制药业生产系统验证 - EBR/MES 系统验证
System validation in the pharmaceutical industry is a crucial process to ensure that computerized systems are fit for their intended use and meet current regulatory requirements. This is a mandatory requirement of cGMP (current Good Manufacturing Practices) and is essential for managing the quality of manufactured products. Any computerized system that could affect Patient Safety, […]
Accevo 为斯科普里制药公司 ALKALOID AD 实施 MES 和 MBR & EBR 解决方案
Accevo , a leading provider of production optimisation solutions, has entered into an agreement with ALKALOID, a leading pharmaceutical company in North Macedonia, to implement MES (Manufacturing Execution System) with EBR (Electronic Batch Record) solutions. These innovative systems, collectively known as AlkaMES, aim to enhance the production process, improve efficiency, and ensure compliance in the […]
电子批处理记录--制药业的自动化和纸张消除
It’s no secret that every step of the pharmaceutical manufacturing process must be documented. However, managing paper documentation can be extremely time-consuming for pharmaceutical manufacturers, and human error can be relatively common. For this reason, pharmaceutical companies decided to implement what is known as Electronic Batch Record (EBR) in order to both streamline workflow and […]