Post-Validation Change Control and Maintaing the Validated State

"You need to be able to control changes just as much, with as much discipline and robustness as you did the original validation," Joe Zec says during a presentation from IVT's 11th Annual Change Control. Quoting FDA's General Principles of Software Validation and Process Validation Guidance, Zec enforces the regulators' perspective on change control for a process already in the validated state. "[I]f you're going to maintain this validated state of a process, or a piece of software, or an equipment full change control must remain in effect until retirement..." Through impact analysis, Zec explained, is how a change control process will ensure all applicable elements of a system will update. On behalf of every change, professionals will need to decide whether software and data, hardware, system documentation, user documentation, training, or procedural documentation is affected. "After a system is in a validated state, if any of these elements are allowed to go into an unvalidated state, the whole system goes into an unvalidated state. You need to keep every single one in a validated state via maintenance through change control."