Lonza’s next-generation electronic batch record execution platform, the MODA-ES Software Platform, offers a flexible solution for consolidating and managing batch and quality data produced across cell and gene therapy manufacturing processes.
The software platform has been designed to consolidate all cell and gene therapy manufacturing batch data, as well as batch-related quality control data, into a single record with an easy-to-use review and approval interface for expedited product release. With data integrity compliance and traceability at its core, the platform captures trends key quality and performance metrics, while eliminating errors associated with manual and paper-based approaches. It is flexible, easy to configure and scalable from clinical through to commercial production.
The product enables workflow-driven data entry applicable to batch records, sterility tests and cleaning forms. Its modular design allows individual modules to be created, validated and used across different processes.
Standard methods are available for processing products of the same family, with the flexibility to vary the raw materials, fill volumes and equipment types used. An electronic checklist enables real-time review and approval, while a data-integrity alert capability is available to trigger timely intervention and resolution of issues.
The platform seamlessly integrates with other cGMP compliant electronic systems, as well as with analytical equipment, for effortless data transfer.
Phone: 1300 657508
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