What is an Electronic Batch Record?
Pharmaceutical companies are required to maintain batch records so that authorities can confirm proper procedures are being followed. Modern Electronic Batch Records (EBR) can help with this and help companies comply with FDA regulations. An electronic batch record uses several databases that record data that is recorded during the production of a batch. In addition, it uses a business process engine that defines the process to be followed.
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Pharmaceutical companies are constantly trying to manufacture in accordance with FDA regulations. The pharmaceutical industry has long been subject to strict regulations. Few other industries have to deal with such high levels of control, traceability and transparency. These regulations are necessary to maintain trade and ensure patient safety. Part of these regulations is that pharmaceutical companies are required to keep batch records so that authorities can confirm that proper procedures are being followed. For many companies, maintaining batch records is a challenging and time-consuming manual process because many organizations use batch records on paper. A modern Electronic Batch Record (EBR) can support this process and help companies comply with FDA regulations. These systems are also able to integrate with other business systems, such as an ERP.
Why is an Electronic Batch Record (EBR) so important?
An Electronic Batch Record (EBR) uses several databases that record data that is recorded during the production of a batch. In addition, it uses a business process engine that defines the process to be followed. The user interface shows the necessary sequence of tasks and instructions to the operators. In this way, pharmaceutical companies can monitor activities and record the appropriate results. The electronic batch records can be continuously updated and this automated recording of data reduces the risks and errors associated with a manually maintained batch record.
Would you like to know more about EBRs? Watch this video about MES and Electronic Batch Records (EBR)!
What is a Master Batch Record?
In addition to the Electronic Batch Record, pharmaceutical companies are required to maintain Master Batch Records (MBR) to comply with FDA regulations. MBR are general manufacturing instructions. Each batch must have its own MBR and contain general information about the batch such as: product name identification, bill of materials, equipment list, components list, etc. Essentially, the purpose of an MBR is to ensure that all necessary ingredients are added and that every step of the entire procedure is followed.
Manufacturing Execution Systems (MES) Electronic Batch Records (EBR)
Manufacturing Execution Systems (MES) enable pharmaceutical companies to improve their manufacturing processes and reduce their operating costs. In addition, MES also enables companies to better comply with legal requirements. The system connects all individual departments that contribute to the manufacturing process. The alignment of these different departments/functions provides visibility to key stakeholders and increases the overall performance of the organization. MES eliminates the use of paper batch records and turns them into Electronic Batch Records (EBR) and facilitates data integrity (data reliability).
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