Definition
The process of establishing objective evidence that a process consistently produces results meeting predetermined quality requirements.
Human Explanation
It asks whether the process consistently produces the right result.
Why it Matters
A correctly designed process does not by itself guarantee stable results; Validation demonstrates repeatable performance.
Conceptual Boundary
Process Validation concerns the behaviour of the complete process, not acceptance of one product or one batch.
Practical Perspective
It connects planning, execution of studies, evaluation of Evidence and continued monitoring after implementation.