated solution that consists of three major components: core serialization alongside Russia compliance, reporting capabilities, and crypto code management.
The core serialization module of TraceLink’s solution covers product master data management, serial number management, line system operations and warehouse operations. The Russia compliance and reporting application manages regulatory document creation, electronic document signature, and document archive. Additionally, the compliance application enables companies to digitally sign, send, and receive documents from Russia’s regulatory authority from services located in Russia in accordance with the law.
The solution is also designed to automatically generate compliance reports that support four main uses cases, including:
Production outside of Russia, importation, and transfer to a distribution warehouse
Production in Russia and transfer to a distribution warehouse
Warehouse operations and distribution
TraceLink also offers a Russia Crypto Code application which allows you to manage the lifecycle of cryptographic codes. This provides a single integration point to the Order Management Station (OMS) for all customers and their CMO sites that package Russian products.
Russia compliance requires a partner with deep knowledge of the industry and a clear understanding of the law’s unique serialization and reporting mandates. TraceLink has a proven record of delivering serialization solutions across the globe via our world-leading, cloud-based platform and integrated digital supply network.
A complete suite of proven applications allows companies to create and exchange serial numbers as well as manage serialized operations: Serial Number Manager, Serial Number Exchange, and Serialized Operations Manager.
Russia Compliance enables you to report on serialized events, and manage import, export, receipt, transfer, and shipment processes. It handles the extensive data requirements for each event, including several Russia-specific elements like pricing. Russia Compliance reporting also produces reports in .xml format and encodes them with electronic signatures, employing a new level of technical sophistication not seen in other markets.
Russia Crypto Code
TraceLink’s Russia Crypto Code application manages the lifecycle of cryptographic codes and provides a single integration point to the CRPT for all customers and their CMO sites that package Russian products. Russia Crypto Code is a standalone application but maintains integrations with TraceLink’s Product Serialization solution applications: Master Data Exchange, Serial Number Manager, Serial Number Exchange and Serialized Operations Manager. The application integrates into your current systems to manage crypto codes across Level 3 systems and multiple sites.
Smart Inventory Tracker provides serialization and aggregation management for warehouses and distribution centers, including serialized shipping and receiving and exception management as well as integration with Serialized Operations Manager to trigger associated warehouse events.
Automated execution of test scripts and documentation to support continual software compliance aligned with GxP standards, including validation materials for Russia solution components, Smart Inventory Tracker and Product Serialization. Automated Validation Manager addresses the requirements of the Performance Qualification (PQ). With Installation Qualification (IQ) and Operational Qualification (OQ) support also included in the SaaS license, TraceLink reduces the cost and time associated with validating your compliance solution.
Give your team the training and skills to support your compliance and business requirements. Enhance the value of your TraceLink solutions with instructor-led courses, self-paced learning, and hands-on experiences that go beyond core product training. Select the support that aligns to the needs of each team member—from individual contributors and department managers to administrators.