Design validation shall include software validation and risk analysis, where appropriate. The results of the design validation, including identification of the design, method(s), the date, and the individual(s) performing the validation, shall be documented in the DHF.
Design validation should include software validation and risk analysis, where applicable. The findings of the design validation, including identification of the design, method(s), date, and individual(s) performing the validation, must be documented in the DHF.