| 冯磊,王翀,朱炯.国家药品抽检工作中数字报告系统的应用研究[J].中国药事,2022,36(5):491-496 |
| 国家药品抽检工作中数字报告系统的应用研究 |
| Application Research of Digital Reporting System in National Drug Sampling Supervision |
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| DOI：10.16153/j.1002-7777.2022.05.002 |
| 中文关键词: 国家药品抽检 数字报告系统 数字报告 药品质量 质量评价 |
| 英文关键词: national drug sampling inspection digital reporting system digital reporting drug quality quality evaluation |
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| 摘要点击次数: 544 |
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| 中文摘要: |
| 目的： 开展国家药品抽检工作数字报告系统的应用研究，促进国家药品监管效率的提升方法： 根据国家药品抽检工作的特点，开发国家药品抽检工作数字报告系统，研究数字报告系统的设计及实现、工作流程及全过程维护，探讨数字报告系统的工作成效。结果与结论： 国家药品抽检工作数字报告系统能够自动实现国家药品抽检检验报告的电子化生成，使不同部门间数字报告对接和数字报告传递， 且能在线快速查询数字报告的真伪。通过日常维护，数字报告系统可以有效促进国家药品抽检工作的运转。国家药品抽检工作中的数字报告系统保障了国家药品抽检工作的高效、安全运行，为上市后药品的质量监管起到了积极有效的支撑作用，亦为类似数字报告系统的搭建提供了参考。 |
| 英文摘要: |
| Objective: To carry out the application research on the digital reporting system of national drug sampling work in order to increase the efficiency of national drug supervision. Methods: According to the characteristics of national drug sampling inspection, the digital reporting system of national drug sampling inspection was developed. The design and implementation of the digital system, the work flow and the whole process maintenance of the digital system were studied, and the effectiveness of the digital system was discussed. Results: The digital reporting system of national drug sampling inspection could automatically realize the electronic generation of national drug sampling inspection report so that the digital reports among different departments could be connected and transmitted, and the authenticity of digital reportscould be quickly queried online. Through routine maintenance, the digital reporting system could effectively promote the operation of national drug sampling inspection. Conclusion: The digital reporting system ensured the efficient and safe operation of national drug sampling work, played an active and effective supporting role in the quality supervision of drugs after listing, and also provided references for the construction of similar digital reporting systems. |
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