电子表格怎么合规（六）：ECA的验证要求

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Everyone uses Excel Spreadsheets. Also in pharmaceutical companies, Excel Spreadsheets are used in different departments. The easy to use calculations allow making calculations in a very convenient way. Yet, this can also represent a huge risk. In a pharmaceutical environment, computerized systems need to be validated. Spreadsheets also need to comply with a number of requirements. However, controls are quite often inadequate and this may result in a compliance risk.
每个人都在使用Excel电子表格。同时在制药公司，Excel电子表格的使用在不同的部门。易于使用的计算使得计算变得非常方便。然而，这也代表了一个巨大的风险。在医药环境，计算机系统需要进行验证。电子表格中也需要遵守一些要求。然而，控制经常不足，这可能导致合规风险。
When it comes to spreadsheets, what should be validated? A Q&A issued by EMA provides the following answer: "Validation according to paragraph 4 of annex 11 is required at least for spreadsheets that contain custom code (e.g. Visual Basic for applications). Formulas or other types of algorithm should be verified for correctness." Therefore, appropriate controls for templates of spreadsheets must be in place. Erroneous calculations due to data remaining from previous calculations must be avoided. The templates should also be suitably checked for accuracy and reliability (annex 11 p7.1) and should be stored in a manner which ensures appropriate version control (chapter 4 p4.1).
当涉及到电子表格，应该怎样验证呢？一个问答发布EMA提供以下回答：“验证根据附录11 第4段要求，至少包含自定义代码的电子表格（例如Visual Basic应用程序）。公式或其他类型的算法应该证实其正确性。”因此，电子表格模板的适当的控制必须到位。必须避免先前的计算剩余的数据导致的计算错误。模板也应适当检查准确性和可靠性（附件11 p7.1）并应以适当的方式存放以保证版本控制（4章对试验）。
When it comes to accuracy checks (as required in Annex 11 p 6), data integrity is an important issue. The Q&A document explains that both the files and the calculations should be secured in such a way that formulations are not accidentally overwritten. Accidental input of an inappropriate data type should be prevented or result in an error message.
说到精度检查（如附录11 P 6要求）、数据的完整性是一个重要的问题。问答文件说明了（Excel）文件和计算过程应固定在这样一种方式，公式不得被无意修改。意外输入一个不恰当的数据类型应被保护或者引起错误警告。

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感谢分享。