MHRA新博客第2部分---GMP数据的完整性

20150812 ECA新闻：MHRA新博客第2部分---GMP数据的完整性  
GMP News
12/08/2015
The integrity of GMP data - part 2 of the new MHRA blog
MHRA新博客第2部分---GMP数据的完整性
To the MHRA, data integrity is a significant, high priority theme right now. Above and beyond the existing Data Integrity Guidelines, the MHRA developed a new blog on the theme in June.
目前对于HMRA来说，数据完整性是一个非常重要，优先度很高的主题。除了已有的数据完整性指南外，MHRA还在6月份开了一个新的关于此主题的博客。
Part 1 of the MHRA Good Manufacturing Practice (GMP) Data Integrity blog was subject in the news Integrity of GMP Data - New MHRA Blog!
MHRA的GMP数据完整性博客第1部分在新闻里说过了。
The second blog went live on 16 July 2015. It is all about the design of systems with which the quality and integrity of data can be ensured. This applies to both paper and computerised systems.
第二个博客在2015年7月16号上线。内容全是关于保证质量和数据完整性的系统设计的。它适用于纸质系统和计算机化系统。
A helpful, data-integrity-related acronym is ALCOA.
一个很有用的数据完整性有关的术语是ALCOA。
ALCOA stands for 'attributable', 'legible', 'contemporaneous', 'original' and 'accurate' as indicators of data administration system success. It includes the following aspects:
ALCOA代表“可追溯”“清晰”“同步”“原始”“准确”，这是数据管理系统成功的标识。它包括以下方面：
Attributable
The identity of the person who made the entry must be unique and obvious.
可追溯：对输入数据的人员身份有识别，是清楚唯一的。
Legible
It should not be possible to modify or restore records without an audit trail. And it is important not to forget paper records.
清晰：在没有审计追踪的前提下不能对数据做任何修改或恢复。不要忘记了纸质文件也是很重要的。
Contemporaneous
The records must be at the right place at the right time. This principle is illustrated using an example from the field of packaging operations.
同步：记录时间和位置必须正确。本原则使用了包装操作现场举例说明。
Original
The original data must preserve data accuracy, completeness, contents and meaning, including the meta data.
原始：原因数据保存必须准确、完整，包括内容和含义，包括元数据。
Accurate
Recording the data automatically with the necessary IT controls guarantees better overall control. In cases where automation is not possible, real-time verification by a second employee for quality-relevant values may be necessary.
准确：采用必要的IT控制来自动记录数据，以保证更好的全面控制。如果不可能采用自动记录，则需要由具备适当资质的第二个员工进行实时核查。
You will find the complete blog at MHRA blog Good Manufacturing Practice (GMP) data integrity-a-new-look-at-an-old-topic Part 2.
在MHRA的博客上你可以找到完整的内容。
Source: MHRA, UK

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