Data Quality Management and Analysis
Data quality management in pharmacovigilance can be relied only on information gathered from the collection of individual case safety reports and other pharmacoepidemiological data. The quality of a pharmacovigilance data system can be defined as a measure of excellence or a state of being free from defects, deficiencies and significant variations and the data quality management includes all the activities that organizations use to direct, control and coordinate the quality of data. The resulting data output is analysed and assessed. Finally, conclusions are drawn and decisions made. Several functioning, well documented and transparent quality management systems will assist in data collection management and output production and in addition will help the pharmacovigilance end users and patients.