The ValProbe family of temperature loggers is designed for accurate, convenient and reliable process measurement for pharmaceutical and medical device applications. The wireless design greatly simplifies monitoring and validation of serve and hard-to-reach environments. Probes are available in rigid and bendable version.

• RTD technology delivers unrivaled measurement accuracy over a wide operating range
• System downloads up to 10 probes simultaneously
• Easily defined cycle-based data collection, calculation, and reporting from up to 200 sensors
• Enables compliance with FDA Regulation 21 CFR Part 11
• Designed for easy on-site calibration
• Battery life indicator and field replaceable battery.
• Reporting capability to merge with a Validator study or a RF ValProbe study

• Sterilizers
• Ovens
• Tunnels
• Lyophilizers
• Stability chambers
• Warehouses
• Temperature chambers

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The Installation Qualification/Operational Qualification Protocol defines a set of procedures to ensure that our equipment is properly installed and operated according to Kaye recommendations, and adequately documented and controlled according to cGMP requirements. The documents are provided in hard copy and on CD, allowing users to modify the documentation to suit specific organizational requirements.

The IQ/OQ Protocol includes the following:

• Installation Qualification Document
• Operational Qualification Document
• Standard Operating Procedures Document
• Set Up Programs

IQ/OQ Services :

We can perform the IQ/OQ at a customer site or at our facility (Validator AVS, ValProbe RT and RF ValProbe II). Customers can also purchase the documentation and perform the IQ/OQ themselves.

• Save time and money by having our experts perform the IQ/OQ

Validation Reference

The Kaye Validator and ValProbe systems are supported with documentation that verifies a fully validated system, including software, hardware and firmware. The Validation Reference provides a comprehensive overview of the Quality Policy, description of ISO 9001 implementation and support procedures, and standards for the development, testing, and maintenance of hardware and software. Quality Control Documents, Development Procedures, Quality Assurance Procedures, Release Documents, and Quality Assurance Test Documentation are all included.
The Validation Reference is a serialized document, thus insuring registered users automatically receive notification and updates to maintain documentation current. The result is a summary of information you would obtain by conducting an audit at our facility; complete, well organized, neatly packaged and immediately accessible.

The Validation Reference includes the following:

• Quality Control Documents
• Development Procedures
• Quality Assurance Procedures
• Release Documents
• Quality Assurance Test Documentation

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Chinese