Qualification Checklist

Refer to the qualification procedure Qualification Run.

The checklist is an optional tool available for use to ensure adherence to the procedure and should not be used exclusively to drive full compliance with procedural directives.

Account:
Location:
Country:
Contact title:	Contact Name:
Telephone:	Contact Email:
MAX Serial Number:	Software version:
Multimeter Serial Number:	Multimeter Expiration Date:
Caliper Serial Number:	Caliper Expiration Date:

 

Installation Qualification	Y	N	N/A
Are there any signs of damage to the instrument?
Are there any signs of damage to the peripherals?
Is the instrument level?
Is the instrument free from direct sunlight and ventilation?
Does the GUI screen appear when powering up the instrument?

Operational Qualification

Operational Qualification - Initialization	Y	N	N/A
Initialize motors.
Did you successfully home all motors? If No, please comment in Remarks section below.
Remarks:

 

Performance Qualification	Y	N	N/A
Check 24 Sample Test Runs.
Did you check the cartridge for fill issues?
Did you add all your Qualification results to your work order?
Please note Qualification Kit Lot number
Please note Cartridge Kit Lot number

 

All Requirements must be met. If N/A was selected for any of the above items, please justify why in the space below.

N/A Justification:

 

General Comments:

 

BD FS Signature and Date:	Customer Signature and Date
Signature:       Date:	Signature       Date: