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EBR Software Systems - Electronic Batch Records

EBR Software Systems - Electronic Batch Records

EBR Software Systems - Electronic Batch Records Automate EBR Systems with MasterControl Electronic Batch Records Software Systems to Ensure Compliance with FDA CGMP Requirements For pharmaceutical companies, accountability is an important component of quality management and FDA compliance. Electronic batch records systems, required by FDA Current Good Manufacturing Practice (CGMP) regulations, demonstrate accountability by providing proof of proper handling for every step in the production of each batch of a drug product. In addition, manufacturers that execute and document batch records electronically must comply with 21 CFR Part 11 requirements.

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