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The application research of data integrity in quality control of quality control laboratories
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Cai-tong HUANG1, 2, Zhe HUANG1, *
Chinese Journal of New Drugs | 2026, 35(15) : 1577 - 1583
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Chinese Journal of New Drugs | 2026, 35(15): 1577-1583
The application research of data integrity in quality control of quality control laboratories
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Cai-tong HUANG1, 2, Zhe HUANG1, *
Affiliations
  • 1Shenyang Pharmaceutical University, Shenyang 110016, China
  • 2BeOne Guangzhou Biologics Manufacturing Co., Ltd.,Guangzhou 510530, China
Published: 2026-08-15 doi: 10.20251/j.cnki.1003-3734.2026.15.002
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Data integrity, as the foundation of quality control (QC) in pharmaceutical enterprises, is directly related to the reliability of drug safety and regulatory compliance. This study focuses on the current state of data management in QC laboratories, identifying the risks to data integrity, and analyzing key aspects of data collection, storage, and protection through typical case studies. Furthermore, by optimizing management processes, strengthening personnel training, and introducing advanced technological systems, a comprehensive strategy to enhance data integrity is proposed. The research confirms that the integrated application of various systems and intelligent technical tools such as the laboratory information management system, microbiological information management system, computerized maintenance management system, warehouse management system and laboratory execution system can effectively ensure full-cycle management of samples, reagents, equipment, and testing data. Case studies further validate the practical effectiveness of the proposed data integrity strategies, providing important references for quality control in pharmaceutical QC laboratories. The study indicates that as regulatory requirements continue to rise, data integrity management will evolve towards intelligent and automated approaches, thereby promoting the continuous improvement of the pharmaceutical industry's quality management system.

data integrity  /  quality control laboratory  /  quality control  /  information technology system
黄才桐, 黄哲. 数据完整性在质量控制实验室质量控制中的应用研究. 中国新药杂志, 2026 , 35 (15) : 1577 -1583 . DOI: 10.20251/j.cnki.1003-3734.2026.15.002
Cai-tong HUANG, Zhe HUANG. The application research of data integrity in quality control of quality control laboratories[J]. Chinese Journal of New Drugs, 2026 , 35 (15) : 1577 -1583 . DOI: 10.20251/j.cnki.1003-3734.2026.15.002
Year 2026 volume 35 Issue 15
40
13
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doi: 10.20251/j.cnki.1003-3734.2026.15.002
  • Online Date:2026-10-26
  • Published:2026-08-15
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  • Accepted:2025-08-15
Affiliations
    1Shenyang Pharmaceutical University, Shenyang 110016, China
    2BeOne Guangzhou Biologics Manufacturing Co., Ltd.,Guangzhou 510530, China
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表12种不同金属材料的力学参数
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Family
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Number of
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Number of
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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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