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风清飞扬在 2023-10-26 22:48 发起了提问 数据完整性: 问答对在现场和/或非现场进行校准的合同校准服务供应商有什么期望？是否需要对这些公司的场所进行审计？

trer234: Using the principles of QRM to assess data criticality and risk, the company should include assessment of data governance systems implemented by the s...; 关注问题 1  0  0 评论

风清飞扬在 2023-10-26 22:47 发起了提问 数据完整性: 问答接受者（合同授予者）如何对供应商（合同接受者）提供的分析证书（CoA）等文件的有效性建立信心？

trer234: The recipient should have knowledge of the systems and procedures implemented at the supplier for the generation of the CoA. Arrangements should...; 关注问题 1  0  0 评论

风清飞扬在 2023-10-26 22:46 发起了提问 数据完整性: 问答对于外包给其他公司的GMP活动，我公司在数据完整性方面有什么责任？

trer234: Data integrity requirements should be incorporated into the company's contractor/vendor qualification/assurance program and associated procedure...; 关注问题 1  0  0 评论

风清飞扬在 2023-10-26 22:46 发起了提问 数据完整性: 问答对与数据完整性有关的自检计划有什么期望？

trer234: Ongoing compliance with the company's data governance policy/procedures should be reviewed during self-inspection, to ensure that they remain effectiv...; 关注问题 1  0  0 评论

风清飞扬在 2023-10-26 22:45 发起了提问 数据完整性: 问答基于风险的电子数据审查是否可以接受？

trer234: Yes. The principles of quality risk management may be applied during the review of electronic data and review by exception is permitted, when sc...; 关注问题 1  0  0 评论

风清飞扬在 2023-10-26 22:45 发起了提问 数据完整性: 问答为什么审查电子数据很重要？

trer234: In the case of data generated from an electronic system, electronic data is the original record which must be reviewed and evaluated prior to m...; 关注问题 1  0  0 评论

风清飞扬在 2023-10-26 22:44 发起了提问 数据完整性: 问答应采取哪些控制措施来确保原始电子数据得到保存？

trer234: Computerised systems should be designed in a way that ensures compliance with the principles of data integrity. The system design should make p...; 关注问题 1  0  0 评论

风清飞扬在 2023-10-26 22:43 发起了提问 数据完整性: 问答公司应如何设计和控制他们的纸质文件系统，以防止未经授权的GMP数据的重新出现？

trer234: The template (blank) forms used for manual recordings may be created in an electronic system (Word, Excel, etc.). The corresponding master docum...; 关注问题 1  0  0 评论

风清飞扬在 2023-10-26 22:43 发起了提问 数据完整性: 问答在Eudralex第4卷公布的与活性物质和剂型有关的现有欧盟GMP中，如何规定制药业的数据完整性期望（ALCOA）？

trer234: The main regulatory expectation for data integrity is to comply with the requirement of ALCOA principles. The table below provide for each ALCO...; 关注问题 1  0  0 评论

风清飞扬在 2023-10-26 22:42 发起了提问 数据完整性: 问答欧盟GMP是否要求实施数据完整性的具体程序？

trer234: There is no requirement for a specific procedure, however it may be beneficial to provide a summary document which outlines the organisations to...; 关注问题 1  0  0 评论

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