IQ/OQ Protocols

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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