There is no requirement for a specific procedure, however it may be beneficial to provide a summary document which outlines the organisations total approach to data governance.

对具体的程序没有要求，但提供一份概述组织对数据治理的总体方法的摘要文件可能是有益的。

A compliant pharmaceutical quality system generates and assesses a significant amount of data. While all data has an overall influence on GMP compliance, different data will have different levels of impact to product quality.

一个合规的药品质量体系会产生和评估大量的数据。虽然所有的数据都对GMP符合性有整体影响，但不同的数据会对产品质量产生不同程度的影响。

A quality-risk management (ICH Q9) approach to data integrity can be achieved by considering data risk and data criticality at each stage in the Data lifecycle. The effort applied to control measures should be commensurate with this data risk and criticality assessment.

通过在数据生命周期的每个阶段考虑数据风险和数据关键性，可以实现质量-风险管理（ICH Q9）的数据完整性方法。应用于控制措施的努力应与这种数据风险和关键性评估相称。

The approach to risk identification, mitigation, review and communication should be iterative, and integrated into the pharmaceutical quality system. This should provide senior management supervision and permit a balance between data integrity and general GMP priorities in line with the principles of ICH Q9 & Q10.

风险识别、缓解、审查和沟通的方法应该是反复进行的，并整合到制药质量体系中。这应提供高级管理层的监督，并允许根据ICH Q9和Q10的原则，在数据完整性和一般GMP优先事项之间取得平衡。