A reliable system for effective batch management and faster documentation
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.
Alwyn Jones explains how the transition to flexible paperless manufacturing can enable production of more individualised medicines and therapies, with assured data integrity and transparency at every phase of the manufacturing process.
Many reasons for paperless software solutionsPaperless manufacturing in the pharma industry offers several advantages when compared to traditional procedures. Enabling a more detailed recording of process data, conditions and results, it helps build error-resistant processes that are more robust and less prone to deviations. Digital production can also significantly reduce the time and effort associated with entering data, documentation complexity and, of course, overall paperwork. With Opcenter Execution Pharma, we offer a proven software solution for electronic master batch record management that expedites the design, execution, review and release of master batch records (MBR) and electronic batch records (eBR).
Your fast track to efficient electronic batch record managementPaperless document management is based on an electronic batch recording (eBR) process that can be flexibly adapted to different environments, ranging from highly automated bulk and active ingredient manufacture to highly manual filling and finishing operation. The Opcenter Execution Pharma software solution electronically compiles critical data and offers end-to-end functionality that can be used immediately, and help to integrate manual and automated operations.
An integrated solution for fast implementation
Opcenter Execution Pharma 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.
Ensuring quality through review by exception
Opcenter Execution Pharma 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, Opcenter Execution Pharma 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.
A flexible environment for a more agile process
Fully compliant with FDA and GMP regulations and prevalidated to meet all current standards for pharmaceutical manufacturing, Opcenter Execution Pharma 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, Opcenter Execution Pharma 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.
Our proven track record for paperless manufacturingOpcenter Execution Pharma supports the accurate and paperless management of large volumes of documents. The result is faster information exchange and retrieval, a reduced need for storage space, fewer human errors, good data integration, KPIs and advanced information queries - and many customers benefit from our paperless solutions already today.
Integrated solution for the MES and automation levelsThe pharmaceutical industry is constantly seeking new ways to improve its processes and procedures, counter increasing cost pressures, and comply with official requirements. In this whitepaper, we explain how an eBR (electronic batch record) solution can manage regulated processes entirely without paper.
Pharma 4.0: The new era of pharmaceutical manufacturing – paperless manufacturing as the new standard