Records of the design and development outputs shall be maintained. Records of design and development outputs can include specifications, manufacturing procedures, engineering drawings, and engineering or research logbooks. Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 146 of 248 7.3.4 Design and development review: At suitable stages, systematic reviews of design and development shall be performed in accordance with planned arrangements— (a) to evaluate the ability of the results of design and development to meet requirements; and (b) to identify any problems and propose necessary actions. Participants in such reviews shall include representatives of functions concerned with the design and development stage being reviewed, as well as other specialist personnel. Records of the results of the reviews and any necessary actions shall be maintained. 7.3.5 Design and development verification: Verification shall be performed in accordance with planned arrangements to ensure that the design and development outputs have met the design and development input requirements. Records of the results of the verification and any necessary actions shall be maintained.7.3.6 Design and development validation: Design and development validation shall be performed in accordance with planned arrangements to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use. Design validation shall be performed under defined operating conditions on initial production units, lots, or batches or their equivalence. Design validation shall include software validation and risk analysis, where appropriate validation shall be completed prior to the delivery or implementation of the product. Records of the results of validation and any necessary actions shall be maintained.