MODA-EM^® Paperless Quality & Manufacturing

The MODA-EM^® Module provides a paperless environmental monitoring (EM) solution for the Life Sciences industry that automates quality control microbiology (QC Micro) data collection and management, including utility and product testing. MODA-EM^® Software leverages mobile computing technology and advanced visualization tools for increased operational efficiency, improved quality, and reduced costs. Streamlined, paperless QC Micro laboratory processes enable opportunities to quickly eliminate high error rates, redundancies, and excessive time and labor.

The MODA-EM^® Module serves as a regulatory compliant platform for managing and reporting on the full spectrum of EM and quality information — tests of surfaces, air, personnel, water, compressed gas, and products.

Manage end-to-end sample lifecycle 

The MODA-EM^® Module includes a comprehensive suite of functions to manage the entire EM/quality sample lifecycle, such as:

• Automatic action and alert notifications 
• Supervisory dashboard to track progress 
• Reporting, trending and visualization of operational and regulatory information

The MODA-EM^® Platform integrates with standard monitoring equipment such as particle counters, total organic content (TOC) meters, and endotoxin devices, for direct data acquisition. An optimized implementation methodology and a suite of validation accelerators help get you into production quickly.

Offline capabilities 

The MODA-EM^® Platform uses wireless technology for the paperless collection, processing and tracking of EM/quality samples. Proprietary offline capabilities enable technicians to work even if disruption to your wireless network connectivity occurs. All cached information is automatically synchronized with the MODA-EM^® Server Data Repository. The solution is 21 CFR Part 11 compliant for technical requirements and serves as the complete system of record for all information.

MODA-EM^® Platform features and benefits 

• Eliminates paper records, data reconciliation and batch data entry 
• Administrative tools define parameters that govern system operation and security 
• Flexible, user-friendly planning and scheduling tools ensure compliance with quality guidelines and SOPs 
• Automated workflow engine enforces compliance with SOPs and manages the entire sample lifecycle 
• Robust reporting and trending package produces accurate and meaningful analyses 
• Manages entire spectrum of EM, utility, and product testing

The MODA-VIP^® Module is a visual analysis tool that correlates production-related information with a floor plan of your physical facility, resulting in improved insight into your manufacturing operation. MODA-VIP^® Software plots environmental monitoring, utility monitoring and other production information over a specified date range, and filters that information based on criteria, such as sample type, organism type or severity level. Color-coded symbols — which represent various conditions — are overlaid onto a map of the facility — providing a snapshot on the state of the facility at any point in time. The symbols can also be examined to view, print and trend the source data. 

Filtering and sorting 

The MODA-VIP^® User Interface is intuitive and easy-to-use. Using the filtering, sorting and drill down capabilities, managers and supervisors can quickly prepare analyses tailored to their specific needs without manually extracting, manipulating or formatting the underlying data. Decision makers gain more time to analyze information and make proactive and informed decisions keeping operations running smoothly. 

Visual tracking and trending

The MODA-VIP^® Module provides lab analysts with the visualization of spatial and temporal distributions of environmental monitoring (EM) and quality control (QC) excursions as well as the visual tracking of EM/quality trends by a facility location. MODA-VIP^® software is compatible with facility maps developed with industry standard drawing packages such as AutoCAD^® and Visio^®. 

Features and benefits 

• Visual representation of production-related data within the context of the physical facility 
• Intuitive user interface with flexible data filtering and sorting capabilities 
• Visualize information at a facility level or drill down into detailed information for specific locations 
• Transform visual map to a tabular report and export to spreadsheet with the click of the mouse 

Collect, label and track test samples for EM, utilities and products 

The MODA-FDC^® Platform efficiently collects, labels (via barcode) and tracks environmental monitoring (EM), utility and product bioburden test samples.

The MODA-FDC^® interface can be used on a cleanroom-compatible tablet PC and has the ability to work offline to ensure contemporaneous data collection.