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Lonza MODA-ES® Execution System

The MODA-ES® Electronic Batch Record Execution Platform is a comprehensive solution that bridges the gap that currently exists between manufacturing and QC to provide a single batch record with an intuitive review and approval interface. With GMP compliance and tracking at its core, the MODA-ES® Platform combines data capture and error prevention with the flexibility to capture and trend key quality and performance metrics, both in the lab and on the production floor.

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Replace Paper with Productivity - Innovative Approach to Electronic Batch Records

 

The MODA-ES® Electronic Batch Record Execution Platform is a comprehensive solution that bridges the gap that currently exists between manufacturing and QC to provide a single batch record with an intuitive review and approval interface.  With GMP compliance and tracking at its core, the MODA-ES® Platform combines data capture and error prevention with the flexibility to capture and trend key quality and performance metrics, both in the lab and on the production floor. 

 

Designed to be configurable over customizable, the MODA-ES® Electronic Batch Record Platform’s interface is easy-to-use enabling manufacturing technicians who understand the processes to build the workflows. The configuration of the system includes areas for data recordation (measurements), instructional text (including hyperlinks to SOP’s), electronic signatures, sections, and drag and drop workflow. This electronic batch record system was built with a modular design that allows individual modules to be validated and data transfer between modules is a configuration verification exercise. This limits the amount of work when a new process is brought into a facility because you can use existing validated modules and only create modules needed for the new process. Additionally the MODA-ES® Electronic Batch Record Platform provides a library feature that allows products of the same family to be processed the same way, but with variable differences such as raw materials, fill volumes, and equipment types without needing a completely new process to be built and validated.

 

The MODA-ES® Electronic Batch Records Software Platform has been designed to provide a cost- effective solution to batch record challenges. Electronic batch records have been unattainable to most of the industry due to cost constraints and flexibility concerns.  Leveraging Lonza’s unique manufacturing, quality control and informatics expertise the MODA-ES® Electronic Batch Record Execution Platform provides a solution to the industry that is flexible and easy to configure at a price point that allows the entire manufacturing industry to go paperless.

 

The MODA-ES® Platform bridges the gap that currently exists between manufacturing and QC to provide a single batch record with an intuitive review and approval interface.  With GMP compliance and tracking at its core, the MODA-ES® Platform combines data capture and error prevention with the flexibility to capture and trend key quality and performance metrics, both in the lab and on the production floor. The MODA-ES® Platform provides a solution to the industry that is flexible and easy to configure at a price point that allows the entire manufacturing industry to go paperless.

 

Benefits at a Glance

  • Affordable with a lower total cost of ownership and flexibility to scale without compromising quality or compliance
  • Easy and Rapid Deployment leveraging a modular design allowing individual modules to be created, validated and used across different processes. Create standard methods for processing products of the same family, with the flexibility to vary the raw materials, fill volumes and equipment types used 
  • User Friendly Design built to meet the needs of the end user with workflow driven data entry applicable to batch records, sterility test and cleaning forms
  • Expedited Review and Approve with an electronic check list easily navigated and deviation alerts to trigger timely intervention and resolution of issues
  • Seamless Integration with other cGMP compliant electronic systems, as well as with analytical equipment, for effortless, reliable data transfer

For more information or ordering, please email us at cs@medikonia.com.