Definition
Risk-Based Validation is an approach in which the scope, depth and intensity of Validation are proportionate to the Risk associated with the solution and its intended use.
Human Explanation
Higher Risk requires stronger Evidence and more rigorous control; lower Risk may justify a lighter but still adequate approach.
Why it Matters
It directs limited resources toward the functions, failures and outcomes with the greatest significance.
Conceptual Boundary
Risk-based does not mean optional Validation or reduced standards without justification. The assessment and resulting decisions must be documented.
Practical Perspective
Risk should be assessed before planning, revisited when conditions change and connected explicitly to Validation activities.