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ROI CalculatorElectronic Batch Record (EBR) is the digital version of a batch record used to capture, review, and approve manufacturing data in real time.
FDA 21 CFR 211.188 requires complete batch production and control records. When managed electronically, systems must also comply with 21 CFR Part 11 for electronic records and electronic signatures. ISO 13485 and ISO 9001 require records to be controlled, traceable, and protected from unauthorized changes.
Why it matters: EBR reduces errors, improves traceability, and strengthens audit readiness.
