Validation planning (German translation: Validierungsplanung) clearly defines exactly how the the procedures for the validation of devices, systems or processes is to be carried out. The most important elements of the validation plan are defined and documented in a validation master plan (VMP; translation into German: Validierungsmasterplan) or equivalent documents. The validation master plan is a summarized document that should be concise, precise and clear.

The validation master plan contains at least the following information:

• Purpose of the validation activity;
• Organization chart of the validation activities;
• List of all facilities, systems, equipment and processes to be validated;
• Documentation form and form to be used for logs and reports;
• Planning and schedule of the tasks to be carried out;
• Change control (German translation: Änderungskontrolle);
• References to existing documents.

For large projects, it may be necessary to create draw up separate large validation plans.

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