When building a house, the first thing you must do is create a blueprint. A Validation Master Plan (VMP) is a blueprint for the validation of your software.

The Framework

The VMP provides the framework for how validation is performed and documented, how issues are managed, how to assess validation impact for changes, and how to maintain systems in a validated state.

The VMP should cover such topics such as:

• • The scope of the validation
  • The approach for determining what is validated, unless this is covered in a separate corporate plan, for example, a quality plan
  • Elements to be validated, and how to maintain the list
  • Inter-relationships between systems
  • Validation responsibilities; Periodic reviews
  • Re-validation approaches
  • The rationale for not validating certain aspects of a system, so you don’t have to revisit your decision during audits
  • The approach to validating those applications if your company has applications that have been in production but have not been validated (retrospective vs prospective)
  • The validation approach to validate a system that is already commissioned and live, but not formally validated
  • And general time lines, milestones, deliverables and roles and responsibilities of resources assigned to the validation project

Static

The majority of the VMP is static. To avoid re-releasing the entire document, maintain specific elements to be validated and the top-level schedule in separate, controlled documents.