Description

TraceLink’s Russia Compliance application enables a pharmaceutical manufacturer or MAH to manage compliance data management and reporting requirements of Russia Federal Law 425-FZ including the reporting of events for domestic and foreign manufacture of pharmaceuticals and their related distribution.

Benefits

Considered the most challenging and complex of today’s pharmaceutical serialization and end-to-end track and trace compliance regulations, 425-FZ requires management of an extensive set of product / transaction data and the orchestration of a wide variety of production and distribution operations to ensure compliance with the extensive and detailed set of reporting requirements for Russian regulations. To support companies in securely meeting these requirements across dozens of compliance reports while minimizing the impact to production and distribution operations, TraceLink’s Russia Compliance application:

• Provides the configuration flexibility and extensive reporting capabilities to help companies model their supply ecosystems and ensure that the right product and transaction reports are configured and submitted when and where required from product packaging to sale in the supply chain
• Reduces Russia compliance risk for companies by enabling them to leverage built-in business rules designed to meet the complex data and event choreography defined in the Russian regulations
• Delivers an reporting solution that can be tightly integrated to internal serialization / packaging, distribution, and other systems to automate Russian compliance as part of normal day-to-day business operations, or loosely connected and driven via a rich manual user interface to support evolving business and user needs
• Provides the operational scale and performance needed to track and report the movement of high-volume/high-velocity products through internal distribution networks and external supply chain channels while meeting complex compliance transaction reporting requirements

Capabilities and Features

Russia Compliance helps create a comprehensive and flexible compliance platform for meeting Russia’s complex compliance data management and reporting requirements.

• Configure and generate Russia compliance reports to support a wide variety of operational use cases and  event choreographies for your complex supply ecosystem
  • Production outside of Russia
  • Importation and transfer
  • Domestic production
  • Warehouse operations, distribution and 3PL activities
  • Customs clearance
  • Reverse logistics and exception processing (destruction, etc.)
  • Product configuration changes (repackaging, aggregation, etc.)
  • Special scenarios (own funds product receipt, control samples, etc.)
• Leverage extensive business rules to ensure that complex Russia compliance reports have correctly configured product / company master data and transaction information based on specific report requirements
• Trigger compliance report generation and submission using out-of-the-box automated workflows from standard TraceLink Serialized Operations Manager events or from third party serialization and distribution systems
• Leverage manual report generation and submission capabilities to provide flexibility for unexpected situations, to meet unique facility requirements, or to manage exceptions
• Digitally sign and transmit complaint XML messages to the Russia MDLP system to comply with Russia regulatory requirements
• Capture system response messages from the Russia MDLP system to help verify correct submission/processing or to enable quick action on negative responses or issues
• Receive inbound messages from the Russia MDLP system for product movements or transactions triggered by supply or trade partners
• Search, view, and examine both current and historical reports
• Automatically capture critical events and transactions in the audit trail
• Leverage TraceLink Russia Compliance as part of a complete, harmonized compliance approach using TraceLink serialization solutions, or use Russia Compliance to meet regulatory requirements as an add-on to third-party serialization applications