Berkshire Sterile Enhances Data Integrity with New Data Management System
Summary
Recently, Berkshire Sterile Manufacturing (BSM), a Massachusetts based fill finish CDMO producing clinical and commercial drug product, has instituted a new initiative to acquire and preserve data derived from its analytical instruments within a software system compliant to Part 211 requirements. This software allows analytical results recorded on compatible Mettler Toledo instruments to be stored on a 21 CFR Part II compliant database. BSM will implement the software across all compatible devices, ensuring a unified and efficient data management process across instruments in formulation suites, cleanrooms, and analytical labs that are consistently used for GMP activities. The system will also automatically synchronize the instruments’ clock, eliminating laborious manual updates, enhancing accuracy, and reducing the work load on BSM’s team. "This software not only enhances our ability to maintain high quality standards and compliance but also streamlines our processes, allowing us to better serve our clients."