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记录/台账类电子表格的数据完整性要求

GMP办公室2019-01-13 06:47:16

MS Excel is used in analytical laboratories for many purposes - for example for calculations, and frequently also for the storage of data. For electronically stored data, there have been requirements since the formation of the EU GMP Guide. They are defined in Chapter 4 (Documentation) and in the complementary Guideline (Annex 11), which both have been revised a few years ago. This year (in March 2015), the British MHRA has summarised and interpreted the existing GMP requirements for data security in a new guideline ("MHRA GMP Data Integrity Definitions and Guidance for Industry"). Please also see the GMP news from February 2015 with regard to the new MHRA Guideline and from April 2015 relative to the short-term revision of the MHRA Guideline 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(20153月),英国药监MHRA在新的指南(MHRAGMP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ECA20152月公布的GMP新闻。

These requirements apply to all electronically stored data - regardless of the technology used. Therefore, they also apply to data stored in Excel. MS Excel alone has not the functionality required for ensuring the integrity and transparency of stored data. For saving GMP-relevant data in Excel files both additional organizational measures (e.g. procedures) AND appropriate tools (e.g., document management systems, VBA, or commercial Excel extensions) are needed. That way, GMP compliance can also be accomplished 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。

 

编者:GMP办公室昨天推送了关于模板类EXCEL电子表格的合规管理要求,今天为大家推送的是关于具备数据记录或者存储功能的EXCEL电子表格的合规要求。按照ECA发布的新闻,并不排斥EXCEL类电子表格作为电子记录或者电子台账的一种形式,但是需要额外的措施来确保存储在EXCEL里面的数据不被恶意/无意的更改,当然实现这次措施同时也需要验证支持。后续GMP办公室将探讨EXCEL如何实现数据完整性的具体措施,敬请关注!!!

 

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