1 回答
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。
