Definition
An approved document defining the scope, methods, responsibilities, acceptance criteria and execution of specified Validation activities.
Human Explanation
It describes how the Validation will be performed and evaluated.
Why it Matters
An approved protocol creates a consistent basis for execution and later assessment of the Evidence.
Conceptual Boundary
A protocol defines planned work; it does not report the results obtained.
Practical Perspective
It should be reviewed and approved before execution, with departures handled as controlled Deviations.