Berkshire Sterile Manufacturing (BSM), a Massachusetts-based fill-finish contract development and manufacturing organization (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.

BSM will implement a Mettler Data Management System, LabX, to improve data integrity for GMP activities. This software allows analytical results recorded on compatible Mettler Toledo instruments to be stored on a 21 CFR Part II compliant database. The new system will allow for greater traceability, permanence, and management of GMP data produced at the company.

The new Mettler Data Management System networks Mettler Toledo scales and other instruments, including Karl Fishers to transfer generated data onto a single platform. Analytical results are stored in a single database with a comprehensive audit trail and individual traceability for each result to the user that produced the result. The new system eliminates the need for printouts and weight slips, helping to streamline operations and improving data integrity and permanence.

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 workload on BSM’s team.

“We are pleased to introduce the Mettler Data Management System to our operations,” said Steven Kinney, associate director of manufacturing operations, BSM. “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.”

The new system is currently being installed with full implementation and release for use by the end of 3Q23.