Faced with growing cost pressures, regulatory and safety guidelines as well as increasingly diverse product portfolios, pharmaceutical manufacturers are continuously looking for ways to improve production processes. Our proven electronic batch record solution enables completely paperless manufacturing within regulated processes. It supports operational and manufacturing efficiency in both manual and highly automated environments - from the design of the batch record to the release of the batch report.
SIMATIC IT eBR includes a native integration between the manufacturing execution system (MES), the process control system (DCS) using SIMATIC PCS 7 and the HMI level with SIMATIC BATCH. The integration of batch processing based on the process control system with workflows and tasks that are managed in the MES system simplifies and speeds up the collection of data during operations. Integrated design means that the systems can be configured together directly. This helps cut the time it normally takes to implement a recipe drastically: in a typical project from one year to only two months.
SIMATIC IT eBR enhances MBR design flexibility by providing all the master information from SIMATIC BATCH to the MES design tool. It seamlessly integrates DCS batch processing with MES workflow management, thus streamlining and accelerating solution implementation for paperless manufacturing. Once in place, SIMATIC IT eBR expedites the design of master batch records (MBR) and the execution, review and release of electronic batch records (eBR). Every step and every material can be monitored, tracked and recorded during production. The systems coordinate the real-time control processes on each level, synchronize the process steps, and exchange parameter values. Reviews are conducted with the help of exception rules that identify and document deviations. The deviations can be processed during operations (review by exception), significantly speeding up the release.
Fully compliant with FDA and GMP regulations and prevalidated to meet all current standards for pharmaceutical manufacturing, SIMATIC IT eBR optimizes batch manufacturing processes and helps streamline resources, equipment allocation and standard operating procedures (SOPs). By simplifying the design, execution, review and release of master batch records and electronic batch records, SIMATIC IT eBR provides tremendous flexibility for accommodating product variety and diversity. The solution collects critical data electronically and provides comprehensive functionalities that can be used immediately, including electronic collection and documentation of all production data. This enables concurrent release based on deviations (review by exception), integration that combines automation with production IT (ERP level), leading to processes that are more agile as well as a reduced implementation effort and risks.
Pharma 4.0: The new era of pharmaceutical manufacturing – paperless manufacturing as the new standard
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