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"数据生命周期"。在数据寿命结束时,以受控方式退役或处置数据时,应考虑哪些风险?

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trer234 一阶会员 用户来自于: 广东省深圳市
2023-10-26 22:42

 The following aspects should be considered when determining risk and control measures:

在确定风险和控制措施时,应考虑以下方面。

· The data retention period

数据保留期

This will be influenced by regulatory requirements and data criticality. When considering data for a single product, there may be different data retention needs for pivotal trial data and manufacturing process / analytical validation data compared to routine commercial batch data.

这将受到监管要求和数据重要性的影响。当考虑单一产品的数据时,与常规商业批次数据相比,关键性试验数据和制造工艺/分析验证数据可能有不同的数据保留需求。

· How data disposal is authorised

如何授权进行数据处理

Any disposal of data should be approved within the quality system and be performed in accordance with a procedure to ensure compliance with the required data retention period.

任何数据的处理都应在质量体系内得到批准,并按照程序执行,以确保符合规定的数据保留期。


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发布时间
2023-10-26 22:41
更新时间
2023-10-26 22:42
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