【ECA新闻】新的MHRA指南对Excel的影响

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MS Excel is used inanalytical laboratories for many purposes - for example for calculations, andfrequently also for the storage of data. For electronically stored data, therehave been requirements since the formation of the EU GMP Guide. They are definedin Chapter 4 (Documentation) and in the complementary Guideline (Annex 11),which both have been revised a few years ago. This year (in March 2015), theBritish MHRA has summarised and interpreted the existing GMP requirements fordata security in a new guideline ("MHRA GMP Data Integrity Definitions andGuidance for Industry").
MS Excel在分析实验室应用有很多用途-比如计算，另外也经常用来储存数据。对于电子储存的数据，自从EU GMP指南发布以来已经有所要求。他们在第四章（文件）以及补充指南（附录11）进行了定义，在几年前已经进行了修订。今年（2015年3月），英国MHRA在一本新的指南中已经总结并解释了现有的GMP对数据安全的要求。（“MHRA GMP数据完整性定义和行业指南”）

Please also see the GMP news from February 2015 with regard to thenew MHRA Guideline and from April 2015 relative to the short-termrevision of the MHRA Guideline for data integrity.

也请参见从2015年2月以来的关于新的MHRA指南以及从2015年4月关于针对数据完整性的MHRA指南短期修订的GMP新闻。

Theserequirements apply to all electronically stored data - regardless of thetechnology used. Therefore, they also apply to data stored in Excel. MS Excelalone has not the functionality required for ensuring the integrity andtransparency of stored data. For saving GMP-relevant datain Excel files both additional organizational measures (e.g. procedures) ANDappropriate tools (e.g., document management systems, VBA, or commercial Excelextensions) are needed. That way, GMP compliance can also be accomplished fordata saving Excel applications.
这些要求适用于所有电子储存的数据—不论所使用的技术。因此，他们同样适用于在Excel中储存的数据。单独的MS Excel并没有确保储存的数据完整性和透明度的功能。在Excle文件中保存GMP相关的数据需要同时有额外的组织方法（例如，规程）和适当的工具（例如，文件管理系统，VBA或商业的Excel扩展）。这样，通过Excel程序保存的数据也可以满足GMP符合性。

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