Preparation for validation is conducted.
Validation preparation activities include selecting products and product components for validation and establishing and maintaining the validation environment, procedures, and criteria. Items
selected for validation may include only the product or it may include appropriate levels of product components 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. Environments used for
verification may be considered in collaboration with the validation environment to reduce cost and improve efficiency or productivity.
Expectations for validation which are typically included in the supplier agreement include the following:
· List of acquired products to be validated by the acquirer before formal acceptance
· List of products to be validated with customers, users, or other stakeholders by the supplier and applicable validation standards, procedures, methods, tools and criteria, if any
· Measurements to be collected and provided by the supplier with regard to validation activities
· Supplier roles in product and product component validation
· Validation environments to be used by the acquirer
· Validation procedures to be developed and criteria to be used for validation