Posts Tagged ‘by FELTEN solution’


Electronic Batch Records (EBR)

by yudaica2013 ·

Serrig makes all quality-relevant parameters of the manufacturing process electronic batch records (EBR) transparent, 04.06.2008 – not marketing a product (batch) without the associated batch record of a documentation of the production information – must be in strictly regulated industries such as the pharmaceutical industry. But in other sectors the batch protocols apply now often as the basis for a sound proof of product quality. Background is the need for maximum transparency, for example in the case of product defects in the manufacturing process causes faster can be determined and a simple tracking of the process chain is possible. Despite the high labour costs of batch records in the most manufacturing companies are still mainly manually. Necessary automation, as it is the PM of production intelligence system-SCADA offers MES by FELTEN. It meets the requirements for a paperless production on the basis of electronic batch records (EBR).

The System ensures the conformity according to 21 CFR part 11 for the treatment of electronic records and electronic signatures (ER/ES) and also ensures a reliable process data archiving. The electronic batch record (EBR) is an electronically generated manufacturing documentation and provides the user a summary analysis of all information of the manufacturing process with the entire quality relevant parameters as for example, batch or process data. Open the restore log, or further analyses of the production data can be visualized on a comfortable graphical user interface. Should the production according to the quota been run be, these variations in the production log are documented consistently. The meaningful representation of the results allows for a fast and efficient assessment for release in electronic form all departments. The industry package EWC von FELTEN also allows paper-based batch protocols with electronically generated batch records to a digital Batch totals to summarize. This can be generated throughout the process regardless of the document type (paper or electronic) or the individual batch record creators. The production management system of PM-SCADA MES takes over the coordination and documentation of the entire production process.

It controls the activities, the material and the data flow. In addition, it combines information from multiple systems in a knowledge base and provides a platform for flexible and transparent evaluation of the manufacturing process so the users. The MES acts as a central data store, which makes the memory”of the manufacturing process, which generated the electronic batch record as a result. About FELTEN GmbH: The FELTEN GmbH is an international operating software and consulting company, the solutions to optimise processes for all production areas and according to international quality standards of GMP and FDA (21CFR part 11) developed.