Validation Plans (VP)

Validation Plans define the scope and goals of a validation project. The Validation Plan is written at the start of the validation project (sometimes concurrently with the user requirement specification) and is usually specific to a single validation project.

The collection of documents produced during a validation project is called a Validation Package. Once the validation project is complete, all documents in the validation package should be stored according to your site document control procedures.

Validation Plans are different than Validation Master Plans. Validation Plans are usually project specific; Validation Master Plans govern validation activities for an entire organization or site. Sometimes plans are also named for the applicable subject area, such as a Software Validation Plan.

Validation Plan Examples

A Validation Plan should include:

• Deliverables (documents) to be generated during the validation process
• Resources, departments, and personnel to participate in the validation project
• Time-lines for completing the validation project
• Acceptance criteria to confirm that the system meets defined requirements
• Compliance requirements for the system, including how the system will meet these requirements

The plan should be written with an amount of detail that reflects system complexity.

The plans should be approved, at a minimum, by the System Owner and Quality Assurance. Once approved, the plan should be retained according to your site document control procedures.

Frequently Asked Questions about Validation Plans

Q: What is the definition of Validation Plan?
A: The FDA uses the NIST definition: A management document describing the approach taken for a project. The plan typically describes work to be done, resources required, methods to be used, configuration management and quality assurance procedures to be followed, schedules to be met, project organization, etc. Project in this context is a generic term. Some projects may also need integration plans, security plans, test plans, quality assurance plans, etc. (See: documentation plan, software development plan, test plan, software engineering.) In practice, the validation plan describes how the validation project is going to be performed.

Q: Can I see an example of a validation plan?
A: We have a sample validation plan available for download.

Alternative Document Names and Acronyms

The following terms or abbreviations are sometimes used: Validation Plan, VP.

Validation Document Resources

• Validation Master Plans (VMP)
• Validation Plans (VP)
• Risk Assessment (RA)
• User Requirement Specifications (User Specs, URS)
• Functional Requirements (Functional Requirement Specifications, Functional Specs, FRS, FS)
• Design Specification (DS)
• Test Plan / Test Protocol
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Requirements Traceability Matrix (Trace Matrix, RTM, TM)
• Protocol Test Deviations
• Validation Summary Report (Validation Report, Summary Report, VR, SR)
• Change Control for Validated Systems
• Validation Terminology
• Validation FAQ (Frequently Asked Questions about Validation)

• Computer System Validation
• Part 11 Training
• Auditing and Assessments