MODA-EM Paperless QC

MODA-EM® Paperless Quality & Manufacturing

The MODA-EM® Module is a regulatory-compliant paperless solution that automates quality processes. Users can easily manage and report on the full spectrum of EM and quality information — including surface, air, personnel, compressed gas and product testing.

Out of the box, the MODA-EM® Module seamlessly integrates with commonly used instrumentation automation technologies and media found in manufacturing facilities, as well as with laboratory information management systems (LIMS).

With this module, organizations get timely, accurate quality monitoring through location-based scheduling, mobile data collection, and paperless lab processing. Real-time access to data enables on-demand reporting, trending, and visualization capabilities for in-depth process analysis and ad hoc queries.

A dedicated quality solution

Built by quality personnel, for quality personnel. Delivers the efficiency, quality, and compliance that quality labs need.

Powerful analytics

Easily collate, trend, and visualize data with robust reporting and trending packages. Real-time access to your data at the click of a button. 

Seamless integrations

Extensive library of interfaces to devices, automation and IT systems to support connected operations. 

Automate QC Micro data capture & management

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
Making the Medicines of Tomorrow
Moda
MODA-ES®
Module v4.1
A scalable digitalization solution
for efficient manufacturing

MODA-ES® Module v4.1 Feature Sheet

Feature sheet describing added functionality of new v4.1 version of MODA-ES® Module.



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MODA® information or demo request

See how Moda’s MODA-EM® Platform can help you by facilitating paperless execution across manufacturing and quality processes.

Related resources

Case study
Building a digitalized end-to-end process for environmental monitoring
Learn about the first industry implementation of an end-to-end automated incubation and read-out process for EM, by leveraging the MODA-EM® Module with the Growth Direct System at four of Moda’s Cell & Gene Manufacturing Sites.

Download the case study

Case study
Microbiology and more: Unleashing the power of the MODA-EM® Solution
Nikon Cell innovation Co (NCLi) needed an IT solution for environmental monitoring. They implemented the MODA-EM® Solution, using its expanded functionality to eliminate the need for a separate Laboratory Information Management System (LIMS).


Get MODA-EM® case study

White paper
The gap between LIMS capabilities and QC microbiology needs
This paper discusses the challenges in customizing a LIMS solution to manage the workflows and data for QC microbiology.

Download white paper