Validation

Confirmation, through the provision of objective evidence (3.8.3), that the requirements (3.6.4) for a specific intended use or application have been fulfilled Note 1 to entry: The objective evidence needed for a validation is the result of a test (3.11.8) or other form of determination (3.11.1) such as performing alternative calculations or reviewing documents (3.8.5). Note 2 to entry: The word “validated” is used to designate the corresponding status. Note 3 to entry: The use conditions for validation can be real or simulated.