LUNA-II™ IQ/OQ Protocol


LUNA-II™ IQ/OQ Protocol

Product Description

1. This IQ/OQ protocol is used to verify:

• The installation and operation of a newly purchased or a previously installed instrument.
• Updates or upgrades that may affect the instrument’s performance.
• The operation of the instrument that requires regular operation qualifications.
• The requalification of a previously qualified instrument that has been reinstalled or moved to a new location.

2. This IQ/OQ protocol is required by:

• Users who need to validate quality management systems such as GMP, GLP, GCP, or ISO standards.
* Note: Logos Biosystems makes no representation or warranties of any kinds that this IQ/OQ protocol meets or will meet any mandatory requirements of any governmental organization or other entities in any country in the world. The customer acknowledges and agrees that the customer is responsible for meeting governmental regulations and certification requirements.
*Note: The software of the LUNA-II™ does NOT meet 21 CFR Part 11.

3. This IQ/OQ protocol consists of:

• 1 bound, hard copy of IQ/OQ test procedures performed by the Customer Representative (CR).
* Note: The CR is the person appointed by the customer who performs this qualification procedure. The CR may be an employee of the customer, the instrument distributor, or a third party consultant, according to the customer’s SOPs.
* Note: This protocol does NOT provide consumables necessary to perform the procedures.

4. This IQ/OQ protocol includes the following:

• Installation Qualification (IQ) Procedures
• Customer Representative (CR) Verification
• Environment Conditions Verification
• Instrument and Document Verification
• Installation and System Verification
• Operating System and Firmware Version Verification
• Operation Qualification (OQ) Procedures
• Pre-Operation Verification
• Counting Verification
• Data Saving and Reporting Verification
• Warranty Verification
• User Training Verification

This product is for research use only. Please consult the material safety data sheet for information regarding hazards and safe handling practices.
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