Next level of serialization benefits

PAS-X Track&Trace

PAS-X Track & Trace Serialization Aggregation

Benefit from Werum’s PAS-X Track & Trace Serialization software product to comply with the anti-counterfeiting requirements of any country around the globe.

Drug manufacturers can benefit from additional advantages of comprehensive production control and documentation, including equipment management, when integrating the serialization solution into Werum’s packaging solution or MES. 

  • Available as standalone T&T solution
  • Or seamlessly integrated into the packaging solution with EBR or the MES
  • Easy extension with KPI functionality
  • Proven GMP compliance for 30+ years
  • Support around the world
  • Line controller independency

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Shawn Opatka

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The pharma industry’s traceability movement

Benefits of MES systems as level 3 track-and-trace solutions

Counterfeit drugs have become an increasing global threat. In this article, published by Pharmaceutical Processing, Werum’s Jürgen Laskowski and Zaim Imeraj explain how track-and-trace solutions provide all necessary features for the serialization and aggregation of medical products in packaging processes. When integrated into MES drug manufacturers benefit from additional advantages of comprehensive production control and documentation, including equipment management.

 

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Secure track & trace system capabilities

Tracking is the process of monitoring products, by means of a secure marker (identifier), as they make their way to the consumer. In this way, a time and location history is built for each product.

Tracing is the concept of being able to intercept and authenticate products and trace their route back to the manufacturer. In this way, the time and location history of a specific product is retrieved.

Serialization is the unique identification of a medical product to avoid drug counterfeiting via printing a unique serialization number on packaging units e.g. 2D barcode, RFID tag.

PAS-X Track & Trace key functionalities

  • Support of GS1 labeling information
  • Management of modular packaging line layout including print layout recipe management
  • Management of serialization numbers in operations
  • Management of modular aggregation for e.g. item, bundle, pallets
  • Integration with centralized Track & Trace repositories using standards like EPCIS
  • Handling of packaging orders and batch information
  • Handling of mass data for serialization and aggregation processes
  • Dialogs to create, discard, aggregate and disaggregate units and hierarchies
  • User management including rights management & audit trail
    • Generation, randomization of serial numbers
    • Support of multiple serial number formats e.g. SGTIN-96
    • Providing serial number blocks to packaging lines
    • Recording and reconciliation of used and unused serialization numbers
  • Packaging Line Performance Management out of the box using T&T connectivity

PAS-X Track & Trace - system architecture

  • 21 CFR Part 11 and Electronic Product Code Information Services (EPCIS) compliant
  • Support of EPC Tag Data Standard for electronic product coding, e.g. SSCC, GTIN
  • Smooth standard integration with multiple Level 4 and Level 2 systems:
    • Line Controller: Antares Vision, Laetus, OCS, Optel Vision, Seidenader, Systech, Systec & Services, Uhlmann etc.
    • ERP Systems: SAP, ORACLE etc.
    • Central Repositories:
      • SAP (Advanced Track and Trace for Pharmaceuticals ATTP, Auto-Id Infrastructure AII, Object Event Repository OER),
      • IBM (Info Sphere Traceability Server ISTS, Websphere Sensor Events WSE),
      • Axway Track & Trace
  • Support of heterogeneous system landscapes
  • Multiple language/Unicode support

Why PAS-X Track & Trace

  • Vendor-independent line controller integration
  • Easy extension to the PAS-X Packaging Solution including EBR and KPI/OEE
  • Comprehensive product-based functionality out of the box
  • Compliance with all international anti-counterfeiting requirements, such as Korea (KD Code), China (preprinted serial numbers from CFDA), USA (DQSA H.R. 3204), Turkey (IST) etc.
  • Based on global standards e.g. GS1
  • Pre-configured standard solutions
  • Turnkey projects and "one-stop-shop" solutions for every customer
  • Experience from international deployments

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Werum is Open-SCS Working Group member

Logo Open-SCS

Driven by Healthcare Providers, the Open-SCS initiative directly addresses the Healthcare Industry’s Product Serialization Regulation Wave of the next decade. The Open SCS Working Group (Open-SCS) is partnered with the OPC Foundation to develop an open source standard in the Packaging Serialization Global Name Registry and an associated set of subscription-based work products. The open standard and work products are focused on the standardization of data exchanges for Healthcare packaging serialization and the aggregations between a Healthcare provider’s  enterprise serialization management function and their product packaging lines. This includes interfaces between Levels 2-to-3 and 3-to-4 for Level 2 plant (line and equipment) and supply chain packaging serialization activities (distribution centers (DC) and warehouses) and Level 3 functions (plant and warehouse operations management).

For more information, please look at the official OPC Foundation website or join the Open-SCS LinkedIn group.