Level 3 Serialization Site Management (SSM)

Level 3 Serialization Site Management (SSM)

The VIMACHEM Level 3 Serialization Site Management (SSM) is a complete serialized plant operations system that provides operational efficiencies and compliance with anti-counterfeiting requirements around the globe.

The Vimachem Level 3 Serialization Site Management (SSM) system was designed and developed in collaboration with Tracelink to be fully integrated with the Tracelink Life Sciences Cloud. It receives data from Tracelink and allocates work orders issued manually or by the ERP to the line level equipment (multiple line level providers are supported).

After the production process is completed, the level 3 system receives production data from the packaging lines along with statistics, serialization results and audit trail and sends back to Tracelink all relevant data. Tracelink then distributes all required information to the European Medicines Verification Organization (EMVO) and brand owner customers.

Key Features include:

  • Horizontally scalable supporting a virtually unlimited number of lines.
  • Enhanced work order management, including work order scheduling, pause, resume and transfer work order between lines.
  • Fully integrated with OCS, Scanware and Tracelink allowing efficient data flow (e.g. OCS / Scanware audit log, OCS weight information, Tracelink user accounts) and lean (pragmatic) end-to-end validation.
  • Support of multiple serial number formats including SGTIN, NTIN, CN-EDMC (China), and SSCC.
  • Management of modular aggregation for e.g. item, bundle, pallets
  • Print Layout management with support for GS1 labeling information.
  • ERP connector for product master data and work order information retrieval.
  • Production reporting including serial number disposition.
  • Big data storage capability allowing billions of serial numbers to be safely stored, thousands of transactions each month to be managed.
  • Utilization of customer’s existing authentication infrastructure supporting:
    • Active Directory Accounts
    • Tracelink User Accounts
  • User management including rights / privileges management & audit trail according to:
    • 21 CFR Part 11,
    • EU Annex 11 regulations
    • GAMP5 guideline
    • EU 2016/161
  • Microsoft Excel & Power BI connectors for OEE and Site Analytics.
  • Multilingual Interface: English, German, French

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PRODUCTS

Level 3 Installation, Validation Execution & Project Management


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Level 3 Qualification Documentation and Validation Plan


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Level 3
Annual Support


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