目的 研究探讨药检机构数据完整性和计算机系统验证技术。方法 结合国际国内法规要求及我国药检机构实验室数据完整性和计算机系统验证的现状,论述数据完整性和计算机系统验证的意义和必要性,并提出如何在药检机构开展数据完整性和计算机系统验证实践。结果 药检机构非常有必要建立一套符合国内国际规范的数据完整性和计算机系统验证的管理体系。结论 遵循GAMP5指导原则并结合药检机构实际情况执行数据完整性及计算机化系统验证的实践具有可行性。
关键词
信息化 /
数据完整性 /
计算机系统验证(CSV)
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中图分类号：
R951
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参考文献
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