Preparing for global track and trace regulations is a strategic requirement.
In the fight to protect patient safety and ensure product integrity, countries around the world have accelerated their adoption of track and trace mandates: more than 75% of the global medicine supply will be impacted by early 2019. These regulations complicate your supply planning and network IT architecture, and have a ripple effect throughout your business.
Track and trace begins with serialization but generally has additional components. Every country that currently has a law in play has at least one other requirement, including:
- Product Tracing or Tracking: Following the movement of product along the different hops of the supply chain.
- Verification: The process by which product must be verified at one or more stops along the supply chain, comparing its serial number to other key data to ensure its legitimacy.
- Reporting: Once a drug or serial number reaches certain milestones or events, many countries require that data be reported to at least the responsible government agency and, in some cases, to other supply chain partners. Often there are data retention requirements for all events for up to 12 years.
Ensure readiness for both government and trade partner track and trace requirements.
TraceLink's comprehensive global track and trace platform minimizes your risk, cost and time in meeting today's diverse and evolving global track and trace compliance requirements - with a single connection.
- Create serial numbers and monitoring of allocations for all product types, packaging configurations and global requirements
- Manage serial number requests from internal packaging sites and external CMO/CPO partners
- Create, manage and archive transaction history, information, and statements for US Drug Supply Chain Security Act (DSCSA) regulations
- Enable end-to-end supply chain tracking of drug products and their movements
- Establish a global, standardized approach to government reporting from China, to South Korea, Argentina, Turkey and beyond
- Enable verification of product identity and transaction histories from all points in the supply chain for the US, EU and more
Support global patient access to product identity verification through mobile devices