MODA-EM: Paperless Environmental Monitoring, Utility & Product Testing
Automate your QC Micro data collection and management
MODA’s flagship software, MODA-EM™, is 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 leverages mobile computing technology and advanced visualization tools for increased operational efficiency, improved quality, and reduced costs. Manual, paper-based QC Micro laboratory processes can quickly eliminate high errors rates, redundancies, and excessive time and labor. MODA-EM serves as a regulatory compliant platform for managing and reporting on the full spectrum of EM and QC information—tests of surfaces, air, personnel, water, compressed gas, as well as product bioburden.
Manage entire EM/QC sample lifecycle
MODA-EM includes a comprehensive suite of functions to manage the entire EM/QC
sample lifecycle, such as:
• Automatic action and alert notifications
• Supervisory dashboard to track progress
• Reporting, trending and visualization of operational and regulatory information
MODA-EM integrates with standard monitoring equipment such as particle counters, total organic content (TOC) meters, and endotoxin devices, for direct data acquisition. An optimized GAMP 4 compliant implementation methodology and a suite of validation accelerators help get you into production quickly.
Offline capabilities
MODA-EM uses wireless technology for the paperless collection, processing and tracking of EM/QC 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, a 21 CFR Part 11 compliant data repository that serves as the complete system of record for all information.
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 QC 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 bioburden testing
MODA-EM™ System Requirements
Hardware
MODA-EM Servers: (2) Database and Application Servers |
|
Processor |
6-8 gigahertz (GHz) dual-core processor or faster recommended |
Memory |
4 GB or higher |
Disk |
80 GB or higher (includes requirements for application and database software) |
MODA-EM™ Client |
|
Processor |
1 gigahertz (GHz) or faster processor |
Memory |
1GB or higher |
Disk |
20 GB or higher |
Form Factor(optional) |
1024 x 768 touch screen display |
Environmental(optional) |
IP65 against dust and water (sealed unit) Housing impervious to sanitizing agents (IPA) |
Software
MODA-EM™ Server |
|
Operating System |
Windows Server 2003 or higher |
Web Server |
Internet Information Server 6 or higher |
Framework Tools |
Microsoft .Net Framework 3.5 SP1 or higher with ASP .Net 3.0 |
Database Software |
SQL Server 2005 Service Pack 1 or higher Oracle 9i (9.0.2) or higher |
MODA-EM™ Client |
|
Operating System |
Windows XP Professional SP2 or higher Windows XP Tablet PC Edition 2005 (for mobile PCs) |
Framework Tools |
Microsoft .Net Framework 3.5 SP1 or higher |
Interface Tools |
(For Oracle database) Oracle Data Access Components (ODAC) |
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