Data generated in the drug product process remains subject to rigorous scrutiny by the Food and Drug Administration (FDA). In particular, data originating from laboratory or manufacturing instruments necessitates permanence, traceability, and effective management.
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.
BSM will implement a state-of-the-art 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 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.
The data platform
The new Mettler Data Management System seamlessly 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, streamlining 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
One of the standout features of the new system is its compatibility with a wide range of instruments. 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.
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
- Steven Kinney, Associate Director of Manufacturing Operations
“We are pleased to introduce the Mettler Data Management System to our operations,” said Steven Kinney, Associate Director of Manufacturing Operations. “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.”
BSM’s commitment to quality and continuous improvement has always been at the forefront of its operations. By implementing the new Mettler Data Management System, BSM remains steadfast in this commitment and continues to search for new technological advancements to remain forefront in the industry.
The new system is currently being installed with full implementation and release for use by the end of Q3 2023.