TraceLink Launches DSCSA Transaction History Management Solution
TraceLink Inc., the leader in pharmaceutical serialization, track and trace and supply network towers for global Life Sciences, announced today the release of TraceLink Life Sciences Cloud version 5.0 with Product Track, the industry’s first Transaction History Management System for end-to-end Drug Supply Chain Security Act (DSCSA) compliance starting on January 1, 2015. Product Track delivers a complete DSCSA Tracing, Verification and Serialization solution for the unique requirements of all companies across the pharmaceutical supply chain, including flexible HDMA ASN, GS1
“Our customers trust TraceLink to be their partner in understanding and meeting new regulatory compliance requirements like DSCSA regardless of the size of their business or the complexity of their trade network,” said Shabbir Dahod, President and CEO of TraceLink. “In response, we developed a true Transaction History Management System to help our customers deal with DSCSA regulatory complexity, pharmaceutical trading partner diversity and the need for operational efficiency in a secure compliance environment. TraceLink helps take the risk and complexity of DSCSA compliance off our customers’ shoulders, enabling them to focus on serving patients not managing systems.”
DSCSA, Title II of the Drug Quality and Security Act, implements new regulations governing drug products across all changes of ownership from pharmaceutical manufacturer to pharmacy dispenser. DSCSA regulations require:
- Tracing: Provide, receive and manage Transaction History (TH), Transaction Information (TI) and Transaction Statement (TS) compliance documents for each change of ownership of a drug product
- Verification: Retrieve, analyze, verify and provide TH, TI, TS for each product in response to queries from government officials during suspect product investigations and drug recalls
- Serialization: Serialize drug products at the saleable unit and case level for manufactured and repackaged product
The Life Sciences Cloud, the only secure, validated cloud solution designed for Life Sciences operations, provides a highly connected network linking pharmaceutical companies, CMO/CPOs, 3PLs, wholesale distributors and pharmacies that is tailor-made for fast, secure DSCSA compliance. A single connection to the TraceLink Life Sciences Cloud delivers: (1) full DSCSA Tracing, Verification and Serialization compliance, (2) complete connectivity to all supply and trading partners and (3) comprehensive outsourced supply network management for any company regardless of size or technical capability.
TraceLink Product Track for DSCSA Compliance
Informed by close collaboration with dozens of leading companies in the pharmaceutical supply chain, TraceLink leveraged over a decade of experience delivering life science compliance solutions to create Product Track, TraceLink’s Transaction History Management System on the Life Sciences Cloud. Key benefits for all companies include:
- Standardized DSCSA data exchange with trading partners in a variety of integrated formats including HDMA ASN and GS1 EPCIS 1.1
- Secure web portal with extensive DSCSA compliance capabilities to support electronic sharing of TH/TI/TS with dispensers and other trading partners lacking full integration capabilities
- TH/TI/TS configuration flexibility to meet diverse DSCSA data management requirements including Direct Purchase Statements, flexible lot number handling and more
- Flexible verification query interface that enables quick analysis and response by compliance, quality and product integrity teams to Request for Information and Verification queries from the FDA and government officials
- Extensive operational use case support for shipping, receiving, repackaging, drop shipments and returns with full exception management
- Flexible operational triggers and product-Transaction History mapping enable efficient lot-level receiving, inventory management and pick-pack-ship support for distribution operations
- Integrated lot-level and serialized product capabilities to facilitate 2015 compliance and ongoing serialization pilots for future DSCSA compliance deadlines
- Elastic, secure TH/TI/TS data repository that protects compliance documents while providing full online access to compliance records across the entire 6-year DSCSA record retention period for verification requirements
TraceLink’s DSCSA compliance solutions join TraceLink’s global track and trace applications for China, Turkey, Brazil and other countries that are trusted by eight of the top 12 pharmaceutical companies and connect over 47,000 trading partners and endpoints on the global supply network.
Learn more about TraceLink’s pharmaceutical track and trace solutions and supply network tower applications at www.tracelink.com.
TraceLink protects patients, enables health, grows profits and ensures compliance for companies across the global Life Sciences network through the TraceLink Life Sciences Cloud. The TraceLink Life Sciences Cloud is an Amazon AWS-based cloud application platform enabling complete global connectivity, visibility and traceability of pharmaceuticals from ingredient to patient. A single point and click connection to the Life Sciences Cloud delivers the information,
TraceLink is funded by FirstMark Capital. FirstMark Capital is an