What is an Electronic Batch Record?
Pharmaceutical companies are required to keep batch records in order for authorities to confirm that the appropriate procedures are followed. Modern Electronic Batch Records (EBR) can assist in this process and help companies to comply with FDA compliances. An electronic batch record uses various databases that capture data that is recorded during the manufacturing of a batch. Moreover, it uses a business process engine that defines the process to be followed.
Manufacturing Execution Systems (MES) and Electronic Batch Records (EBR)
Manufacturing Execution Systems (MES) enable pharmaceutical companies to improve their manufacturing processes and reduce operational costs. Besides that, MES also enables companies to increase their compliance with regulatory 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 overall performance of the organization. The MES eliminates the use of paper batch records and change them in Electronic Batch Records (EBR) and facilitates data integrity (the reliability of data).