Case Study

Electronic Batch Reporting

Source: HighByte
GettyImages-1327112218 Scientist using a laptop in a laboratory

In the life sciences sector, manufacturers understand the importance of accurate batch reporting. The Food and Drug Administration (FDA) imposes stringent requirements regarding the type of information that must be recorded and accessible. FDA record-keeping requirements under 21 CFR 211.188 include an accurate reproduction of production or control records as well as the documentation of manufacturing steps for each batch. This documentation needs to contain production dates, the identity of equipment/lines used, weights, the identity of people supervising operational processes, labeling control records, yield statements, and measures of components used during the process.

Electronic batch reporting (EBR) streamlines the process for manufacturers, eliminating time-consuming manual data entry and validation and minimizing the potential for human error. Discover how an Industrial DataOps software solution that allows users to assemble data into EBR payloads in real time enabled a pharmaceutical CDMO to automatically create a comprehensive batch report model to drive their reporting and speed root cause identification of quality failures.

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