LUNA-FX7™ PQ Protocol
LUNA-FX7™ PQ Protocol
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LUNA-FX7™ PQ Protocol
Product Description
1. The PQ protocol is used to verify:
• The performance of the LUNA-FX7™ 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.
This product is for research use only. Please consult the material safety data sheet for information regarding hazards and safe handling practices.
Additional information is available on our website atwww.logosbio.com
Description
LUNA-FX7™ PQ Protocol
Product Description
1. The PQ protocol is used to verify:
• The performance of the LUNA-FX7™ 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.
This product is for research use only. Please consult the material safety data sheet for information regarding hazards and safe handling practices.
Additional information is available on our website atwww.logosbio.com