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Vimachem / Level 3 SSM and TraceLink Life Sciences Cloud

A Powerful Fully Integrated Serialization Solution

Vimachem Level 3 Serialization Site Manager - TraceLink

The Vimachem Level 3 Serialization Site Manager was designed in collaboration with TraceLink, to be fully integrated with the TraceLink Life Sciences Cloud.

The full integration between the Vimachem Level 3 SSM and TraceLink, allows all daily serialization operations (including commissioning and sending data to marketing authorization holders) to be performed from the Vimachem Level 3 SSM user interface. This enables internal teams to use one serialization software system for all daily serialization tasks, reducing risk, compliance, and training requirements.

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Vimachem / Level 3 SSM and TraceLink Life Sciences Cloud Modules and Features:

Below is the list of the Vimachem Level 3 SSM modules and features deployed in joint installations with the TraceLink Life Sciences Cloud.

  • Automated Product Master Data Transfer (featuring market’s only automatic data transfer verification compliant with Eudralex Annex 11 Computerized Systems Section 4)
  • Tracelink Repository Configuration
  • Native Tracelink XML Protocl
  • Smart Warehouse Traceability (SWT)
  • Vimachem L3 SSM – Tracelink Common User Level Management
  • Data Integrity System Checks
Key Benefits Due to the Vimachem Level 3 SSM Modules and Features for the TraceLink Life Sciences Cloud

Reduced implementation time (6-8 weeks from project kick-off) for Vimachem Level 3 SSM Optimized risk management based on the GAMP5 risk-based methodology.

Operational efficiencies that include:

  • Up to 45% increase in serialization systems Overall Equipment Effectiveness (OEE)
  • Up to 50% fster order commissioning
  • Up to 200% faster master data transfer

Lean (pragmatic) end-to-end validation that includes interfaces to Level 2 and Level 4.

Vimachem Level 3-5 Implementation and Support Services

Vimachem is a certified TraceLink Implementor and offers Level 3 to 5 (Vimachem Level 3 SSM and TraceLink Life Sciences Cloud) implementation, validation, and post-go-live support services.

A. PROJECT MANAGEMENT AND IMPLEMENTATION SERVICES
  • Our team of technical experts will provide support with project management and implementation services for Levels 3 to 5
  • Two technical resources (implementation project manager and technical consultant) are assigned to each project to support Level 3 implementation and qualification
Tracelink Post Go-Live Support Services

The Vimachem support team, certified by TraceLink, offer support services for the Vimachem Level 3 SSM and also offer post-go-live support services for TraceLink that include:

  • Country Compliance Modules Implementation, Support, and Updates
  • Partner Onboarding Services
  • Master Data Updates and Review
  • TraceLink Life Science Cloud Support & Operational Package
  • Alerts Management Services
  • User Helpdesk
  • TraceLink UI Administration Info Exchange Monitoring
  • Informal Usage Training