Assigning risk should be a multi-disciplinary function.
System owners, key end-users, system developers, information technology, engineers, and Quality should all participate if they are involved with the system.
In validation, Risk Assessment documents potential business and compliance risks associated with a system and the strategies that will be used to mitagate those risks.
Risk Assessments justify allocation of validation resources and can streamline the testing process.
The VP must specify methodologies, assign staff, designate responsibilities and give specific guidance on any contentious or ambiguous aspects of the VP validation task.