TraceLink Supports New HDMA 856 ASN for DSCSA 2015 Compliance
TraceLink Inc., the leader in pharmaceutical serialization, track and trace and supply network towers for global Life Sciences, announced today that the company will fully support the newly released Healthcare Distribution Management Association (HDMA) 856 Advance Ship Notice guidelines to help companies comply with the January 1, 2015 compliance deadlines of the Drug Supply Chain Security Act (DQSA Act II). HDMA ASN support will be an integral part of TraceLink’s Transaction History Management System designed for end-to-end DSCSA compliance across the pharmaceutical supply chain. TraceLink’s Life Sciences Cloud version 5.0, being released in May, will offer HDMA ASN as one of several options for the exchange of DSCSA compliance documentation between supply chain trading partners.
The Drug Supply Chain Security Act implements extensive new tracing, verification and serialization regulations for drug products as they move across each change of ownership from pharmaceutical manufacturer to pharmacy dispenser. As part of complying with these regulations, supply chain stakeholders (manufacturers, repackagers, wholesale distributors, dispensers) must receive or send Transaction History, Transaction Information and Transaction Statement for each change of ownership of a drug product.
The HDMA’s 856 ASN for DSCSA (“HDMA Electronic Data Interchange (EDI) Guidelines for the 856 Advance Ship Notice to Support Implementation of DSCSA”) was developed to help provide a standardized approach for the interoperable data exchange of the required Transaction History / Information / Statement between pharmaceutical trading partners. This publication is a key milestone in the industry’s efforts to work together in creating approaches for meeting DSCSA requirements. Having an enhanced ASN data exchange format option is crucial given that the existing GS1 Drug Pedigree Messaging Standard (DPMS) developed for Florida pedigree compliance does not comply with DSCSA requirements.
TraceLink will fully support the HDMA ASN format on the TraceLink Life Sciences Cloud as a key method for companies to exchange required DSCSA compliance documentation. In addition, TraceLink will enhance existing GS1 EPCIS support to the forthcoming GS1 EPCIS 1.1 standard for the exchange of serialized and non-serialized (lot-level) product information for DSCSA. Finally, to ensure maximum interoperability for companies with diverse supply networks, TraceLink will enable the inbound/outbound translation of the HDMA ASN format with other DSCSA data exchange methods such as GS1 EPCIS. For example, this will enable companies to: (1) receive an HDMA ASN format inbound from suppliers then (2) provide compliance documentation in other formats to downstream trading partners who may not have EDI capabilities or who may prefer a different format.
The Life Sciences Cloud, the only secure, validated cloud solution designed for mission-critical Life Sciences operations, provides a highly connected and agile network linking pharmaceutical companies, CMO/CPOs, 3PLs, wholesale distributors and pharmacies. Through a single link to the TraceLink Life Sciences Cloud, any company regardless of size or technical capabilities gains: (1) full US/global track and trace compliance, (2) complete connectivity to all supply and trading partners in their business network and (3) comprehensive outsourced supply network management.
Leading companies turn to TraceLink, the only company with a decade of dedication to building Life Sciences supply chain solutions, for:
- Flexible US DSCSA compliance with a Transaction History Management System that meets all tracing, verification and serialization regulations for lot-level and serialized product while supporting all interoperable data exchange methods including HDMA ASN, GS1 EPCIS 1.1 and secure web portal.
- End-to-end integrated serialization and reporting compliance for China, Korea, India, Brazil and other global track and trace regulations on a single harmonized platform.
- A supply network control tower that improves outsourced production performance, enhances external supply quality management and increases supplier transparency across global markets.
The HDMA Electronic Data Interchange Guidelines for 856 Advance Ship Notice are available through the HDMA website. The HDMA 856 ASN and GS1 EPCIS 1.1 formats will be two key interoperable data exchange methods to be discussed at the upcoming FDA workshop on DSCSA data exchange.
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, insight and collaboration needed to improve performance and reduce risk across global supply, manufacturing and distribution operations. Winner of numerous industry awards including the Amazon AWS Global Start-Up Challenge Grand Prize and the Edison Award for Innovation in Health Management, the TraceLink Life Sciences Cloud is relied upon by businesses across the globe to meet strategic goals in ensuring global compliance, fighting drug counterfeiting, improving on-time and in-full delivery, protecting product quality and reducing operational cost. For more information on TraceLink and our solutions, visit www.tracelink.com.
TraceLink is funded by FirstMark Capital. FirstMark Capital is an early stage venture capital firm based in New York City. FirstMark’s mission is to partner with exceptional entrepreneurs who are changing the world by solving meaningful problems. FirstMark has built a deeply engaged community among the extraordinary teams in the FirstMark network to spread ideas and opportunities. FirstMark is privileged to work alongside the founders of remarkable businesses like Pinterest, Lumosity, Aereo, TapAd, Shopify, Riot Games, and dozens more. Visit FirstMark in New York City or online at firstmarkcap.com and @FirstMarkCap.