Using PILOT:EBR for the Electronic Batch Record Management, pharmaceutical companies take a great step towards full digitization of their production. PILOT:EBR provides a complete electronic and GMP-compliant process from formula generation to weighing and validation of production data up to the comprehensive documentation including batch logs. All regulatory rules and requirements, such as FDA, EMA, AMG, cGxP, etc. are integrated.
The Master Batch Record (MBR) is the basis of all manufacturing instructions integrating the generation and management of formulas according to the ISA-95/ISA-88 standards. This includes, for example, the definition of workflows, general conditions, equipment and quality requirements. This information is then used for all following operative processes like weighing, dosing, validation of production data and collection of further data. PILOT:EBR documents all manufacturing steps based on the MBR. One of the numerous benefits is the simple batch inspection and release. You can also integrate LIMS, building or process control systems and other systems via the relevant interfaces.