Establish Validation Procedures and Criteria
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:
Product and product-component requirements
Standards
Customer acceptance criteria
Environmental performance
Thresholds of performance deviation
- Review the product requirements to ensure that issues affecting
validation of the product or product component are identified and
resolved.
- Document the environment, operational scenario, procedures,
inputs, outputs, and criteria for the validation of the selected
product or product component.
- Assess the design as it matures in the context of the validation
environment to identify validation issues.