Definition
Qualification is the documented process of confirming that equipment, infrastructure or a system is correctly installed, operates as required and is ready for intended use or further Validation.
Human Explanation
It confirms that the environment and resources are prepared for safe and correct operation.
Why it Matters
Validation cannot be relied upon when the environment supporting the solution has not been adequately qualified.
Conceptual Boundary
Qualification concerns readiness and controlled operation of supporting assets, not the final confirmation of intended use for the complete solution.
Practical Perspective
Depending on context, Qualification may cover equipment, facilities, utilities, software and supporting processes.