|The validation consultant’s role could be to develop requirements documents and a compliance validation plan for the client. We’d also arrange for user training, coordinate the installation and testing of the system, and write a validation summary report when the testing is complete. It’s an extremely formalized process for “kicking the tires.”
Mikie McGinnes, QA Edge Inc.
I had an interesting email exchange with Mikie McGinnes this week (pictured with her dog Chloe). She has an IT-related job I didn’t even know existed. Mikie is a validation consultant. And she loves her job!
Sometimes when you work in IT, it’s tough to explain to outsiders what exactly it is that you do for a living. Well, Mikie’s the one you call when your company needs to figure out how to prove it’s being compliant.
We need to add a definition for compliance validation to WhatIs.com. Mikie said:
When regulated industries install or change any equipment that impacts the identity, strength, or quality of their products, their regulatory agency requires that the company collect documented evidence to show that the equipment or process is operating as intended, that it produces the expected results (or product), and that the equipment or process will continue to operate as intended in the future. This “collection of documented evidence” is the validation.