Analysis of data The manufacturer shall establish documented procedures to determine, collect and analyze appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate whether improvement of the effectiveness of the quality management system can be made. This shall include data generated as a result of monitoring and measurement and from other relevant sources. The analysis of data shall provide information relating to— (a) feedback; (b) conformity to product requirements; (c) characteristics and trends of processes and products including opportunities for preventive action; and (d) suppliers. Records of the results of the analysis of data shall be maintained. Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 157 of 248 8.5 Improvement 8.5.1 General: The manufacturer shall identify and implement any changes necessary to ensure and maintain the continued suitability and effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review. The manufacturer shall establish documented procedures for the issue and implementation of advisory notices. These procedures shall be capable of being implemented at any time. Records of all customer complaint investigations shall be maintained. If investigation determines that the activities outside the manufacturer's organisation contributed to the customer complaint, relevant information shall be exchanged between the organisations involved. If any complaint is not investigated, justification shall be documented. Any correction or corrective action resulting from the compliant handling process shall be documented. Manufacturer shall notify the adverse event to the regulatory authority and establish documented procedures for the same.