Gartner Report

Gartner

Assessment of Track-and-Trace and Serialization Legislation for Life Science Companies, United States, April 2016

U.S. Legislation (DSCSA) for securing drugs across U.S. supply chains continues to develop. Supply chain leaders and their trading partners responsible for serialization compliance must balance immediate reporting mandates with longer-term serialization deployment strategies.

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  • New DSCSA developments proposed from the FDA 2017 compliance requirement.
  • Elevated FDA communications through multiple initiatives for further piloting, analysis and adjusted reporting to facilitate cadence and integration across manufacturers, repackagers, wholesale distributors and dispensers.
  • Variable levels of maturity for meeting DSCSA requirements among contract manufacturers and repackagers.

Ensure 2017 compliance-based requirements planning are well underway and are your top priority. Review your internal skills and resource allocation for managing serialization projects at the IT operations, operational line and DSCSA expertise level. Optimize the value of collaboration now across impacted supply chain stakeholders. Drive serialization readiness for your organization and set expectations for your impacted supply chain stakeholders moving forward.

Use the timetables, charts and recommendations in this research to track and enable continued tactical and strategic decision making for phased serialization deployments within the U.S. and globally.

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