ABSTRACT
We can —nd the FDA’s de—nition of validation in its “Glossary of Computerized System and Software Development Terminology.” There, validation is de—ned as: “Establishing documented evidence which provides a high degree of assurance that a speci—c process will consistently produce a product meeting its predetermined speci—cations and quality attributes.” And we can also look at the FDA’s guidance on validation, which states that the FDA considers software validation to be: “con—rmation by examination and provision of objective evidence that software speci—cations conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently ful—lled.” These de—nitions give us the keys to what is required in performing validation-it is necessary to de ne what the system purports to do, establish evidence that it is doing that, and then provide support that it will continue to do that in the future.
