Particular requirements for sterile medical devices Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 150 of 248 The manufacturer shall maintain records of the process parameters for the sterilization process which was used for each sterilization batch. Sterilization records shall be traceable to each production batch of medical device. Validation of processes for production and service provision: 7.5.2.1 General 7.5.2 The manufacturer shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement. This includes any processes where deficiencies become apparent only after the product is in use. Validation shall demonstrate the ability of these processes to achieve planned results. The manufacturer shall establish arrangements for these processes including, as applicable:— (a) defined criteria for review and approval of the processes; (b) approval of equipment and qualification of personnel; (c) use of specific methods and procedures; (d) requirements for records; and (e) revalidation. The manufacturer shall establish documented procedures for the validation of the application of computer software (and its changes to such software or its application) for production and service provision that affect the ability of the product conform to specified requirements. Such software applications shall be validated prior to initial use. Records of validation shall be maintained.