Validation is documented proof which provides a high degree of assurance that a system, process, equipment, manufacturing process, and/or medical device software will be properly installed, operated and processed, is robust, consistent, and delivers a result that meets the predefined qualifications and quality requirements. The purpose of validation is to ensure that the medical equipment meets all quality, efficacy and safety requirements defined for the final product, both in worst-case situations and during all stages of production, while adhering to a controlled and documented process.
To the article What is validation? Why should validation be done? Who is committed to performing validation? What are the types of validation?”
