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.