Mettler-Toledo Inc.

July 20, 2004
Innovations for Electronic Recordkeeping
To assist pharmaceutical companies in meeting FDA 21 CFR Part 11 requirements, Mettler-Toledo has developed two solutions that create electronic records, instead of printed documents with handwritten signatures. The 3.2 Quality Management System is said to offer pharmaceutical companies a more robust, one-source quality management solution for both packaged product and process control. It is designed to be used with the ID30 terminal, which has been developed using the latest software to solve the most demanding weigh applications problems.The platform can be used in various operations.  For example, in tablet production, it provides a simple and reliable way of checking tablet characteristics such as weight, diameter, thickness, hardness, friability and disintegration. On the packaging line, its manufacturer says, it monitors quality attributes such as expiration date, seal integrity, label position and net content control via random sampling.The two technologies can help users with the validation process, says Ken Falk, Mettler-Toledo industrial business area market manager. "Statistical quality-control systems used in the GMP environment must be legally validated," he asserts. "With ready-made validation protocols, time, money and labor are all significantly reduced."