Establish and maintain procedures and criteria for validation.
Validation procedures and criteria are defined to ensure that the product or product component will fulfill its intended use when placed in its intended environment. Acceptance test cases and procedures may meet the need for
validation procedures.
The validation procedures and criteria include test and evaluation of maintenance, training, and support services.
Examples of sources for validation criteria include the following:
· Product and product component requirements
· Standards
· Customer acceptance criteria
· Environmental performance
· Thresholds of performance deviation
Typical Work Products
1. Validation procedures
2. Validation criteria
3. Test and evaluation procedures for maintenance, training, and support
Subpractices
1. Review the product requirements to ensure that issues affecting validation of the product or product component are identified and resolved.
2. Document the environment, operational scenario, procedures, inputs, outputs, and criteria for the validation of the selected product or product component.
3. Assess the design as it matures in the context of the validation environment to identify validation issues.