In addition, the manufacturer shall assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements. The manufacturer shall take appropriate action on the equipment and any product affected. Records of the results of calibration and verification shall be maintained. When used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy the intended application shall be confirmed. This shall be undertaken prior to initial use and reconfirmed as necessary. 8. Measurement, analysis and improvement 8.1 General The manufacturer shall plan and implement the monitoring, measurement, analysis and improvement processes needed— (a) to demonstrate conformity of the product; (b) to ensure conformity of the quality management system; and (c) to maintain the effectiveness of the quality management system. This shall include determination of applicable methods, including statistical techniques, and the extent of their use. Note : If relevant Indian standards are not available, International standards are applicable. In case no Indian or International standards are available, validated testing process of the manufacturer is applicable. Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 154 of 248 8.2 Monitoring and measurement 8.2.1 Feedback: As one of the measurements of the performance of the quality management system, the manufacturer shall monitor information relating to whether the manufacturer has met customer or regulatory requirements. The methods for obtaining and using this information shall be determined. The manufacturer shall establish a documented procedure for a feedback system to provide early warning of quality problems and for input into the corrective and preventive action processes.