Kaye Validator 2000
The Validator 2000 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 Validator 2000 simplifies the entire validation process by reducing setup time and minimizing sensor handling, automating sensor calibration, neatly organizing study data and generating regulatory required reports.
- Meets FDA guidelines for protecting electronic data (21 CFR Part 11)
- Prevents unauthorized access via user ID and password for critical operations
- Creates secure results using files that cannot be used if tampered with
- Creates printed or spreadsheet reports from a single protected file.
- Creates comprehensive audit trail of all actions affecting user data.