Name: South Korea Pharmaceuticals
Brand: TraceLink

Products

Advanced data management and reporting solutions to meet traceability compliance requirements in South Korea

blue

Product overview

Comply with South Korea serialization and reporting requirements

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

With South Korea Pharmaceuticals, you can:

Confidently meet South Korea traceability requirements

Streamline regional compliance operations and processes

Insulate internal enterprise systems from regional compliance demands

Industry challenges

New compliance requirements demand new compliance solutions

Today’s marketing authorization holders and pharmaceutical manufacturers face immense challenges managing regulatory compliance and navigating evolving requirements in South Korea. These challenges include:

Management of master data for reporting

In South Korea, reporting is required across a broad range of pharmaceutical products, including normal pharmaceuticals and special classes of pharmaceutical products, each with special handling requirements and unexpected data submission fields such as unit price.

Management of master data for reporting

Separate product/shipment and serialization data templates

Separate product/shipment and serialization data templates create challenges in ensuring correct linkage, submission, archival, and retrieval for pharmaceutical companies.

Separate product/shipment and serialization data templates

Disjointed communication during reporting

Extensive error checking during report submission and asynchronous response messages create complexities for both report management and operational processes.

Disjointed communication during reporting

Product benefits

Manage compliance reporting for all products

Support compliance reporting across a broad range of pharmaceutical products, including normal ethical pharmaceuticals, special classes of pharmaceutical products, each with special handling requirements.

Product benefits

Manage extensive data capture 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.

Product benefits

Automate information preparation

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.

Product benefits

Utilize manufacturer/MAH and distribution operational support

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 number, PO number, or invoice number.

Product benefits

Streamline error checking

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

TraceLink South Korea Pharmaceuticals

South Korea Pharmaceuticals provides the advanced compliance data management and reporting capabilities critical in keeping your business in compliance with South Korea regulations, while maintaining operational efficiency across production and distribution operations.

Manage workflows & data

Customize reports

Submit reports

Utilize 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, including:
Sales shipment
Return receipt
Discard or destruction
Correction
Cancellation

Configure reports for the diverse set of South Korea shipment types and reporting frequencies for wholesale distributor, healthcare provider, military, export, sample, donation, and more.

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.

Provide search and analysis of submitted reports, and track exceptions, with audit trailing of submitted reports and system responses.

South Korea Pharmaceuticals