电子表格怎么合规三（1）——符合计算机化系统验证规则的验证实践（其他附件）

恨我不成钢

Appendix C – Workbook Display & Printouts
附件 C-工作表显示和打印输出
This section includes visual images of how the spreadsheet looks on screen andhow any printed output looks. It is invaluable in allowing the reader to get a clearpicture of the how the spreadsheet works and processes data. This section is also vital as theprinted output is often the information that is submitted for regulatory approval andstorage.
本章包括了电子表格在屏幕上以及其他打印输出的可视化图片。这对使读者清楚的理解电子表格是怎么样工作和处理数据是十分重要的。这部分也是非常重要的，因为打印输出经常是法规机构批准和储存要求提供的信息。
Appendix D – Macros Included In Workbook
附件 D-工作表中的宏
This section includes the source code printout of any macros included in thespreadsheet.
本章包括了电子表格中宏的源代码信息。
Appendix E – Training Records
附件 E-培训记录
This section includes evidence of the training records of developers of thespreadsheet as requested by 21 CFR Part113. For simple spreadsheets this would includeevidence of User Training in the use of Excel and in the requirements of 21 CFR Part 11 and computer systems validation.
本章包括了电子表格开发者培训记录的证据，这属于 21CFR Part11 要求。对于简单的电子表格，则包括 Excel 使用、21 CFR Part11 和计算机系统验证用户培训的证据。
For spreadsheets with macros it would include evidence of programmerqualifications and experience in VBA.
对于含有宏的电子表格，则还包括程序员资质和在 VBA 经验方面的证据。
Appendix F – Risk Assessment
附件 F-风险分析
This section documents the functional risk assessment (FRA) of the spreadsheet.The risk assessment will highlight risks associated with the use of the spreadsheet; each identified risk will be prioritised and critical risks will be mitigated. Thestandard approach used is GAMP6 based and very similar to the Risk Assessment Approaches for the Validation of Commercial Computerised Systems7 identified by other authors.
本章节包含了电子表格功能的风险评估。风险评估强调与电子表格使用相关的风险，每一个识别的风险均应优先考虑并且缓解关键的风险。标准的方法基于 GAMP并十分类似其他作者在 Risk Assessment Approaches for the Validationof Commercial Computerised Systems 中的定义。

lmq

学习了....

北重楼

参考一下

syhorchid

了解一下

jinpt

👍👍👍👍👍👍👍👍👍👍👍👍

laozhu0372

不错，谢谢分享~~~