White Paper

2017 Serialization & Traceability Trends


Pharmaceutical companies have been working diligently to meet global product traceability mandates, particularly the November 2017 U.S. Drug Supply Chain Security Act (DSCSA) serialization requirements.  KPMG’s 2017 Serialization & Traceability Trends Survey found that 45% of respondents have investment more than $50 million to build the necessary capabilities for compliance.

Organizations will  continue to commit significant resources to meet a variety of compliance deadlines over the next five years, while the industry works to achieve full end-to-end traceability of pharmaceutical products.

A compliance program of this magnitude creates significant implementation challenges and disruptions across various functions within and across organizations. However, it also provides opportunities to seek and achieve value through business process improvements and more effective revenue lifecycle management.

How are pharmaceutical companies working to the November 2017 U.S. Drug Supply Chain Security Act (DSCSA) serialization requirements? KPMG’s survey explores the industry’s current state of readiness to meet the 2017 DSCSA requirements and intentions to leverage associated value-added opportunities.

More than 70 percent of survey respondents agreed that serialization data can potentially transform existing business processes.  The biggest potential for value realization from these efforts include “returns credit calculation,” “diversion monitoring,” and “order fulfillment accuracy.”

Other findings in the survey include:

  • 72 percent of respondents can or plant to capture serial number shipping events.
  • 86 percent have extended capabilities for serialization, commissioning data capture beyond their own enterprise to include internal and external suppliers.
  • 48 percent of participants have completed aggregation projects.
  • Only 29 percent of participants have no future plans to use serialization with existing business practices.

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