欧盟附录11计算机化系统验证,EU GMP问答-11 附录11 计算机化系统10问 201102

EUGMP guide annexes: Supplementary requirements: Annex 11: Computerised systems

EU GMP指南附录：补充要求：附录11：计算机化系统

1.Appropriate controls for electronic documents such as templates should beimplemented. Are there any specific requirements for templates 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 ofspreadsheets help to avoid erroneous calculations from data remaining fromprevious calculations. They should be suitably checked for accuracy andreliability (annex 11 p7.1). They should be stored in a manner which ensuresappropriate version control (chapter 4 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 typeof accuracy checks (annex 11 p 6) are expected for the use of spreadsheets? H+VFebruary 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 integrityshould be ensured by suitably implemented and risk-assessed controls. Thecalculations and the files should be secured in such a way that formulationsare not accidentally overwritten. Accidental input of an inappropriate datatype should be prevented or result in an error message (e.g. text in a numericfield or a decimal format into 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 thereany specific considerations for the validation of spreadsheets? H+V February2011

数据表的验证有哪些需要特殊考虑的？H+V 2011年2月

Validationaccording to paragraph 4 of annex 11 is required at least for spreadsheets thatcontain custom code (e.g. Visual Basic for applications).