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Electronic Batch Records Software System (EBR) to Automate 21 CFR Part 11 Compliant Electronic Batch Record (EBR) Processes in Pharmaceutical Enviornments to Meet FDA 21 CFR Part 211 CGMP Requirements
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 process of 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.