Validation Master Plan (VMP)

Definition

A Validation Master Plan is a high-level, site- or organization-wide document that outlines the overall strategy, scope, and approach for validating systems, equipment, and processes, including EBR and other computerized systems, across the facility. It provides the governing framework that individual validation projects are executed under.

Benefits

A well-maintained VMP gives regulators and internal stakeholders a clear, organized view of an organization's overall validation strategy and status, rather than requiring them to piece together validation approaches and coverage from a collection of disconnected individual project documents.

Use Case

During an inspection, a regulator requests an overview of the site's approach to computerized system validation. The quality team presents the Validation Master Plan, which clearly documents the site's risk-based validation strategy and references the specific validation packages for systems including the EBR.

Frequently Asked Questions (FAQ)

Related Terms

• System Validation Lifecycle
• Computer System Validation (CSV) / CSA