Change Control

Posted on January 09, 2013

In our last post, we talked about the importance of keeping business operations current with FDA regulations, and how this has to be constantly monitored in order to prevent gaps between the two. What we didn't cover is the way in which changes need to be made. The process is referred to as change control, and proper execution is of vital importance. Keep in mind that this discussion pertains to validated systems; any system that should be validated and has not been validated cannot be considered compliant.

Change control consists of the methods by which proposed system changes are researched, tested, executed, and documented. By properly performing a change control to a validated system, you are showing that whatever you are doing differently works in conjunction with what was previously validated. Boiled down, a change control is really just a mini-validation. The difference is the scale of effort, which makes a huge difference in the cost; quite a few...