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 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.