GE Sensing has now introduced the Thermal Validation System 'Kaye Validator'. It is a standalone thermal validation solution specifically designed to conform with FDA data protection guidelines (21 CFR Part 11) and meet international and European cGMP requirements for inspection of pharmaceutical, biotechnology and medical device (EN285, EN554) manufacturing.
The Kaye Validator simplifies the entire validation process by reducing set up time, minimizing sensor handling, automating sensor calibration, neatly organizing study data and generating regulatory required reports. It comes with a comprehensive 1-year warranty and is supported by fully validated hardware, software and firmware documentation.
The unique features of the Kaye Validator are its flexibility to operate standalone or with PC during testing. It accepts up to 36 inputs in any combination of thermocouple, voltage or current inputs. It minimizes sensor handling and saves calibration time with plug-in sensor modules. It stores calibration offsets, allowing the software to link module with a specific instrument and prevents unauthorized access via user ID and password for critical operations.
Further, the product creates secure results using files that cannot be used if tampered with. It can create printed or spreadsheet reports from a single protected file and comprehensive audit trail of all actions affecting user data. It protects data with internal memory if floppy disk fills up or printer runs out of paper. It can save data with battery back-up and separates sensors in up to four groups.