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...Life science manufacturing leaning the batch record process problem with records operates in a highly lead times can be significantly improved by re regulated environment and significant effort is expended engineering manual review approval error compiling reviewing correction processes rft fact consume substantial amounts of designing itself operator supervisor dedicated reviewer time despite this long for documentation poor right first performance are very common addition there often small cottage industry built up around errors some companies have addressed these issues implementing an electronic ebr but manythecostandcomplexityinvolvedmakesthisoption unfeasible all not lost however source bsm s benchmarking report what we find norealownershipfordocumentaccuracy ineffective interim reviews that many document mature stable static levels over resource or both added several years to improve at formal qc qa accuracy become norm accepted check rarely work well no real ownership understan...