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The Fundamentals of Validation Planning

A Validation Master Plan (VMP) is a comprehensive description of the validation process that states the scope of the project, the tests that will be performed, the schedule of activities, and the validation tasks that need to be accomplished. The plan also indicates who is responsible for document preparation, test scipt development, test script execution, review and approval, etc.  

Why do Life Science Organizations need a Validation Plan?

Validation is the compilation and evaluation of data from design through production, demonstrating evidence of an executed process. The process validation cycle consists of creating a Validation Master Plan (VMP) to guide a successful validation process.

The Validation Plan is a roadmap for qualification. It not only documents evidence of the current system state but also defines system risks, boundaries, functional scope, and intent of the system. A competent validation process maintains quality assurance that a software system is working to its intended uses.

Validation Maser Plan (VMP) Purpose

The Validation Plan is a resourceful guide that identifies resources, schedules project timelines, and documents the Scope, including affected products, procedures, facilities, utilities, and equipment. The Validation Plan is beneficial as a process control tool that instructs how and why a validation process is executed. Fundamentally, it serves as a compliance tool to document the validation procedure required by regulatory agencies like the FDA, MHRA, and EMA.

The Validation Plan enables organization stakeholders to harmonize the validation strategy details so that validation activities are justified internally for teams and externally for third-party audits. It has the advantage of informing others in an organization not familiar with compliance about the importance of validation concerning its effect on product quality.

Arbour Group’s Validation Plan comprises the following: 

  • Business Scope & Objective: A reference to the business process that consists of company background, objective, and business scope.
  • System Scope & Objective: The system boundaries in which testing will occur. 
  • Platform & Application Components: The platform infrastructure, I.e., hardware and software support the application. The application describes considerations and configurations that dictate required deliverables.  
  • Validation Approach & Deliverables: Describes the phases of validation with associated  deliverables and the relationship between deliverables. 
  • Go-Live and Validation Maintenance: The system management maintains a validated state after the Go-Live. 

The Arbour Advantage 

The Validation Master Plan is a vital resource when paired with Arbour Group’s industry knowledge and expertise that reduces the cost of compliance. Software testing meets compliance requirements, identifies risk factors, enhances productivity, and helps ensure project success. Contact us to discuss how we can raise quality levels while reducing costs.