What are the three steps in the validation documentation process?

The validation documentation process is structured to ensure that all necessary steps are taken to confirm that a method or system meets its intended purpose. The phrase "Say It, Do It, Prove It" effectively encapsulates these steps.

The first step, "Say It," refers to the phase where the requirements, objectives, and specifications of the validation process are clearly defined and documented. This sets the groundwork for what needs to be validated and establishes the expectations for performance.

The second step, "Do It," involves the actual execution of the validation activities according to the defined plans. This includes carrying out the tests, collecting data, and implementing the procedures necessary to validate that the system or process operates as intended.

The third step, "Prove It," centers on analyzing the results obtained from the validation activities and documenting the findings. This step is crucial because it involves demonstrating that the method or system meets the defined criteria through objective evidence.

This comprehensive approach ensures that validation is not just a checklist activity but a systematic process that guarantees the reliability and accuracy of the method or system in question. The other options do not accurately reflect the same comprehensive and systematic approach that is emphasized in ensuring effective validation documentation.