Description

TraceLink’s South Korea Compliance application provides comprehensive, end-to-end support for pharmaceutical companies looking to meet South Korea’s serialization and compliance reporting regulations.

Benefits

South Korea Compliance supports your business by helping you meet the wide range of business and operational challenges posed by these regulations for medicines produced for the South Korean market including:

• Support compliance reporting across a broad range of pharmaceutical products, including normal ethical pharmaceuticals, special classes of pharmaceutical and OTC products, each with special handling requirements
• Manage the extensive data capture and master data management required for report preparation and submissions, including unexpected fields such as unit price, contract type, and supply class
• Automate preparation of separate product/shipment and serialization data templates to reduce the challenge in ensuring correct linkage, submission, archival and retrieval for pharmaceutical companies while adding complexity for those companies performing wholesale distribution
• Support both pharmaceutical manufacturer / MAH and wholesale distribution use cases, including ability to manage unique distribution issues such as management of submitted reports by the pharmaceutical company supplier that do not contain any transaction identifiers such as delivery #, PO # or invoice #
• Management of the extensive error checking performed by the KPIS system during report submission and asynchronous response messages creates complexities for both report management and operational processes

Capabilities and Features

South Korea Compliance provides the intelligent compliance data management and reporting system needed to help keep your business in compliance with South Korea regulations while maintaining operational efficiency across production and distribution operations.

• Delivers flexible workflows, business rules, and data configuration capabilities needed for complex operational and supply chain requirements
• Capture and format required product master data, serialization/packaging information, and transaction information to generate compliance reports according to specific South Korean template structures for sales shipment, return receipt, discard / destruction, correction, and cancellation events
• Configure reports for the diverse set of shipment types identified under South Korea regulations (wholesale distributor, healthcare provider, military and other special institutions, export, sample, donation, and more) and the varying frequency of reporting depending on the operational event and product type
• Perform outbound file pre-verification against the KPIS system, to pre-check generated reports and validate data fields prior to submission
• Submit generated compliance reports through an integrated fashion with the ESB Adapter to the KPIS system
• Receive and manage responses from the KPIS system for submitted reports
• Provide search and analysis of submitted reports, with audit trailing of submitted reports and system responses
• Generate alerts and track exceptions