// Site Manager (SSM)

Level 3 Installation, Validation Execution & Project Management

// Track & Trace

End-to-end Serialization support

Our team of expert consultants will partner with your organization to provide complete end-to-end Serialization (Track & Trace) support that you need to achieve cost-effective compliance.

We bring world class expertise and support developed from 10+ years of support dedicated to the Life Sciences industry.

Our expert technical consultants and project managers will support your organization with the implementation and qualification of the VIMACHEM SSM Level 3 system as well as with the implementation of the Tracelink Life Sciences Cloud (Levels 4 and 5), offering an integrated solutions for serialization Levels 3 to 5 that allows reduced implementation time and (pragmatic) end-to-end validation.

During installation and validation execution Vimachem will:

Install the Vimachem Level 3 Serialization Site Management (SSM) system to two servers (production and test) and perform the installation qualification (IQ).

Integrate the VIM level 3 site management system to the Tracelink Life Sciences cloud and the line level equipment and perform the installation qualification (IQ).

Support if requested, with production qualification (PQ).

Vimachem throughout the project lifecycle will provide project management services for:

  • Project coordination and communication with global stakeholders.
  • Technical requirements and specifications definition.
  • URS analysis.
  • Scheduling of time and resources, monitoring and change management, continuous monitoring of project milestones.

After the successful qualification of the level 3 site management system, Vimachem will train the resources in the successful operation of the Level 3 site management.

GMP Execution

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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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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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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From scattered documents to controlled compliance at scale.

Centralize document creation, approval, and version control. Ensure teams always follow the latest SOPs.

GMP Efficiency

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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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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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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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.

From missed tasks to reliable, real-time execution.

Assign and track critical shop-floor tasks with live dashboards, compliance checks, and alerts. Ensure nothing slips between shifts or across departments.

From disconnected machines to unified shop floor intelligence.

Capture real-time data from any machine or line. Securely transmit and integrate with MES for visibility, traceability, and predictive analytics.

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Track & Trace

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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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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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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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.

Learn more
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.

Learn more
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.

Learn more
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.

Learn more
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.

Learn more
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.

Learn more