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Process model

Validation Lifecycle

A model describing the planning, execution, maintenance and periodic review of Validation throughout the operating life of a solution.

Related domain: ValidationConcept ID: concept-validation-lifecycle

Definition

The Validation Lifecycle describes planning, execution, maintenance and periodic review of Validation throughout the operating life of a solution.

Human Explanation

Validation continues after initial approval because the solution, its use and its environment can change.

Why it Matters

Lifecycle control keeps the validated state aligned with current Requirements and Risk.

Conceptual Boundary

The lifecycle is broader than testing or acceptance and includes change, review, maintenance and retirement considerations.

Practical Perspective

Review points, change triggers, responsibilities and conditions for revalidation should be defined in advance.

Related Concepts