A VMP is going to start with a purpose, a scope, and a summary of the overall validation strategy.

These sections will explain which of the aforementioned approaches we are taking.

Validation Strategy

The validation strategy likely includes a definition of:

• The Life Cycle Approach to Validation (Concept, Project, Operation and Retirement)
• Defining Requirements
• Basing the Validation on a Risk Assessment
• Defining Hardware
• Defining Software
• Defined Project Inputs
• Defined Project Outputs
• Defined Acceptance Strategies

VMP Core

The core of the VMP will include the deliverables of the validation activities and a conclusion of the state of the systems validation and if it is fit for use.

In addition, the VMP may include information on:

• Security
• Support
• Business Continuity
• Disaster Recovery
• Change Management
• Revalidation Frequency and Requirements
• A Retirement Strategy
• A summation of Training and Supportive Documentation (such as equipment specific SOP’s)