Validation Plans define the scope and goals of a validation project. Validation plans are written before a validation project and are specific to a single validation project. Validation Plans can include:
- Deliverables (Documents) to be generated during the validation process
- Resources/Departments/Personnel to participate in the validation project
- Time-Line for completing the validation project
Validation Master Plans discuss validation activities across an entire site. Validation Master Plans can outline documents required in validation project and general goals or strategies for all validation projects. Having a validation master plan may dictate that validation plans are not necessary for each validation project.
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Validation Plans should be approved by the System Owner and Quality Assurance. Validation Master Plans should be approved by the Head of Site Quality, plus other department heads as appropriate.
The collection of documents produced during a validation project is called a Validation Package. Once the validation project is complete, all validation package should be stored according to your site document rules.
Acronyms
Validation Master Plans, Validation Plans, VMP, VP
Additional Resources
Validation Document Resources
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