Paperless manufacturing with eBR solutions
A reliable system for effective batch and faster paperless document management
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 (eBR) 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.
Speed up records and reports
By enabling a more detailed recording of process data, conditions and results, paperless manufacturing 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).
Full compliance with FDA and GMP regulations
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.
Paperless document management is based on an electronic batch recording (eBR) process that can be flexibly adapted to different processes, ranging from highly automated bulk and active ingredient manufacture to highly manual filling and finishing operations. The MES Opcenter Execution Pharma software solution compiles critical data and offers end-to-end functionality that can be used immediately and help to integrate manual and automated operations.