Description

TraceLink’s Saudi Arabia Compliance application provides capabilities to support marketing authorization holders / manufacturers and other companies in meeting the requirements of Saudi Arabia for serializing and reporting upon pharmaceutical products and their traceability transactions to the Saudi Arabia RSD drug track and trace system. 

Benefits

• Supports a wide range of business and operational use cases for marketing authorization holders and pharmaceutical manufacturers producing product for and distributing product within the Saudi Arabia market
• Supports companies with wholesale distribution use cases for the management of shipments, receipts and other distribution operations
• Provides a common global platform for compliance reporting and compliance data management when used as part of TraceLink’s global track and trace compliance network  
• Delivers flexibility in leveraging TraceLink serialization applications for Saudi Arabia serialization management and triggering of reporting actions, or the use of existing third-party solutions which may be in place
• Leverages the extensive network of pre-existing integrations with CMOs and 3PLs to speed access to key compliance information

Capabilities and Features

Saudi Arabia Compliance provides the intelligent compliance data management and reporting system needed for the complex master data and traceability transaction reporting requirements documented in Saudi Arabia traceability regulations

• Delivers flexible workflows, business rules, and data configuration capabilities needed for complex operational and supply chain requirements
• Configure and generate Saudi Arabia compliance reports for Supply, Import, Dispatch, Accept, Deactivate, and other transaction reports defined in the regulations for product commissioning, shipment / receipt, warehouse operations, and other operational use cases
• Enables submission and exchange of product and aggregation data to the Package Transfer System (PTS) via PTS Upload and PTS Download transactions in EPCIS and CSV formats to support provision of aggregation information to trade partners
• Enables automated report generation/submission triggered from operational events or manual report submission to the RSD system

• Provides a rich UI for search, viewing, and analysis of submitted reports
• Provides audit trailing of events, submitted reports and system responses