Fully Compliant Serialization

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The safety of the drug supply is the number one focus for the pharmaceutical and life sciences industry.  Counterfeit, stolen or misdirected products can endanger the health and safety of patients. With this problem dramatically increasing worldwide in recent years, the Drug Supply Chain Safety Act (DSCSA) was signed into law in 2013.  To comply with federal mandates, manufacturers, distributors and retailers must be able to track, trace and report on the movement of prescription drugs and medical devices, throughout the supply chain.  

STEPLogic Trace is a comprehensive solution that supports cradle to grave tracking within the distribution center. Trace was designed to manage the aggregation of serial numbers in a parent child relationship, creating efficiencies in managing the data without compromising quality.  The system has been audited and validated for FDA Part 11 compliancy as well. Additionally, Trace enables companies to record serialized drugs, aggregate them by unit of measure, and then connect multiple systems, platforms and trading partners to view the supply chain in its entirety. Trace allows for the serialization of every type of transaction or can be configured to manage capture of serial numbers just on inbound and outbound transactions.  

 

Watch the Johnson & Johnson, Securing the Drug Supply Chain Webinar

With the unique capabilities of the STEPLogic platform, users can create apps, write scripts and run reports that enable companies to match the dynamically changing requirements of the DSCSA and other country mandates. Because of the adaptability of the STEPLogic platform, Trace and can easily integrate with any WMS and applied to the operation in a manner that makes the most sense for you.  Trace is integrated with industry leading repository systems like SAP ATTp and Tracelink, as well as with conveyor scanning and sorting systems

DSCSA Serialization system that provides end to end track and trace of pharmaceuticals

  • Fully compliant with federal serialization requirements
  • Easily integrates with repository systems (SAP ATTp, TraceLink)
  • Serial number aggregation to four or more levels
  • Easy to personalize and configure to meet individual operations
  • Customize processes and reporting structure, using the innovative STEPLogic platform

 

 

 Download our Serialization White Paper here.