Kaye VALIDATOR-2000 Thermal Validation System
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Kaye VALIDATOR-2000 is a standalone thermal validation system supporting FDA 21 CFR Part 11 compliance with secure electronic records, up to 36 sensor inputs, and independent reporting.
Product details
| Model | VALIDATOR-2000 |
| Manufacturer | Kaye |
| Category | Data Loggers |
| Availability | Made to order |
Description
Overview
The Kaye VALIDATOR-2000 is a benchmark thermal validation system specifically designed to enable compliance with FDA 21 CFR Part 11 regulations. All recorded data, including calibration offsets, setup parameters, and administrative tasks are saved in secure, encrypted, tamper-proof electronic records accessible only through the system software.
Key Features
- FDA 21 CFR Part 11 compliant secure electronic records
- Accepts up to 36 inputs in any combination of thermocouple, voltage, or current inputs
- Plug-in sensor modules to minimize handling and save calibration time
- Stores calibration offsets linked to specific instruments
- User ID and password protection for critical operations
- USB drive for setup loading, data storage, and firmware upgrades
- Flexible operation—standalone or with PC during testing
- Secure results with tamper-proof file format
- Comprehensive audit trail of all actions affecting data
- Internal memory with battery backup for data protection
- Sensor grouping capability (up to 4 groups)
- Independent Report Wizard for flexible reporting
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
Specifications
| Input Capacity | Up to 36 inputs (thermocouples, voltage, or current) |
| Data Storage | Internal memory with battery backup |
| Connectivity | USB drive interface |
| Sensor Grouping | Up to 4 groups |
| Standards Compliance | FDA 21 CFR Part 11 |
| Security Features | Encrypted, tamper-proof electronic records |
| Operation Mode | Standalone or with PC |
| Reporting | Independent Report Wizard |
| Data Protection | Comprehensive audit trail |
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Kaye VALIDATOR-2000 Thermal Validation System
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