validationsplan

A validationsplan, or validation plan, is a formal document that describes the overall approach, objectives, scope, and activities required to demonstrate that a product, process, or system meets predefined requirements. It is used in regulated industries such as pharmaceuticals, medical devices, biotechnology, and related fields, as well as in software development, where evidence of compliance and quality is essential.

The plan outlines why validation is necessary, what will be validated, and how success will be judged. It typically specifies the validation strategy, acceptance criteria, and the roles and responsibilities of project team members. It also describes the methods and testing that will be used, including qualification stages such as installation qualification, operational qualification, and performance qualification where applicable. Risk assessment and traceability to stated requirements are common elements, together with the documentation plan for records, protocols, and reports that the validation activities will generate.

Key components of a validationsplan include the scope and objectives, the validated items and boundaries, the validation approach and methodology, defined acceptance criteria, testing and inspection methods, the schedule and resource requirements, and the change control and revalidation criteria. It also identifies deliverables, approval workflows, and how results will be reviewed and archived to support regulatory compliance and quality assurance.

The validationsplan is typically part of a broader validation lifecycle, often linked to a master validation plan or site master validation plan. It is considered a living document, updated in response to changes in requirements, processes, equipment, or regulatory standards, and used to guide ongoing validation activities and audits.