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electronic batch record

The Next Generation Electronic Batch Record

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-ESTM 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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Designed to be configurable over customizable, the MODA-ESTM 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-ESTM Electronic Batch Record Platform provides a library feature that allows products of the same family to be processed the same way, but with various differences such as raw materials, fill volumes, and equipment types without needing a completely new process to be built and validated.