Pharma CDMO 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. The transition to the new system will take place in the next few months and will allow for greater traceability, permanence, and management of GMP data produced at the company. 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 synchronise the instruments’ clock, eliminating laborious manual updates, enhancing accuracy, and reducing the workload on BSM’s team.