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To assess the long-term outcomes of glaucoma patients, a quality management system is established for the Japanese registry, ensuring regulatory-standard data quality. A quality management system was developed, its structure mirroring the risk-based approach advocated in the ICH-E6 (R2) recommendations. A three-part approach was undertaken, involving the establishment of governance, computerized system validation, and the implementation of risk assessment and control. The process of assessing the syste