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5
Optional compliance modules
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
