Summary

Preparation for validation is conducted.

Description

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 can be purchased or can be specified, designed, and built. Environments used for verification can 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, end users, or other relevant 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 to be taken 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

Contains

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