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Pharmaceutical companies have traditionally used paper (hard copy) to maintain production batch records (PBR), also called master production batch records (MPBR), for FDA-compliance purposes. With the advent of 21 CFR Part 11 in 1997, the FDA began to accept electronic batch records systems. Since then, more and more manufacturers have recognized the advantages of automating the processes involved in controlling batch records.
Under CGMP regulations found in 21 CFR Parts 210-211, the electronic batch record (EBR) must demonstrate the accomplishment of every significant step in the production, packing, and holding of each batch of a drug product. CGxP requires extensive EBR system documentation, including batch dates, identity of major equipment/lines used, components/materials used and their weights, in-process and laboratory control results, complete labeling control records, sampling, and identification of personnel supervising or checking each step.
MasterControl’s electronic batch records system contains all the tools you need to create your electronic batch record forms, meeting all the requirements of Part 11. Our experienced process consultants will lead you through project scoping, requirements gathering, implementation, testing, validation, and go-live activities to deliver a EBR software solution that truly meets your organization’s needs.
Benefits of MasterControl’s electronic batch records management system include:
Electronic batch records software, developed by MasterControl, performs data integrity checks, automates calculations, and enforces required actions such as the initiation of an unplanned deviation. Automated routing ensures that all steps are carried out in sequence and that no signatures are missing, ever.
MasterControl’s EBR software tracks all routing information and data entered into the electronic form, allowing the batch coordinator to follow the overall process, identify bottlenecks, and understand the sequence of events during processing.
Connected EBR System Processes:
MasterControl EBR software solutions are part of the MasterControl integrated suite, allowing connectivity with other applications that control different quality processes. For example, production data can be correlated to deviations, material nonconformances, and customer complaints. Through its robust analytics capability, MasterControl leverages all data collected by the system for use in continuous quality improvement.