Validation is intended to check that a product, service, or system (or portion thereof, or set thereof) meets a set of design specifications and meets the operational needs of the user. In the pharmaceutical, medical device, food, blood establishments, tissue establishments, and clinical trials industries, validation is the documented act of demonstrating that a procedure, process, and activity will consistently lead to the expected results. It often includes the qualification of systems and equipment. It is a requirement for good manufacturing practices and other regulatory requirements. The design, production, and distribution of drugs are highly regulated. This includes software systems.
Reasons for validation
Validation is establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes. A properly designed system will provide a high degree of assurance that every step, process, and change has been properly evaluated before its implementation. Testing a sample of a final product is not considered sufficient evidence that every product within a batch meets the required specification. Procedures involve performing special tests to model or simulate a portion, or the entirety, of a product, service or system, then performing a review or analysis of the modeling results. Procedures also involve regularly repeating tests devised specifically to ensure that the product, service, or system continues to meet the initial design requirements, specifications, and regulations as time progresses.
A basis for qualifying a development flow
A set of validation requirements (as defined by the user), specifications, and regulations may be used as a basis for qualifying a development flow for a product, service, or system. Additional validation procedures also include those that are designed specifically to ensure that modifications made to an existing qualified development flow will have the effect of producing a product, service, or system that meets the initial design requirements, specifications, and regulations; these validations help to keep the flow qualified. It is a process of establishing evidence that provides a high degree of assurance that a product, service, or system accomplishes its intended requirements. This often involves acceptance of fitness for purpose with end users and other product stakeholders.