序号

报告内容

编译

Data processing equipment

数据处理设备

1

An inventory of computerised systems was available.

有一份计算机化系统的清单。

2

Electronic data was backed up at appropriate  regular intervals in accordance with SOP titled as “The guidelines for  creating backup copies of electronic data”. Software systems associated to  the instruments were connected to a backup program. Additionally, data was  regularly saved on an external hard drive, under appropriate supervision.  Another backup copy was prepared once a year.

电子数据按照名为“电子数据备份指南”的SOP，按适当的定期间隔进行备份。与仪器相关的软件系统被连接到一个备份程序。此外，数据定期保存在一个外部硬盘中，并有适当的监管。每年再进行一次备份。

3

Concerning spreadsheets (e.g. Excel®), all cells including calculations  were locked so that formulas could not accidentally be overwritten. Free  access was only given to cells to be filled in with data. Calculation  algorithms were properly tested and confirmed. The validated Excel  spreadsheets were uploaded in the LIMS database system to provide protected  access by QA who also supervised and handled the obsolete versions. The used  spreadsheets were stored on the server in a specific folder. The sheets were  also printed out to be attached to the analytical documentation.

对于电子表格(如Excel®)，所有单元格包括计算都被锁定，因此公式不会意外被覆盖。只有要用数据填充的单元格才可以自由访问。对计算算法进行了适当的测试和验证。经过验证的Excel电子表格被上载到LIMS数据库系统中，以提供QA的保护访问，QA还监督和处理过时的版本。使用的电子表格存储在服务器的特定文件夹中。这些表格也打印出来，附在原始记录中。

4

Validation of computerized systems was initiated in accordance with an  SOP for Computerized Systems validation protocol. This SOP was mainly related  to the transfer of data from computer to the backup server for security of  storage of electronic data. The transfer of data from LIMS database to the  backup server was validated.

根据计算机化系统验证方案的SOP启动计算机化系统验证。该SOP主要涉及数据从计算机传输到备份服务器，以保证电子数据存储的安全性。验证了将数据从LIMS数据库传输到备份服务器。