Table 5.

Overview of the validation approach for the automated stores of the UZ KU Leuven Biobank.

Phase (duration @ UZ KU Leuven Biobank)	Content	Who
Installation qualification (3 years)	Installation by manufacturer and Site Acceptance Test	Manufacturer in presence of user
Operational qualification (1 year)	Intended use: – Develop System Qualification and Acceptance Test – Time to place/pick 1–1000 samples – Time to freeze 1–100 samples – Scan performance of frozen and non-frozen tubes – Stress test by placing/picking >3,000 tubes – Universal Power Supply test during operation	User
	Labware verification: – Determine maximum fill volume and impact on system
	Unintended use: – Create pick order for duplicate tube ID – Create pick order for tube absent from store – Insert labware with incorrect orientation
	Cooling: – Determine Temperature homogeneity – Emergency power test and impact on cooling operations – City water backup test and impact on cooling operations
	Alarm connection Test
Performance qualification (1 month)	Simulation of intended routine use of the equipment (2 week repeat of estimated sample submissions and requests)	User
Implementation	Routine operation, daily monitoring of PIR and PLR, use of SQAT before/after PM and planned interventions, SQAT after unplanned intervention	User

PIR, Pick Retry Ratio; PLR, Place Retry Ratio; PM, Preventive maintenance; SQAT, System Qualification and Assessment Test.