Which option best describes a Design Verification Plan and Report (DVP&R) in practice?

• A. A plan outlining project milestones and budget estimates.
• B. A summary of clinical trial designs.
• C. A record of manufacturing supplier audits.
• D. Documentation showing that each design output meets input specifications, with the plan defining methods and the report recording results.

Answer: (D)

A Design Verification Plan and Report is about proving that design outputs meet the defined requirements through planned verification activities and documented results. The plan specifies how verification will be done—the methods, acceptance criteria, and the environment or conditions under which the tests or analyses will occur. The report then records the results of those verification activities, showing, for each design output, whether it satisfies the corresponding input specifications. This creates clear traceability from what was required to what was delivered, supporting the claim that the product design is ready for the next stage.

The other options describe different things: a plan focused on milestones and budgets is project management, not verification; a summary of clinical trial designs relates to study planning, not design outputs and verification; and records of supplier audits pertain to supplier qualification, not demonstrating that design outputs meet specifications.