Verfication & Validation

  1. Verification is a Quality control process that is used to evaluate whether or not a product, service, or system complies with regulations, specifications, or conditions imposed at the start of a development phase. Verification can be in development, scale-up, or production. This is often an internal process.
  2. Validation is a Quality assurance 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. The purpose of Validation (VAL) is to demonstrate that a product or product component fulfils its intended use when placed in its intended environment.

It is sometimes said that validation can be expressed by the query "Are you building the right thing?" and verification by "Are you building it right?" "Building the right thing" refers back to the user's needs, while "building it right" checks that the specifications are correctly implemented by the system. In some contexts, it is required to have written requirements for both as well as formal procedures or protocols for determining compliance.

Three practices of the validation process

The specific practices of this process area build on each other in the following way:
  • To identify a product or product component to be validated and the methods to be used to perform the validation.
  • To determine the environment that will be used to carry out the validation.
  • To develop validation procedures and criteria those are aligned with the characteristics of selected products, customer constraints on validation, methods, and the validation environment.
  • To perform validation according to the methods, procedures, and criteria.