Environmental Monitoring System (EMS)

AmpleLogic’s Environmental Monitoring System (EMS) is an AI-powered solution designed for regulated industries such as pharmaceuticals, biotech, and life sciences. It enables real-time monitoring of environmental conditions, ensuring compliance with global standards like FDA 21 CFR Part 11 and EU Annex 11. The system helps detect microbial contamination, track incubation data, and identify contamination sources, safeguarding product quality and audit readiness.

Features

• Real-time monitoring of environmental parameters
• Automated alerts for deviations and limit breaches
• Integration with existing systems and sensors
• Tracking of incubation and microbial sampling data
• Contamination source identification (HVAC, personnel, etc.)
• Compliance with SOP-defined sampling frequencies and locations
• Intuitive interface for easy navigation and operation
• Real-time report generation for audits and decision-making
• Scalable architecture for expanding monitoring needs

Capabilities

• Detects and quantifies microbial contamination
• Tracks environmental conditions across multiple zones
• Supports various sampling methods (air, surface, settle plates)
• Enables proactive corrective actions through instant alerts
• Consolidates monitoring data for analysis and compliance
• Integrates seamlessly with lab and manufacturing systems
• Provides audit trails and electronic signatures
• Enhances traceability and data integrity

Benefits

• Ensures regulatory compliance and product safety
• Reduces risk of contamination and batch rejection
• Improves operational efficiency and responsiveness
• Enhances audit readiness and documentation accuracy
• Minimizes manual monitoring errors and delays
• Supports continuous improvement and quality assurance
• Saves costs through automation and early issue detection
• Enables scalable monitoring across facilities