Kaye Validator Benchmark Thermal Validation System Highlights

The Kaye Validator is specifically designed to enable compliance with FDA 21 CFR Part 11. All recorded data, including calibration offsets, set-up parameters, and administrative tasks are saved in secure, encrypted, tamper-proof electronic records in a format accessible only through the system software.

• USB drive to load setups, store study data, upgrade firmware
• Independent Report Wizard – Common reporting software for Validator® RF ValProbe® and ValProbe®
• No more hassle with floppies
• Offers flexibility to operate standalone or with PC during testing
• Accepts up to 36 inputs in any combination of thermocouple, voltage or current inputs
• Minimizes sensor handling and saves calibration time with plug-in sensor modules
• Stores calibration offsets, allowing the software to link module with a specific instrument
• 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
• Protects data with internal memory
• Documents exceptions easily
• Saves data with battery back-up
• Separates sensors in up to four groups

Applications

• Steam Sterilizer (Autoclave) validation
• Dry heat sterilizer validation
• Steam in place (SIP) validation
• Water cascade/fall sterilizer validation
• Incubator validation
• Stability Chamber validation
• Freezer validation
• Freeze dryer / Lyophilisation validation
• Vessel validation

A Complete Kaye Validator Benchmark Thermal Validation System Includes Other Optional Items:

• Kaye Validator
• Dry Well
• IRTD reference probe
• Up to 3 SIMs calibrated
• 200 ft Thermocouples
• NIST Calibrated
• GAMP5 validated according to 21CFR Part 11.
• Laptop
• Software