What is included in a qualification?

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Each qualification comprises
• Writing the qualification plan
• Approving the plan
• Testing
• Writing the qualification report based on the testing
• Approving the report

What is included in the qualification plan?

The qualification plan shall include:
• Text to explain what the qualification plan comprises
• Error handling if this has not been described in the overall validation plan
• Acceptance criteria
• Test plan explanation if desired
• Test plans