Leaning the Batch Record Process
This briefing addresses the issues and problems often associated with manual Batch Records, including long review and approval lead-times and poor ‘first time’ document accuracy.
Life Science manufacturing operates in a highly regulated environment and significant effort is expended in compiling and reviewing batch records. In fact batch records consume substantial amounts of operator, supervisor and dedicated reviewer time. Despite this, long lead-times for approval fo the batch documentation and poor 'Right First Time' (RFT) performance is very common.