Electronic Batch Records in Medical Supply Manufacturing Overview A major medical manufacturer of intravenous (IV) solution bags engaged Grantek to upgrade a production line making bags of IV fluids. This company had developed an electronic batch record (EBR) system in-house using Oracle. The production line upgrade project also required that the new equipment provide batch record data compatible with the existing EBR system. Challenges As part of the line upgrade effort, Grantek ensured data available from the new line equipment would remain compatible with the in-house developed EBR system. The customer needed to track identification and status for each batch of IV fluid bags produced on the line, by lot and by batch. This was necessary so that alerts coming from the line were associated

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