What does a Validation plan include?

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Validation of a complete large system is complex. The goal is to break the task into smaller, manageable pieces. This is what is describes in the validation plan.

This could be done by defining stages in the project, or use the DQ-IQ-OQ-PQ approach. For each of the defined stages, define the assumptions and input to the stage, what shall be done during the stage, and the expected output of the stage. A list of the topics needed to be covered in the system SOPs shall be included, either in a stage or separately. Ideally this should be done before the system implementation, or at least as early as possible in the project.