MODA Technology Partners

MODA-EM™

Paperless Environmental Monitoring

MODA-EM™ is an integrated software and hardware solution that improves the performance of Environmental Monitoring (EM) and Quality Control (QC) operations by eliminating the inefficiencies and reducing the error rates inherent with manual, paper-based systems. By removing low value and redundant activities from EM and QC processes, the system delivers a tangible return on investment while serving as a regulatory compliant platform for managing and reporting on the full spectrum of EM and QC information including tests of surfaces, air, personnel, water, compressed gas, as well as product bioburden.

Using wireless technology, MODA-EM provides a mobile computing platform for the paperless collection, processing and tracking of EM and QC samples. An automated workflow engine drives the location-based sampling regimens – improving productivity and ensuring compliance with standard operating procedures. The system includes proprietary "offline" functionality that allows sampling technicians to continue working despite any potential disruption in wireless network connectivity. Once connectivity is restored, all cached information is automatically synchronized with the MODA-EM server, a 21 CFR Part 11 compliant data repository that serves as the complete system of record for all environmental monitoring and quality control information.

The system also includes a comprehensive suite of functions to manage the entire EM/QC sample lifecycle, provide automatic action and alert notifications, track progress via a supervisory dashboard, and report, trend and visualize EM information for both operational and regulatory purposes. To further streamline operations, the system can be easily integrated with standard monitoring equipment such as particle counters for direct data acquisition. An optimized GAMP 4 compliant implementation methodology and suite of validation accelerators help get the system into production quickly and with minimal risk.

MODA-EM™ Features

• Mobile data acquisition platform eliminates paper records, data reconciliation and batch data entry
• Administrative tools define parameters that govern system operation and security
• Flexible and user-friendly planning and scheduling tools ensure compliance with QC program guidelines and SOPs
• Automated workflow engine enforces compliance with SOPs while managing the entire sample lifecycle
• Robust reporting and trending package produces accurate and meaningful analyses
• Management of entire spectrum of EM, utility, and product bioburden testing

MODA-EM™ System Requirements

Hardware Requirements

Software Requirements