Press Releases

TraceLink Ensures Jan 2015 DSCSA Compliance with Product Track 5.2

September 29, 2014

TraceLink Inc., the leader in protecting patient safety and enabling health for global Life Sciences, announced today the latest version of their Life Sciences Cloud platform and Product Track application for end-to-end Drug Supply Chain Security Act (DSCSA) compliance. With only three months until DSCSA deadlines, TraceLink’s latest release of the industry’s only Transaction History Management System provides all the necessary network connectivity, operational use case and compliance data management tools to ensure January 1, 2015 compliance. A single connection to the Life Sciences Cloud delivers end-to-end DSCSA compliance for all DSCSA requirements of the largest pharmaceutical company or the smallest pharmacy across all supplier and trading partner relationships.

“Quest serves a large pharmaceutical network of over 2,000 independent pharmacies that rely on us to supply them with secure, compliant medicines,” said Debbie Boaz, Director of IT and Regulatory Affairs at Quest Pharmaceuticals. “With 2015 DSCSA deadlines fast approaching, partnering with TraceLink was our only realistic option given the size of our staff and diversity of our network. We work with TraceLink to create one connection from the Life Sciences Cloud to our business operations and let TraceLink worry about connecting our pharmaceutical suppliers and pharmacy trading partners.”

“Since we released the first version of our Transaction History Management System in May, we have gained extensive feedback from customers starting to deploy their compliance programs for January 2015,” said Shabbir Dahod, President and CEO of TraceLink. “TraceLink delivers the only mature, field-tested platform that demonstrably minimizes the cost, risk and time in meeting the impending DSCSA deadlines. With hundreds of companies already configured on the TraceLink Network for DSCSA compliance and thousands more in process, we can quickly get any company on-boarded and connected to their trading partners in weeks, not months.“

TraceLink Product Track for Secure Jan. 1, 2015 DSCSA Compliance

TraceLink Product Track delivers comprehensive end-to-end DSCSA compliance for all members of the supply chain (manufacturer, repackager, wholesale distributor, pharmacy chain, hospital and clinic): (1) full DSCSA Tracing, Verification and Serialization compliance, (2) complete connectivity to all supply and trading partners using flexible HDMA ASN, GS1 EPCIS and web portal options and (3) comprehensive outsourced supply network management that connects all members of a company’s network onto the Life Sciences Cloud to ensure DSCSA compliance for Jan. 1, 2015.

“As a diversified pharmaceutical company, DSCSA poses a particular challenge for Pharmasphere Inc. as we have multiple business units and diverse business operations which create unique DSCSA compliance requirements,” said Joe Pizza, Vice President of Information Technology at Pharmasphere Inc., “Product Track not only helps isolate us from the diverse data exchange requirements of our distribution network, but also gives us the needed operational flexibility to meet DSCSA without reengineering our business processes.”

The latest version of Product Track brings additional operational use cases, enhanced ease of use and improved implementation flexibility for companies of all sizes and network complexities on TraceLink’s fully audited and validated multi-tenant cloud platform. TraceLink’s Transaction History Management System includes key customer-driven, built-in capabilities such as:

  • DSCSA Tracing Data Exchange. Flexible integrated and non-integrated electronic options for exchanging TH/TI/TS with trading partners including HDMA ASN, GS1 EPCIS 1.1 and secure web portal
  • DSCSA Verification Management. 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
  • Flexible TH/TI/TS Configuration. Built-in support for the diverse data management scenarios required in DSCSA including Direct Purchase Statements, flexible lot number handling, custom Transaction Statement text, drop ships and more
  • Network Partner Management. Centralized management of all suppliers/trading partners including verification of partner identity, profile configuration of companies and locations with unique partner identification (DEA, DUNS, DUNS+4, GLN, HIN and more) and configurability of Transaction History delivery on company or location basis
  • DSCSA Product Management. Management of both DSCSA-compliant and DSCSA-exempt products in integrated data transactions between companies
  • Wholesale Distribution Management. Efficient DSCSA compliance management for lot-level product during receiving and putaway, pick-pack-ship operations and internal inventory operations such as quarantine combined with creation of new Transaction History and secure update of existing Transaction History based on exception processing
  • Repackaging Management. Creation of repackager-initiated Transaction Histories and linkage to source product
  • Saleable Returns. Secure, efficient management of Transaction Histories for saleable returns processing
  • Secure Compliance Repository. Elastic, secure, fully indexed data repository for TH/TI/TS documents, Verification records and serialization data that protects compliance information while providing full online access across the entire 6-year DSCSA record retention period
  • DSCSA Grandfathering. Creation of Transaction Histories for product already in the supply chain after Jan. 1, 2015
  • Audit Trail. Extensive audit trailing of events and transactions with internal business systems and network subscribers for corporate governance
  • Master Data Management. Complete product and partner master data management through a standardized integration interface

All of TraceLink’s DSCSA and global track and trace compliance solutions are fully deployed and integrated on the Life Science Cloud, the industry’s only designed-for-cloud platform developed on the Amazon AWS Cloud infrastructure.

To partner with TraceLink to understand the DSCSA regulatory impacts on your business and ensure secure DSCSA compliance for 2015 and beyond, visit www.tracelink.com.

About TraceLink

TraceLink protects patients and enables health for companies across the global Life Sciences supply network through the TraceLink Life Sciences Cloud. The TraceLink Life Sciences Cloud is an Amazon AWS-based cloud application platform which enables complete global connectivity, visibility and traceability of pharmaceuticals from ingredient to patient. A single point and click connection to the Life Sciences Cloud creates a supply chain control tower that 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 trusted by thirteen of the top-20 pharmaceutical companies and 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.



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