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为了能够为制药企业开展、完善数据完整性工作提供参考和帮助,本文对药品质量控制数据完整性管理工作的相关问题做了总结,本文作者认为数据完整性是药品质量管理的需要,是行业选择的需要,是日益增加的监管意识的需要。
In order to provide reference and help for the pharmaceutical enterprises to improve and complete the data integrity, this paper summarizes the related issues of the data integrity management of pharmaceutical quality control. The author of this article thinks that the data integrity is the need of the pharmaceutical quality management and the choice of the industry The need is the growing need for regulatory awareness.