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neb2 replied to the topic Discussion Topic: Verification vs. Validation in the forum The Design History File 8 years, 2 months ago
Design verification tests whether each design output meets design input requirements. Therefore, individual design verification test aims to prove that each design output complies with each specification created from the DID. Design validation tests if the design conforms to user needs and intended use under specific operating conditions and risk analysis.
Process validation establishes by objective evidence that a process consistently produces a result or product meeting its predetermined specifications, therefore at the end the outcome should be the same. This involves a series of activities taking place over the lifecycle of the product and process. Process verification must demonstrate that the end product conforms to the requirements and the result are fully verified. If the result of a process cannot be fully verified, the process must be validated.