Sterilization: (i) Where the device is supplied sterile, the dossier should contain the detailed information of the initial sterilization validation including Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India. sterilizer qualification, bio-burden testing, pyrogen testing, testing for sterilant residues (if applicable) and packaging validation as per prescribed standards. Typically, the detailed validation information should include the method used, sterility assurance level attained, standards applied, the sterilization protocol developed in accordance with prescribed standards, and a summary of results. (ii) Evidence of the ongoing revalidation of the process should also be provided. Typically this would consist of arrangements for, or evidence of, revalidation of the packaging and sterilization processes. 7.6 Software verification and validation: The dossier should contain information on the software design and development process and evidence of the validation of the software, as used in the finished device. This information should typically include the summary results of all verification, validation and testing performed both in-house and in a simulated or actual user environment prior to final release. It should also address all of the different hardware configurations and, where applicable, operating systems identified in the labelling.