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. Items selected for validation can include only the product or it can include appropriate levels of product components used to build the product. Any product or product component can 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 can be purchased or can be specified, designed, and built. Environments used for product integration and verification can be considered in collaboration with the validation environment to reduce cost and improve efficiency or productivity.


VAL.SP 1.1 Select Products for Validation
Select products and product components to be validated and the validation methods that will be used for each.
VAL.SP 1.2 Establish the Validation Environment
Establish and maintain the environment needed to support validation.
VAL.SP 1.3 Establish Validation Procedures and Criteria
Establish and maintain procedures and criteria for validation.