Contains all validation activities with the respective documentation and planning. The validation master plan is subjected to regulatory inspection.
It is created by the user in order to define validation activities, responsibilities and procedures.
Some prerequisites include:
URS
Validation Policy
Tasks and Content
Preparation, review, and release of validation master plan
Roles and responsibilities
Organizational structure
GxP criticality assessment
Validation strategy
Validation deliverables
Acceptance criteria
Change control management
Standard operating procedures
Training
Documentation management
Maintenance of the validated state