新MHRA的EXCEL指南发布后

20151104 ECA新闻：新MHRA的EXCEL指南发布后  

04/11/2015

Consequences of the new MHRA Guidelinefor Excel

新MHRA指南对EXCEL应用的影响

MS Excel is used in analyticallaboratories for many purposes - for example for calculations, and frequentlyalso for the storage of data. For electronically stored data, there have beenrequirements since the formation of the EU GMP Guide. They are defined inChapter 4 (Documentation) and in the complementary Guideline (Annex 11), whichboth have been revised a few years ago. This year (in March 2015), the BritishMHRA has summarised and interpreted the existing GMP requirements for datasecurity in a new guideline ("MHRA GMP Data Integrity Definitions andGuidance for Industry"). Please also see the GMP news from February 2015with regard to the new MHRA Guideline andfrom April 2015 relative to the short-term revision of the MHRAGuideline for data integrity.

MS EXCEL在化验室有很多用途---例如，用于计算，还常用于数据存贮。对于电子存贮的数据，自EU GMP指南建立以来就有了要求。这些要求放在第4章（文件记录）里以及补充指南（附录11）里，两者均在几年前进行了修订。今年（2015年3月），英国药监MHRA在新的指南（MHRA的GMP数据完整性定义和行业指南）中汇总并诠释了已有的数据安全方面的GMP要求。参见ECA在2015年2月公布的GMP新闻。

These requirements apply to allelectronically stored data - regardless of the technology used. Therefore, theyalso apply to data stored in Excel. MS Excel alone has not the functionalityrequired for ensuring the integrity and transparency of stored data. For savingGMP-relevant data in Excel files both additional organizational measures (e.g.procedures) AND appropriate tools (e.g., document management systems, VBA, orcommercial Excel extensions) are needed. That way, GMP compliance can also beaccomplished for data saving Excel applications.

这些要求适用于所有电子存贮的数据---不管使用了何种技术。因此，它们也适用于存贮在EXCEL里的数据。MS EXCEL本身并没有功能性要求来确保所存贮数据的完整性和透明度。为了将GMP相关数据存贮在EXCEL文件中，需要有另外的组织措施（例如，程序）和适当的工具（例如，文件管理体系，VBA或商用EXCEL扩展）。这样，存贮在EXCEL应用程序里的数据就具有了GMP符合性。

来源：http://zhuyujiao1972.blog.163.co ... 947272015105478139/