Description
TraceLink’s Product Track application delivers a flexible and rich compliance data management system for the secure creation, management, and exchange of track and trace data with supply chain partners to meet requirements for compliance with U.S. Drug Supply Chain Security Act (DSCSA) regulations across the U.S. pharmaceutical supply chain.
Benefits
TraceLink’s Product Track application, informed by almost a decade of work with hundreds of companies across the supply chain, provides compliance data management and product traceability capabilities to meet the wide-ranging needs pharmaceutical companies, repackagers, wholesale distributors, pharmacies, and hospitals/healthcare organizations
- Manage complex product distribution ecosystems, high-volume/high-transaction supply networks, and complex product configurations and portfolios through a single, flexible DSCSA compliance application with extensive business rule and data management configurability
- Empower users and sites with powerful, easy-to-use UI tools for compliance management, transaction analysis, and reporting
- Simplify connection to supply and trade partners for exchange of DSCSA Transaction History (TH), Transaction Information (TI), and Transaction Statement (TS) documentation by leveraging platform data integrations and integrate-once, interoperate-with-everyone data translation capabilities with the almost 300K entities connected on the TraceLink Network
- Keep product inventory flowing through warehouse and distribution operations while ensuring compliance with DSCSA requirements with extensive workflow, operational process configuration, and information analysis tools
- Leverage extensive segment-specific business rules, data management capabilities, etc. to tailor Product Track operations for the unique needs of manufacturers, distributors, repackagers, and pharmacy dispensers
- Quickly identify and resolve compliance-related operational exceptions and trade partner data exchange issues
- Develop and maintain a deep information repository of product and transactional information to meet compliance record retention requirements and to inform business decisions and operational excellence activities
Capabilities and Features
Product Track provides an extensive array of compliance data management, operational process support, and supply chain data exchange capabilities to support the diverse, high-volume, and continually evolving business, operational, and technical requirements of companies in the U.S. pharmaceutical supply chain. Key capabilities include:
- Business rules and data management capabilities designed to cover the broad range of TH, TI, and TS configuration and exchange scenarios defined by DSCSA regulations
- Direct purchase, Secondary distribution, Drop shipment, Exclusive distributor, Loan / borrow, Repackaging, Returns, Co-license / affiliate, etc.
- Generation of specific TH, TI, and TS DSCSA compliance data required and optional using DSCSA-based business rules analyzing the current state of the product, the history of that product in the supply chain, the DSCSA requirements of the specific entity in the supply chain, and the operation being undertaken by that entity
- Managing secure exchange of configured DSCSA traceability data between all supply chain partners leveraging platform and network services
- Providing a single integration point to trade partners
- Delivering compliance data to trade partners in their preferred formats (856 ASN for DSCSA, Custom ASN, secure web portal, EPCIS)
- Support for integration with supply chain processes across a diverse set of business and operational use cases
- Manage initial transactions for products being introduced into the supply chain or for repackaged products
- Manage receipts and shipments between manufacturers, direct and indirect purchase wholesale distributors, pharmacy dispensers and other entities
- Manage transactions of serialized and lot-level product shipments
- Manage returns
- Manage drop shipments and other special supply chain transactions
- Manage exceptions (void transactions, update product status and quantity, resend TH, etc.)
- Providing a full featured secure web portal for those companies without the capabilities for full data integration with trading partners
- Providing a flexible interface to search for and analyze compliance data to speed across a wide range of attributes including transactions (shipments, receipts), product code, lot number, PO number, transfer from/transfer to parties, transaction dates and more
- Reconciling Transaction History inventory against physical inventory to analyze transactions and product level data
- Communicate product receipts against Transaction Histories in a shipment
- Take corrective actions to resolve errors (quantities in a shipment, etc.) in DSCSA compliance documents while maintain full audit trail of changes
- Create electronic, fielded Transaction Histories from paper DSCSA documents, including attachment of scanned paper documentation
- Map between different DSCSA TH data formants for inbound and outbound operations w/ trading partners
- Create receipt messages for shipments, returns, etc.
- Managing compliance data for the full DSCSA record retention period
- Providing views and export of compliance reports with information about products, transactions and ownership
- Facilitating responses to DSCSA Requests for Information initiated by the FDA
- Facilitating the creation of an electronic TH from paper compliance documentation
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