CaliberLIMS

CaliberLIMS is a comprehensive Laboratory Information Management System (LIMS) developed by Caliber Lab Solutions, designed to drive digital transformation in pharmaceutical laboratories. Recognised as a pioneer in establishing the first 100% paperless laboratory in India, CaliberLIMS is purpose-built for complex, future-ready lab environments operating under stringent regulatory requirements. The platform is fully compliant with FDA 21 CFR Part 11, MHRA, and other major regulatory agencies, ensuring uncompromised data integrity, traceability, and audit readiness across all laboratory operations.

CaliberLIMS is part of a broader portfolio of laboratory solutions aimed at enabling Pharma 4.0 — empowering pharmaceutical organisations to achieve sustainable, efficient, and agile laboratory operations. The suite includes AI-powered analytics, environmental monitoring, instrument integration, and digital labelling capabilities, all designed to work together within a connected digital lab ecosystem.

Core LIMS Capabilities

• End-to-end sample management with workflow automation, lifecycle tracking, and location-based inventory management
• Stability management with customisable scheduling, automated reminders, integration capabilities, and a user-friendly interface for compliant stability studies
• Out-of-Trend (OOT) configuration allowing users to set OOT limits per test and specification using 3-sigma or custom range methods, including stability initial sample and previous station comparisons
• Dossier generation enabling batch-wise electronic booklets compiling all relevant documents from sample login through batch release, including COA, raw data, instrument reports, and vendor reports, with password-protected output and selective document submission
• Analyst Qualification Module covering both complex and non-complex techniques, with complex techniques evaluated against released batch execution and additional qualification limits, and non-complex techniques assessed via discussion and Q&A methodology
• Reserve Sample Management for maintaining reserve sample inventory, tracking quantities withdrawn and returned, recording withdrawal purposes, scheduling visual inspections per defined frequency and checklist, and managing sample destruction
• Glassware Management covering registration of glassware types and lots, lot acceptance, issuance, usage tracking, and QR code-based tracking for easy identification and reporting

Instrument Integration and Data Management

• Seamless integration across all laboratory instruments to manage, monitor, and track quality control data
• API-driven connectivity enabling automated data entry and smooth data flow across diverse sources and systems
• Quality Command Centre (QCC) providing real-time data capture and analysis from Chromatography Data System (CDS) instruments to optimise lab performance and enhance productivity

Environmental Monitoring

• CaliberEMpro offers stand-alone environmental monitoring with a focus on microbial trend analysis
• Delivers accurate, timely, and actionable data through a fully digital monitoring solution to increase lab productivity

Digital Labelling and Compliance

• Caliber DigiLabel provides end-to-end digitisation of label management for all GLP/GMP activities
• Fully integrated ecosystem for label tracking with activity trail control, mapping rule definition, and GxP compliance maintenance
• Scalable and intuitive platform ensuring traceability and regulatory compliance throughout label lifecycle

AI-Powered Analytics with Cal Genie

• Cal Genie is an AI-powered information platform that integrates with LIMS, QMS, MES, and other enterprise systems
• Provides instant access to critical pharma analytics, reports, and calculations tailored to specific processes and products
• Features a simple interface with voice-controlled functionality to promote speed, precision, and informed decision-making

CaliberLIMS and the broader Caliber Lab Solutions portfolio are designed for pharmaceutical laboratories seeking full regulatory compliance and digital maturity. The platform supports integration with existing enterprise systems and is built to scale with evolving industry requirements, making it a robust foundation for laboratories transitioning to Pharma 4.0.