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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