Protect Patients Enable Health

Global Track and Trace

Compliance with US DQSA (Drug Quality and Security Act), China, Brazil, Korea, Argentina and other track and trace regulations will cover over 70% of global medicines by 2017. The serialization, product tracing, product verification and government reporting requirements are complex and the risk high.

For guaranteed global track and trace compliance, secure access to emerging market growth and protection of product integrity from ingredient to patient, you need:

  • Integrated US DQSA compliance capabilities (product tracing, product and transaction verification, product serialization, compliance data archival)
  • Modular, off-the-shelf applications for diverse serialization, product tracking and government reporting regulations)
  • Fully outsourced infrastructure and software management in a validated, elastic, native cloud environment
  • Complete network management services that connect you to all of your global supply/trade partners (on-boarding, integration, support)

Solution Vision

Minimize your RISK, COST and TIME with the TraceLink Life Sciences Cloud to meet diverse and evolving global track and trace compliance requirements:

  • Creation of serial numbers and monitoring of allocations for all product types, packaging configurations and global serialization requirements
  • Management of serial number requests from internal packaging sites and external CMO/CPO partners
  • Creation, management and archival of transaction information, histories and statements for US DQSA
  • Product integrity and identity authentication checking at all points in the supply chain
  • Global, standardized approach to governmental reporting from China to Brazil and Argentina
  • Global patient access to product identity verification through mobile devices

Why It's Important

Watch our educational webinars (on demand) on key regulatory requirements (US, China, etc.) and technical standards (GS1, etc.) to see why a global, comprehensive solution is crucial to ensure that you have the connectivity, data and visibility needed to be and stay in compliance.

TraceLink Solutions

Enable integrated end-to-end flow of serialized product identity, product pedigree and other traceability data:

  • Product Track: Meet all US DQSA regulations for tracing, verification and data archival for both lot-level and serialized drug product with all supply chain partners
  • Serial Number Manager: Generate and centrally manage serial numbers using GS1, China EDMC or custom formats for all internal packaging sites, external supply relationships or customer requirements
  • Serial Number Exchange: Exchange serial number requests and monitor serialization events between packaging lines, locations and serial number management systems in a central, coordinated fashion
  • Government Reporting: Centrally manage government reporting requirements for China, Turkey, Argentina and more on a single platform
  • E-Pedigree for DPMS Standards: Generate and exchange Drug Pedigree Messaging Standard (DPMS) pedigrees for secure compliance with Florida and other state pedigree mandates
  • Serial Number Authentication: Verify serialized product identity, track product movements and share product information throughout the supply network
  • Mobile Patient Communication: Scan drug products to verify identity and access product information via iPhone / Android mobile devices and SMS texts
  • ServiceLink: Publish track and trace services to partners, subscribe to customer services and centrally manage user access and subscriber permissions on a per-partner, per-geography basis

Business Impact

  • Secure global compliance with global serialization, DQSA, governmental reporting and other track and trace regulations
  • Increase competitive differentiation and protect product brand trust in markets
  • Protect revenue streams from counterfeit, theft and diversion leakage
  • Reduce stockouts and returns due to damage from temperature excursions and poor handling

Awards and Recognition

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