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OBJECTIVE To discuss the risk management methodology of data integrity implementation in drug quality control laboratories. METHODS The regulations and guidelines for data integrity were interpreted. How to apply quality risk management in data management was discussed, and combining the practical experience of laboratory, how to implement data integrity work in drug quality control laboratories through risk management was proposed. The focus was to systematically identify and map the processes, data flows, and systems of the laboratory based on the data life cycle, and analyze the gap between the current data management status and the regulation requirements. Then, using the risk management tools of ICH Q9, risk evaluation, control, and review need to be conducted to form a closed-loop risk management to control the data integrity risk within an acceptable range. RESULTS AND CONCLUSION Drug quality control laboratories should implement data management based on quality risk management principles. The implementation method proposed in this article can comprehensively evaluate and control the data integrity risks of the laboratory, which has strong practicality and can be used as a reference for other drug quality control laboratories.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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