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LabMonitor

Continuous monitoring and secure storage of lab/instrument files with version control, workflow automation, and 21 CFR Part 11 compliance.

Solution by CIMCON Software
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Overview

LabMonitor, developed by CIMCON Software, is a lab and instrument software remediation solution built specifically for and in close collaboration with the life sciences industry. It is designed to automatically secure laboratory and instrument files through continuous monitoring of lab folders, providing organizations with reliable data integrity, regulatory compliance, and streamlined lab management.

LabMonitor addresses the critical needs of life sciences laboratories by combining file protection, version control, access level controls, and full 21 CFR Part 11 compliance — including a comprehensive audit trail of all changes. It is an ideal solution for labs seeking to enhance productivity while maintaining strict regulatory adherence.

Key Benefits

  • Continuous data monitoring to ensure files are tracked in real time.
  • 21 CFR Part 11 compliance to meet regulatory requirements for electronic records and signatures.
  • File protection and archiving to safeguard critical laboratory data.

Core Features and Capabilities

  • Continuous Monitoring: Monitors network folders for instantaneous file tracking, ensuring no changes go undetected.
  • Secure Storage: Organizes files, documents, and other content in a centralized repository for easy access and management.
  • Version Control: Manages multiple file versions while maintaining a single version of the truth, with one-click version comparison for quick review.
  • Workflow Designer: Enables users to create custom workflows in minutes and configure email alerts upon task completion, supporting efficient lab processes.
  • Data Management: Allows configuration of tables with columns, field types, valid ranges, and picklists to structure and validate laboratory data.
  • Collaboration: Facilitates knowledge capture through Notes, Discussions, and Logs, and supports linking of related documents to maintain context across projects.
  • Search: Provides powerful search capabilities across file text, attributes, content, notes, and more, enabling rapid retrieval of information.
  • Part 11 Compliance: Incorporates security controls, audit trails, and electronic signatures to fully support 21 CFR Part 11 requirements.

LabMonitor is part of CIMCON Software's Enterprise Series and is purpose-built for life sciences organizations that require robust regulatory compliance alongside practical, day-to-day lab management functionality. Its combination of automated monitoring, secure centralized storage, and configurable workflows makes it a comprehensive platform for modern laboratory environments.

Meta

Domain
Quality, Compliance & Regulatory
Subdomain
Computer System Validation (CSV)
Software type(s)
Record-Keeping System
Deployment type(s)
On-Premise
Industry vertical(s)
PharmaBiotechCRO
Development stage(s)
ManufacturingPreclinical / Pre-MarketResearch & Discovery
Target user(s)
Lab Manager / Core Facility ManagerQA / Regulatory AffairsIT / Systems Admin / Data Engineer
Compliance standard(s)
21 CFR Part 11GxP