Definition
Revalidation is the process of confirming again that a validated process, system or solution still meets defined requirements after changes, the passage of time or other circumstances that may affect compliance.
Human Explanation
It asks whether a previously validated solution still meets its requirements.
Why it Matters
A significant change can affect a previously confirmed state of compliance.
Conceptual Boundary
Revalidation does not always require repeating the complete validation; its scope should follow a risk assessment.
Practical Perspective
It may be triggered by technical, organisational or regulatory changes or by significant deviations.