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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?

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trer234 一阶会员 用户来自于: 广东省深圳市
2023-10-26 22:47

 Data integrity requirements should be incorporated into the company's contractor/vendor qualification/assurance program and associated procedures.

数据完整性要求应被纳入公司的承包商/供应商资格/保证计划和相关程序。

In addition to having their own data governance systems, companies outsourcing activities should verify the adequacy of comparable systems at the contract acceptor. The contract acceptor should apply equivalent levels of control to those applied by the contract giver.

除了拥有自己的数据治理系统外,外包活动的公司应核实合同接受者的类似系统是否充分。合同接受者应采用与合同给予者相当的控制水平。

Formal assessment of the contract acceptors competency and compliance in this regard should be conducted in the first instance prior to the approval of a contractor, and thereafter verified on a periodic basis at an appropriate frequency based on risk.

在批准承包商之前,应首先对合同接受者在这方面的能力和遵守情况进行正式评估,此后再根据风险情况以适当的频率进行定期核查。


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发布时间
2023-10-26 22:46
更新时间
2023-10-26 22:47
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