EXCEL电子表格验证规范

If your spreadsheet supports any activity governed by applicable regulations, then it should be validated. Companies have been cited by FDA for not validating spreadsheets used for in-process analytical calculations, finished product analytical calculations, tracking and trendy quality metrics, and for their databases or lists.

，则必须被验证。FDA引用了多家公司未对其用于工艺过程分析计算、成品分析计算、跟踪和分析质量量度趋势及其数据库或列表的电子表格进行验证。

Here are a few commonly found errors:

一些常见的问题如下：

·         Spreadsheet files not maintained, some deleted

·         电子表格文件没有维护，甚至被删除

·         Rounding errors

·         数据取舍误差

·         Formulas don't match

·         公式不匹配

·         Conversion factors issues

·         单位换算公式的问题

·         Spreadsheet doesn't show specs or limits

·         电子表格没有显示规格和限度

·         Unclear documentation

·         文件记录不明确

·         Security and data integrity issues   

·         安全和数据可靠性问题

Thankfully, here are a few pointers from our last Computer and Software Validation conference to help you validate your spreadsheets:

幸运的是，近期，计算机和软件验证会议给出了一些指导帮助我们验证我们的电子表格

·         Lock all non-input cells

·         锁定所有不需要输入的单元格

·         Make spreadsheets read-only, with password protection

·         使电子表格只读，通过密码保护

·         Automatically reject data outside valid ranges

·         自动拒绝超出有效范围的数据

·         Test by entering expected and extreme values, and nonsensical data

·         通过输入期望数值、极端数值和无效数据来测试

·         Keep record of all cell formulas

·         保存所有单元格公式的记录

·         Document changes made to the spreadsheet

·         记录对电子表格所做的变更

·         Change control with version numbers

·         使用版本号进行变更控制

·         Re-validate spreadsheets periodically, including cell formula verification and manual verification of spreadsheet calculations

·         定期在验证电子表格，包括单元格公式确认和计算结果的人工确认