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The entire process is recorded, from starting plant material to market, through a Master Batch Record to ensure consistency of the process and full traceability back to the starting biomass and cultivations. The modular system suite includes components for Production Planning and Scheduling, Master Batch Record Management, Electronic Batch Recording, Weighing and Dispensing, Material Flow Control and Tracking, Equipment Integration, Warehouse Management, Quality Management, and Performance Management based on KPI Analysis. A review of batch records from the last two years of production for the Cystic Fibrosis Indicator Sweat Test System showed that the company has not followed a Device Master Batch record. |
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