Performance Qualification (PQ) Protocol for LUNA-BX7™ Automated Cell Counter
 
1. The PQ protocol is used to verify:
• The performance of the LUNA-BX7™ Automated Cell Counter after Installation Qualification (IQ) and Operational Qualification (OQ).
• That the system operates as expected under simulated real-world conditions, ensuring compliance with product specifications.
• System performance at specified intervals or after specific events, such as relocation or software updates.

2. The PQ protocol is required by:
• Users who need to validate the performance of their cell counting instrument in accordance with quality management systems such as GMP, GLP, GCP, or ISO standards.
• Customers who require periodic requalification or verification after hardware repairs, software upgrades, or environmental changes.

* Note: Logos Biosystems does not guarantee that this PQ protocol meets governmental or regulatory requirements. The customer is responsible for ensuring compliance with applicable regulations.

3. The PQ protocol consists of:
• A bound, hard copy of the PQ test procedures to be executed by the Customer Representative (CR).
• Verification data sheets and other relevant documentation generated during the qualification process.

* Note: The CR is the individual appointed by the customer to perform this qualification procedure. The CR may be an employee of the customer, an instrument distributor, or a third-party consultant in compliance with the customer’s SOPs.

4. The PQ protocol includes the following:
• Pre-Operation Verification: Ensures calibration and readiness of the instrument before testing begins.
• Brightfield and Fluorescence Counting Verification: Validates counting accuracy across different slide settings and modes.
• User Training Verification: Confirms that users are properly trained to operate the instrument effectively.
• Data Reporting and Documentation: Requires all test results, observations, and deviations to be recorded and reviewed for final approval.

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