VALIDATION ENGINEERING (ML3)
The purpose of Validation (VAL) is to demonstrate that a product or product component fulfills its intended use when placed in its intended environment.
SG 1 Preparation for validation is conducted.
SP 1.1 Select products and product components to be validated and validation methods to be used.
SP 1.2 Establish and maintain the environment needed to support validation.
SP 1.3 Establish and maintain procedures and criteria for validation.
SG 2 The product or product components are validated to ensure they are suitable for use in their intended operating environment.
SP 2.1 Perform validation on selected products and product components.
SP 2.2 Analyze results of validation activities.
