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.