U.S. Drug Supply Chain Security Act (DSCSA)

TraceLink aids manufacturers in meeting DSCSA 2023 compliance through a comprehensive solution that simplifies and secures the exchange of traceability data. Through a single connection to the TraceLink platform, TraceLink enables manufacturers to integrate with any trade partner and efficiently manage and exchange serialized Transaction Information (TI) and Transaction Statements (TS). This approach not only ensures compliance but also enhances operational efficiency and supply chain security.

• Facilitates seamless exchange of EPCIS transactions with over 290,000 network members via a single integration.
• Provides scalable cloud architecture to handle increased data and transactions without disrupting operational processes.
• Simplifies DSCSA 2023 compliance by offering updates and new capabilities without disrupting existing integrations.
• Reduces supply risk by using predictive analytics to prevent drug shortages and simplify recall processes.

TraceLink empowers wholesale distributors to efficiently manage DSCSA 2023 compliance by facilitating secure, simplified exchange of serialized transaction information (TI) and transaction statements (TS) across a vast pharmaceutical supply network. Leveraging a single digital connection, distributors can streamline operations, improve traceability, and ensure seamless collaboration with suppliers and customers. This unified approach enhances operational efficiency, ensuring compliance without the need for extensive system modifications or multiple integrations.

• Enables one-time integration for exchanging EPCIS transactions with all partners, ensuring item-level traceability and operational efficiency.
• Simplifies warehouse operations and product verification processes, enhancing the ability to handle serialized and aggregated products.
• Provides comprehensive solutions for product tracking, master data sharing, and verification to support saleable returns and suspect product investigations.
• Creates a digital twin of physical product flow  to manage serialized products and minimize supply risk.

TraceLink DSCSA Compliance for Dispensers ensures DSCSA 2023 compliance through secure and efficient data exchange with suppliers, simplifying the process of sending and receiving serialized Transaction Information and Transaction Statements. By leveraging the TraceLink Digital Network Platform, retail pharmacies and health systems can integrate with any trading partner, streamlining operations while ensuring product verification and compliance with FDA mandates. This approach not only aids in achieving regulatory compliance but also enhances operational efficiency and supply chain visibility.

• Provides a single integration point for dispensers to connect with all suppliers, ensuring comprehensive item-level traceability.
• Simplifies the process of receiving, validating, and storing electronic transaction information and statements, making data retrieval efficient during audits or inspections.
• Enhances product verification capabilities, ensuring dispensers can accurately verify serialized product identifiers for safety and compliance.