Validating Equivalent Lab Systems

GOOD VALIDATION PRACTICE (cGVP) EQUIPMENT VALIDATION
1

Scenario: A GLP department has 10 Agilent HPLCs, all running the same software but slightly different versions and firmware. The 10 HPLCs plan on having 1 Validation Plan and 1 Requirement Specification.

We want to develop a testing Approach that performs a full blown IQ/OQ/PQ/UAT on one system (MASTER). Then perform a full blown IQ and an abbreviated OQ/PQ/UAT on the remaining 9 systems. We’re unsure whether to write up a Summary Report for each system or wait until all 10 HPLCs are tested.

The abbreviated OQ/PQ/UAT performed on each of the 9 systems would only test functions and add-ons not tested during the MASTER’s OQ/PQ/UAT.

Can or has this been done? (If so, can you explain the approach that you used.)

2

I would say that this could be done if all 10 of the HPLC’s were identical.

If you could prove that all of them are like for like then, then yes I dont see any problem in running a partial IQ/OQ verfication, but in this case you have said that some of the HPLC’s are running different versions of the software and different versions of the firmware. In this case I would push for a full IQ/OQ on each as you cant guarentee that each HPLC will function the same.

If each HPLC was identical then I would go for a combined summary report but in this instance I would generate a unique summary report for each as they are all slightly different.