Preparation for validation is conducted.

Preparation activities include selecting products and product components for validation and establishing and maintaining the validation environment, procedures, and criteria. The items selected for validation may include only the product or it may include appropriate levels of the product components that are used to build the product. Any product or product component may be subject to validation, including replacement, maintenance, and training products, to name a few.

The environment required to validate the product or product component is prepared. The environment may be purchased or may be specified, designed, and built. The environments used for product integration and verification may be considered in collaboration with the validation environment to reduce cost and improve efficiency or productivity.