An Electronic Batch Record (EBR) is a digital production record, an electronic record of a production, an electronic copy or reproduction from a Master Batch Record (MBR). The electronic batch record provides evidence that the production was conducted in accordance with the applicable instructions.
The EBR record also demonstrates that the organization properly handles and records all critical steps in the production of each batch of product, whether entered electronically or manually. This record contains data related to operators, manufacturing process, equipment, materials, and supplies. It may also contain data from laboratory information management systems (LIMS), enterprise resource planning (ERP), process control systems (PCS) and others.
Unlike analog, paper-based, defined batch records, electronic batch records enable an organization to see the benefits of improved data integrity and accuracy, streamlined processes and efficient operations.
Optimizing these processes provides better resource management, improved inventory management and reduced material waste – all of which positively impact the bottom line of the operation.
It is critical to assess the following areas:
- People (organizational culture)
- Business processes
The acronym EBR, can also refer to an end-to-end information system that allows for the electronic recording of batch records as a copy or reproduction from a master batch record. (MBR – Master Batch Record).