ABSTRACT
Specifically for large and middle size complex systems, a validation project plan, also known as a CSV Plan, is developed to formalize the CSV process. The CSV Plan is the center for the tracking the execution of a validation project. It is used throughout the life cycle of an implementation project and shall be kept up-to-date. The CSV Plan ensures that the tools are in place to guide and control multiple parallel development activities and assures proper communications and documentation. Validation plans should include a high-level project schedule which includes the identification of resources. One key consideration in the project schedule is to provide adequate time for system analysis and preparation of specifications. Validation plans and their associated schedules are living documents that should be reviewed periodically. Phase gate verification activities, which are performed during each event, may be a perfect place to review the project plan and schedule.
