About this case study Through the implementation of BatchLine EBR, the factory has seen a 60% reduction in data entry time and a 50% reduction in time required for quality reviewing and approval. The system assists the operators, supervisor and QA personnel to avoid mistakes or correct errors in a process almost immediately. Real-time data visibility also enables quality personnel to conduct a review by exception and achieve right-first-time production.
This article is the third part of a series based on applying the new GAMP GPG Data Integrity - Manufacturing Records Continuing our article on the GMP aspects of Electronic Batch Records (EBR) we look into a set of questions about controlling Master Recipe, Material Control, Equipment Control and Users Based on GAMP GPG Data Integrity Manufacturing Records Appendix 2, this is related to Manufacturing Execution Systems (MES) and so in some cases (Equipment Control) is not relevant for BatchLine EBR.
This article is the second part of a series based on applying the GAMP Good Practice Guide (GPG) Data Integrity - Manufacturing Records Continuing our article on the GMP aspects of Electronic Batch Records we look into the need and value of Risk Assessments; this appendix to the main GPG looks at threats to data integrity with data stored in a typical EBR. How to perform a Risk Assessment for EBR data? Our Questions & Answers... (Based on the GAMP GPG Data Integrity Manufacturing Records Appendix 2).
This article is the first part of a series based on applying the ISPE GAMP GPG Data Integrity - Manufacturing RecordsElectronic Batch Record (EBR) systems collect information about the process operation as the manufacturing progresses. Regulations require Batch Record data to be managed under the ALCOA+ principles, download the content below for a summary on how EBR ensures these principles and the typical improvement over paper record controls.