Truenat Instrument Installation Criteria

Compliance to equipment installation criteria is necessary to/for:

• Establish accurate and reliable results as claimed by the manufacturer
• To assure standard/specific requirements are met
• Provide proof that the process will consistently produce predetermined outcome
• Equipment safety
• Improve overall performance of the equipment
• Decrease work interruptions due to equipment failure
• Lower repair costs
• Cover equipment warranty and free maintenance 

Instrument Qualification Documents include:

1. Installation Qualification- IQ
2. Operational Qualification- OQ
3. Performance Qualification- PQ

Installation Qualification

IQ provides evidence for delivery, installation and configuration of the instrument as per manufacturer’s standards using an installation checklist.

Operational Qualification

OQ is a collection of test cases used to verify the proper functioning of a system before the instrument is released for use.

Performance Qualification

PQ is a collection of test cases used to verify that the system performs as expected under simulated real-world conditions.

Resources

• MolBio Diagnostics Pvt. Ltd.

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