Course Code: ELM-111-04

Your Guide to Software Validation PQ’s [Video]

Performance Qualification, often abbreviated to PQ, is the set of tests that verifies the system for perform correctly under conditions representing normal use.

Least Understood

The PQ is likely the least understood protocol in a validation exercise. The genesis of the PQ is manufacturing systems validation where PQ shows the ability of the equipment to sustain operations over an extended period, usually several shifts. Those concepts don’t directly translate well for many software applications.

Web Based Applications

However, there are good cases where a PQ can be used to more fully validate. Web-based applications, for example, may need to be evaluated for connectivity (i.e., what happens if a large number of users hit the server at once).

Database Applications

Another example is a database application. Performance can be shown for simultaneous access and for what happens when the database begins to get large. PQ is the place where, as applicable, confirmation is made that the system properly handles stress conditions applicable to the intended use of the equipment.

Validation Plan

There may even be cases where operators can, through marginally different use of the system, can influence the outcome. Critical thinking about what could impact performance is key to developing a PQ strategy.

It may well be the case that a PQ is not applicable for the application. The decision and rationale is documented in the Validation Plan.

Author

Don Hurd

Practical Quality & Thorough Validation The Realtime Group