In the case of data generated from an electronic system, electronic data is the original record which must be reviewed and evaluated prior to making batch release decisions and other decisions relating to GMP related activities (e.g. approval of stability results, analytical method validation etc.). In the event that the review is based solely on printouts there is potential for records to be excluded from the review process which may contain un-investigated out of specification data or other data anomalies. The review of the raw electronic data should mitigate risk and enable detection of data deletion, amendment, duplication, reusing and fabrication which are common data integrity failures. Example of an inspection citing:

在电子系统产生的数据的情况下，电子数据是原始记录，在作出批量放行决定和其他与GMP相关活动（如稳定性结果的批准、分析方法的验证等）的决定之前，必须对其进行审查和评估。如果审查只基于打印件，则有可能将可能包含未调查的超规格数据或其他数据异常的记录排除在审查过程之外。对原始电子数据的审查应能降低风险，并能发现数据的删除、修改、复制、重复使用和捏造等常见的数据完整性故障。检查的例子引证。

Raw data for HPLC/GC runs which had been invalidated was stored separately to the QC raw data packages and had not been included in the review process.

已经失效的HPLC/GC运行的原始数据与QC原始数据包分开保存，没有被纳入审查过程。

In the above situation, the procedure for review of chromatographic data packages did not require a review of the electronic raw data or a review of relevant audit trails associated with the analyses. This lead to the exclusion of records from the review process and to lack of visibility of changes made during the processing and reporting of the data. The company was unable to provide any explanation for the data which had been invalidated.

在上述情况下，对色谱数据包的审查程序没有要求审查电子原始数据或审查与分析有关的相关审计跟踪。这导致审查过程中排除了一些记录，并且对数据处理和报告过程中的变化缺乏了解。该公司无法对已经失效的数据提供任何解释。