15/04/2015
MHRA revises its Guideline on Data Integrity in the short Term
MHRA修订了其数据完整性指南
The topic "Data Integrity" (electronically generated data as well as data on paper) has moved up recently in the ranking of the most important "hot GMP topics" - not least due to the fact that insufficient or missing data integrity have increasingly been cited as a GMP violation in FDA warning letters.
题为“数据完整性”（电子产生的数据以及纸质数据）已在最近变成了最重要“GMP热点话题”---不仅是由于越来越多的数据完整性问题被当作GMP违规记载在在FDA警告信中。
Just this past January the British authority MHRA has already published a "Data Integrity Guidance" which industry and associations commented on extensively. Already in March a revised version of this guidance was published. This revision is more accurate in some places and partially appears more rigorous with regard to the authority's expectations. Here are some examples:
就在1月份，英国药监MHRA已经公布了一个“数据完整性指南”，行业和协会对它有广泛的评价。在3月份，就已经公布了该指南的修订版本。该修订在某些地方更加精确，关于药监机构的期望方面则有一部分显得更加强硬。这里有一些例子：
- Primary Record: In the event that primary data are recorded simultaneously by multiple systems, the system that generates and stores the data has to be defined. A risk assessment respectively a risk management has to ensure that the so-defined primary records have the maximum possible accuracy, completeness and relevance. It is not allowed to define so-called static data (prints or manual records), if there are dynamic (electronic) data as primary records. If there are data anomalies (e.g. OOS results), all data (static and dynamic) will have to be included in a risk-based investigation.
- 原始记录：如果原始数据是由多用途系统同步记录，则产生数据和存贮数据的系统必须进行界定。要根据风险评估制订风险管理，必须保证界定的原始记录具有最大可能程度的准确性，完整性和相关性。如果原始数据是动态数据（电子的），则不允许定义所谓的静态数据（打印或手工记录）。如果有导常数据（例如OOS结果），所有数据（静态和动态）均必须包括在基于风险的调查中。
- True Copy: The new guidance defines a "true copy" as a precise and verified copy of an original recording. This record can either be static (pure paper records or a non-editable electronic file in pdf-format) or dynamic (editable electronic file in which, for instance, certain sections of a diagram can be enlarged or expanded). The MHRA expects critical data to be stored in dynamic form to make sure that in inspections they can get to detailed information, which cannot be retrieved with static data.
- 真实复印件：新的指南定义“真实复印件”为一个精确的验证过的原始记录的复制品。该记录可以是静态的（纯纸质记录或不可编辑的PDF电子文件）或动态的（可编辑的电子文件，例如，图表的某些部分可以被放大或扩展）。MHRA期望关键数据是以动态形式保存，以保证在检查中可以获得详细信息，而静态数据则可能就无法恢复。
- System Administrator Access: According to the new guidance, the authority expects that the generic system administrator access is not used. Instead every employee with administrative privileges is supposed to log in only with his individual password, to ensure that the actions recorded in the audit trail can be associated with the respective person.
- 系统管理权限：根据新的指南，药监机构期望其它人不要冒用系统管理员的权限。相反，要求每个员工均有自己的管理权限，只能使用自己的个人密码登录，保证所有记录在审计追踪里的活动均伴随有相应的人员信息。
更多信息，参见上述链接下载指南。
非常滴资料哦！