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ROI CalculatorBatch Records are the controlled records that document how a specific batch was manufactured and tested, step by step, with objective evidence. Under FDA CGMP, 21 CFR 211.188 requires batch production and control records for each batch, including an accurate copy of the master record, plus complete production and control information with dates and signatures.
They also need traceability for execution and exceptions. 21 CFR 211.100 requires written production procedures and deviations from those procedures are documented and justified. FDA also expects identification of the people performing, supervising, or checking significant steps.
If managed electronically (EBR), the records and e-signatures should align with 21 CFR Part 11 expectations.
