A change control opened after the change is a deviation with a different form number

This is lesson 1.1 of the course exactly as enrolled learners see it, minus the video walkthrough and the practice record. Read it and you will know whether the course teaches the way you learn.

12 minAs seen by enrolled learners

In this lesson you will

State what change control is for in one sentence that an inspector would accept
Recognise the four ways a change gets made before it is controlled, and what each one costs
Apply the proposed-state test to decide whether a record is a change control or a retrospective deviation

Ask ten people on a site what change control is for and most will say something about paperwork, approval or QA. Ask an inspector and you get a different answer: change control is how a site proves that the validated state, the registered dossier and the quality agreements all survived the change. Everything else on the form is in service of that proof. When a record cannot show it, the change was uncontrolled whether or not a form exists.

What the record has to prove

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