Kaye reveals new-generation thermal validation system

Kaye Instruments of Germany has introduced its Validator 2000, astand-alone thermal validation solution. It is specifically designed to conform to new US Food and Drug Administration data protection guidelines and European EN requirements for pharmaceutical, biotechnology and medical device manufacturing plants.

Kaye points out that the new FDA regulations (21 CFR Part 11) have mandated procedures to guarantee the integrity of electronic records. The Validator 2000, it adds, meets these requirements with software that prevents unauthorized access, creates secure files and provides protection to ensure that raw data are not modified.