电子表格如何合规——EU GMP 附录11：计算机化系统问答

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1. Appropriate controls for electronic documents such astemplates should be implemented. Are there any specific requirements fortemplates of spreadsheets? H+V February 2011

对于电子文件，例如模板要进行适当的控制。这里对于数据表是否有什么特定的要求？H+V 2011年2月

Templates of spreadsheets help to avoiderroneous calculations from data remaining from previous calculations. Theyshould be suitably checked for accuracy and reliability (annex 11 p7.1). Theyshould be stored in a manner which ensures appropriate version control (chapter4 p4.1).

数据表的模板帮助避免之前计算保留数据导致的错误计算。针对数据表，要检查其准确性和可靠性（附录11页7.1）。数据表存贮方式要能保证适当的版本控制（第4章页4.1）。

2. What type of accuracy checks (annex 11 p 6) areexpected for the use of spreadsheets? H+V February 2011

使用数据表格时，要进行哪些准确度检查（附录11页5）？H+V 2011年1月

Data integrity should be ensured bysuitably implemented and risk-assessed controls. The calculations and the filesshould be secured in such a way that formulations are not accidentallyoverwritten. Accidental input of an inappropriate data type should be preventedor result in an error message (e.g. text in a numeric field or a decimal formatinto an integer field). So-called 'boundary checks' are encouraged.

应通过适当实施的和基于风险的控制来保证数据完整性。计算和文档应受到保护，公式不能被无意改写。能防止无意输入不适当的数据类型，或导致错误信息（例如，在数字域中输入文字或在整数域中输入小数）。鼓励进行所谓“边界测试”。

3. Are there any specific considerations for thevalidation of spreadsheets? H+V February 2011

数据表的验证有哪些需要特殊考虑的？H+V 2011年2月

Validation according to paragraph 4 ofannex 11 is required at least for spreadsheets that contain custom code (e.g.Visual Basic for applications). Formulas or other types of algorithm should beverified for correctness.

根据附录11第4段，对数据表格所需要进行的验证至少包括定制代码（例如visual Basic应用）。公式或其它计算输入应进行正确性核实。

大小王是王炸

请问这是什么标准？

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lmq

振鸣 发表于 2018-8-11 16:20
请问这是什么标准？

EU GMP附录11：计算机化系统问答

北重楼

谢谢楼主的分享

syhorchid

了解一下

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