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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 Full Integration with Tracelink
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
Vimachem Level 3 SSM Full Integration with Tracelink

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
Changeover Instructions & Analytics

Changeover Instructions & Analytics

From downtime drag to agile, data-driven changeovers.
Digitize and streamline changeovers with guided instructions and real-time feedback. Cut changeover times and reduce variability while capturing execution data for continuous improvement.

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A Modular Platform. A Unified Ecosystem.

Manufacturing Analytics & OEE

From guesswork to real-time performance insights.
Track line performance, equipment efficiency, and downtime trends. Real-time dashboards give operations, maintenance, and Continuous Improvement teams the insights they need to improve continuously.

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Manual Aggregation Module (ΜΑΜ)

Manual Aggregation Module // ΜΑΜ

From disconnected rework to streamlined, compliant aggregation.
Easily aggregate serialized units on manual or offline lines. Support sampling, returns, and rework while maintaining full compliance, traceability, and seamless integration with existing systems.

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Smart Warehouse Traceability (SWT)

Smart Warehouse Traceability // SWT

From siloed systems to full material traceability.
Track every material, lot, and movement from warehouse to batch. Android-compatible, ERP-integrated, and scalable, so you’re always audit-ready and inventory-aligned.

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Serialization Site Manager

Serialization Site Manager // SSM

From regulatory complexity to centralized serialization control.
Manage global serialization and aggregation across hundreds of lines. Integrates with any vendor, supports global standards, and provides real-time oversight at site and enterprise level.

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Electronic Logbooks (eLog)

Electronic Logbooks // eLog

From paper logs to intelligent, mobile-ready records.
Digitize equipment and process logs to ensure compliance and audit-readiness. Configurable templates, mobile data entry, and real-time access reduce manual effort and boost data integrity.

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Digital Work Instructions

Operator Training

From tribal knowledge to consistent execution across shifts.
Deliver smart, digital SOPs to frontline teams. Improve adherence, minimize training time, and standardize operations with traceable, real-time guidance.

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Weigh & Dispense (W&D)

Weigh & Dispense // W&D

From inconsistent weighing to verified-first-time accuracy.
Digitally guide operators through material weighing and dispensing. Improve accuracy, ensure traceability, and connect seamlessly with inventory and batch records.

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Electronic Batch Records (eBR)

Electronic Batch Records // eBR

From error-prone paperwork to accelerated, compliant batch release.
Automate batch execution and review with built-in compliance. Reduce errors, eliminate manual logging, and shorten release cycles – so quality teams can focus on quality, not backlogs.

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Bulk Production Analytics (BPA)

Bulk Production Analytics // BPA

From fragmented visibility to upstream process control.
Gain real-time insight into blending, granulation, and other bulk operations. Identify variability, reduce waste, and maintain consistent process quality.

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