Paperless production in the pharmaceutical industry
Along with challenges such as cost pressures and tough competition, the pharmaceutical industry also faces very specific obstacles. These include the requirement for manual documentation and review of all production processes, which is stipulated by the regulatory authorities. A new paperless manufacturing solution can simplify documentation and reviews while also making them more efficient. The new solution from Siemens can play a major role here: paperless pharmaceutical production greatly reduces documentation work without violating the strict requirements of the regulatory authorities. Paperless manufacturing facilitates consistent communication between the automation level and production IT. SIMATIC IT eBR is a software solution for electronic master batch record management. It enables integration between the manufacturing execution system (MES) and process control system (DCS) using SIMATIC PCS 7 and SIMATIC BATCH. In doing so, SIMATIC IT eBR speeds up the creation, execution, review and release of pharmaceutical manufacturing processes and batch protocols.
Batch record management with SIMATIC IT eBR
SIMATIC IT eBR is a software solution from Siemens for electronic master batch record management. It enables native integration between the manufacturing execution system (MES) and process control system (DCS) using SIMATIC PCS 7 and SIMATIC BATCH. The fully automatic formula processes are as central to the solution as are support and tracking of manually operated production steps. Quality-related production data can thus be collected and documented fully electronically – without the previously large amount of manual procedures and batch protocols in paper form. An eBR (electronic batch record) system for paperless production should cover three steps: design, execution and review.
Integrated solution for fast implementation
Our software solution offers electronic master batch record management based on the native integration of MES (manufacturing execution system) into SIMATIC IT eBR and the process control system into SIMATIC PCS 7 and SIMATIC Batch. The seamless integration of batch processing into the process control system and workflow management into the MES system simplifies and speeds up the implementation of a paperless process documentation solution. The time it normally takes to implement a formula, one year, is thus shortened to only two months. To simplify the review and release process and reduce the amount of quality assurance work, only queried batches have to be reviewed (review by exception).
Quality through review by exception
Paperless manufacturing ensures efficient quality assurance. Every step and every raw 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 at run-time (review by exception), which significantly speeds up the release.
Benefits at a glance
Paperless manufacturing gives companies of varying size an automated MBR/eBR process that can be flexibly adapted to different environments – from drug production with largely manual workflows to the production of active ingredients with highly automated processes. SIMATIC IT eBR makes paperless manufacturing in the pharmaceutical industry a reality. The solution collects critical data electronically and provides comprehensive functionalities that can be used immediately, including:
Electronic collection and documentation of all production data
Concurrent release on the basis of deviations (review by exception)
Integration that combines automation with production IT (ERP level)
Reduced implementation effort and risks