validation Plan

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.