电子表格怎么合规（七）:额外的操作规程和工具是必要的

恨我不成钢

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.

Excel一直为分析实验室基于各种目的所使用，如计算，经常也用于数据存储。对于电子存储的数据，自从欧盟GMP指南的发布以来，它们一直被要求。这在几年前修订的（GMP指南）第4章（文档）和补充指南（附录11）作了定义。今年（2015三月），英国MHRA在一个新的指南（“MHRA的GMP数据完整性的定义和行业指南”）中总结和解释现有的GMP对数据安全的要求。也请在看到2015二月 发布的GMP新闻“新的英国指南”和在2015四月发布的关于MHRA指南对数据完整性的短期修正。

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储的数据，不管使用何种技术。因此，他们也适用于存储在Excel的数据。Excel本身不具备保证完整性和存储数据的透明度所需的功能。为了在Excel文件中保存GMP相关的数据，额外的组织措施（如规程）和适当的工具（例如，文档管理系统，VBA，或商业Excel扩展）是必要的。这样，Excel应用程序储存数据的GMP符合性也就实现了。

jinpt

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