Electronic Logbook System (eLogbook)

AmpleLogic’s Electronic Logbook System is an AI-powered solution designed for regulated industries such as pharmaceuticals, life sciences, food & beverages, cosmetics, gene therapy, and medical devices. It replaces traditional paper-based logbooks with intelligent digital logging, enabling real-time data capture, anomaly detection, and predictive maintenance. The system ensures compliance with global standards like FDA 21 CFR Part 11, EU Annex 11, MHRA, GAMP, GMP, and ISO, while improving operational efficiency, audit readiness, and data integrity.

Features

• Voice and text-based log entries for simplified data capture
• AI-driven anomaly detection to identify errors and compliance risks
• Predictive maintenance alerts to prevent equipment downtime
• Intelligent data insights for trend analysis and operational optimization
• Customizable templates to match unique workflows and regulatory needs
• Real-time regulatory insights and audit trail generation
• Centralized logbook management across departments and equipment
• Seamless integration with existing enterprise systems

Capabilities

• Digitization of manual logbooks with secure, audit-ready records
• Consolidation of multiple logbooks into a unified platform
• Role-based access control and electronic signatures
• Real-time monitoring and reporting of operational activities
• Data encryption and cybersecurity measures for sensitive information
• Scalable architecture for enterprise-wide deployment
• Support for multilingual environments and global teams

Benefits

• Enhances compliance with international regulatory standards
• Improves operational efficiency and reduces manual errors
• Minimizes downtime through predictive maintenance
• Strengthens data integrity and traceability
• Reduces administrative overhead and documentation costs
• Accelerates audit readiness and simplifies inspections
• Supports digital transformation and paperless operations