Computer Validation Master Planning

The master plan should be developed early in the life cycle, with input from the targeted user community, the quality unit (regulatory/compliance), and the information technology group responsible for the system (development and support personnel). If the personnel that will maintain the system in production are different than the personnel responsible for implementing it, the former should also be represented. Although not always closely involved in plan development, it is critical that the system owner or sponsor (management of the business area the system will support) understand what is documented in the plan and be an approval authority.