Establish the Validation Environment
Establish and maintain the environment needed to support validation.

The requirements for the validation environment are driven by the product or product components selected, by the type of the work products (e.g., design, prototype, final version), and by the methods of validation. These may yield requirements for the purchase or development of equipment, software, or other resources. These requirements are provided to the requirements development processes for development. The validation environment may include the reuse of existing resources. In this case, arrangements for the use of these resources must be made. Examples of the type of elements in a validation environment include:

Early selection of the products or product components to be validated, the work products to be used in the validation, and the validation methods is needed to ensure that the validation environment will be available when necessary.

The validation environment should be carefully controlled to provide for replication, analysis of results, and re-validation of problem areas.