Validation

According to ISO 9000/2015 validation is: “The confirmation, through the provision of objective evidence that the requirements for a specific intended use or application have been fulfilled.” It should be noted that: › The objective evidence needed for validation is the result of a test or other form of determination such as performing alternative calculation or reviewing documents. › The word ‘’validated’’ is used to designate the corresponding status. › The use conditions for validation can be real or simulated. Validation is a process. It uses objective evidence to confirm that the requirements which define an intended use or application have been met. Whenever all requirements have been met, a validated status is established. Validation can be carried out under realistic use conditions or within a simulated use environment. There are several ways to confirm that the requirements which define an intended use or application have been met. For example, tests, calculations, simulations.