MODA Technology Partners
MODA-EM™ is an integrated software and hardware solution that improves the performance of Environmental Monitoring (EM) operations by eliminating inefficiencies and reducing the error rates inherent in manual, paper-based systems. By removing low value and redundant activities from EM 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 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 samples. An automated workflow engine drives the location-based sampling regimens – improving productivity and ensuring compliance with standard operating procedures. The system includes proprietary "severability" 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 information.
MODA-EM also includes a comprehensive suite of functions to manage the entire EM 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. - A GAMP-compliant implementation methodology and suite of validation accelerators help get the system into production quickly and with minimal risk.
• Mobile data acquisition platform eliminates paper records, data reconciliation and batch
• Administrative tools define parameters that govern system operation and security
• Automated workflow engine enforces compliance with SOPs while managing the entire
• Supervisory dashboard provides real time visibility into laboratory workload,
processing and throughput
• Robust reporting and trending package produces accurate and meaningful analyses
• Management of entire spectrum of EM, utility and product bioburden testing
“The elimination of paperwork had a tremendous impact on the operation. We gained back the time that we had previously spent compiling, routing, reviewing, and filing paper forms.”
Associate Director of Quality Control Microbiology
ImClone Systems Incorporated
MODA-FDC™ (Field Data Capture) is a mobile computing platform for collecting, labeling (via barcode) and tracking environmental monitoring samples.
MODA-FDC consists of MODA-EM™ Client software, a rugged tablet PC, barcode scanner, barcode printer, badge reader and stainless steel cart that can be used to store and transport sampling media and equipment (such as airborne particle counters). The entire configuration (PC, peripherals and cart) can be sanitized using standard chemical disinfectants without harming the devices. The rugged PC operates without a fan and the thermal printer produces no dust to conform to clean room standards.
“We selected a solution that will not only automate our environmental monitoring program but also facilitate the transformation to a completely paperless operation. We feel that the improvements in productivity and regulatory compliance that will result from the MODA-EM™ implementation will enhance our competitive position within the contract manufacturing market.”
Tim Coleman, PhD
Senior Director QC/Testing Services