Quality Management

A customer-focused quality management system

// For maximum customer satisfaction

Our intelligent MES IIoT-driven platform is designed specifically for life sciences and is cGMP and 21 CFR Part 11 compliant. Go from planning to product delivery seamlessly, while maintaining compliance so that critical drugs get to market safer and faster.

Change Management

Updates, new releases, new versions are integrated in our products following GxP requirements.

Validation & Market Release

We ensure to provide to our customer validated solutions. Our team tests with documented evidence new or updated products prior to release to the market.

Documentation, Compliance & Technical Knowledge

We leverage the technical knowledge of our consultants during the development of new products in order to provide you a series of high-level, user-friendly documents.

Continuous Support & Connection With Our Customers

Real-time communication system in order to provide guidance & support to our customers in their processes. We provide a ticketing system where you can view at all times the progress of your request and interact in real-time with our consultants.

Regulatory Support

Vimachem can provide you regulatory support in your pharmaceutical track & trace processes including technical onboarding, track & trace events reporting across a multitude of markets.

Training Sessions

Vimachem ensures continuous training for our consultants in order to stay updated with the regulatory requirements and the latest trends.

In addition, Vimachem organizes training sessions for your team about:

A.
GxP Validation & Compliance

B.
Regulatory expectations for specific markets

C.
Integration with your Quality Management System

  • We have developed the Quality Management System centered around the customer needs.
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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