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Caliber DigiLabel

Digital label display for GMP/GLP compliance, automating instrument status tracking and sample preparation workflows with real-time data and audit trails.

Solution by Caliber
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Overview

Caliber DigiLabel is a digital label display solution designed for pharmaceutical and life sciences laboratories conducting GMP and GLP activities. It replaces traditional paper-based labeling with a fully digitalized ecosystem, enabling labs to manage instrument status, sample preparations, and compliance workflows more precisely and efficiently.

The platform is purpose-built for regulated environments, offering end-to-end digitalization of label management with real-time data mapping, audit trail maintenance, and seamless integration with existing laboratory systems and workflows. Its intuitive interface, configuration flexibility, and scalability make it suitable for labs of varying sizes and complexity.

Core Capabilities

  • Digitalized Labels: Transition from physical paper labels to fully digital versions, streamlining lab processes and increasing overall efficiency while eliminating paper label waste.
  • Complete Automation: Ensure accurate and timely updates on instrument statuses, covering everything from calibration labels to availability status labels, with effortless monitoring and customization.
  • Real-Time Displays: Data is mapped directly from the source and displayed as updated lab activities, ensuring data integrity at all times without requiring users to manually log in for status checks.
  • Traceability Assurance: Monitor end-to-end logs, track label changes easily, and maintain an always-updated inventory. Comprehensive audit trails help meet GLP requirements.
  • Drag-and-Drop Label Design: An easy drag-and-drop design interface allows users to customize, configure, and integrate labels to meet specific laboratory needs, with quick parameter updates to support smooth lab activities.

Compliance and Integration

  • Adheres to electronic labeling standards under FDA 21 CFR 820, supporting GxP compliance across all environments.
  • Accurate audit trails enable faster GxP approvals, directly contributing to improved lab efficiency.
  • Seamless integration with any systems or workflows via a standard configuration and display device layer, allowing end users to easily enable or configure the system.
  • Feature consistency is maintained across all environments, ensuring reliable compliance management.

User Experience and Workflow Benefits

  • User-Friendly Interface: The electronic label system is designed for ease of operation, promoting seamless interaction with connected systems.
  • Activity Trail Control: Users can control activity trails and define mapping rules to maintain compliance throughout all GLP/GMP activities.
  • Paperless Auditing: Eliminates the need to discard and reprint paper labels in response to changing auditor requests, saving time and reducing waste.
  • Scalability and Flexibility: The platform's configuration flexibility and scalability support a wide range of laboratory environments and operational requirements.

Caliber DigiLabel is deployed as an integrated digital ecosystem with a standard display device layer, making it straightforward to configure and roll out across laboratory environments. It is particularly well-suited for pharmaceutical labs seeking to accelerate GxP approvals, maintain continuous compliance, and modernize their label management processes.

Meta

Domain
Lab Informatics & Operations
Subdomain
Pharmaceutical GMP Lab Compliance
Software type(s)
Workflow Automation
Deployment type(s)
On-Premise
Industry vertical(s)
PharmaBiotech
Development stage(s)
Preclinical / Pre-MarketManufacturing
Target user(s)
Bench Scientist / Lab TechnicianLab Manager / Core Facility ManagerQA / Regulatory Affairs
Compliance standard(s)
21 CFR Part 11GxP