Issue link: https://resources.axway.com/i/990503
axway.com 5 US DSCSA Compliance Module Enables pharmaceutical manufacturers to comply with current Drug Supply Chain Security Act (DSCSA) requirements. • Captures aggregations, change-of-ownership and decommissioning events to provide a complete picture of the product lifecycle. • Accelerates CMO integration with embedded integration technology that supports diverse message format transformation and connectivity needs. • Associates and manages product master data, serialized events and distribution channel events. • Provides full visibility of serialized product lifecycle. EU FMD Compliance Module Enables pharmaceutical companies to comply with EU Falsified Medicines Directive (FMD) • Provides an end-to-end solution for unique serialization with randomized numbers at the product pack level, upload serialization data to the European Medicines Verification System (EMVS), and support product verification. • Generate serial numbers that meet EFPIA pack coding requirements. • Manage serialized product pack data, and status changes for prescription drugs targeted for European supply chain. • Update the Batch ID and/or Expiration Date of a previously submitted Pack Data report. • Trigger compliance reporting to EMVS based on customer configured operational processes and event data attributes. • On-demand EMVO Verification to request the verification of serial numbers for a given batch. • Initiates recall of an entire batch across one or multiple market(s). • Subscribes to Alerts sent by the European Hub. Additional Compliance Modules Enables pharmaceutical companies to comply with global serialization requirements Support for additional country specific serialization regulations such as Russia, United Arab Emirates (UAE), Saudi Arabia, and others. Optional compliance modules