实验室数据完整性.docxVIP

PAGE1 / NUMPAGES2 实验室数据完整性 影响实验室数据完整性的过程，有以下几方面： 样品的完整性 标准物质和溶液的完整性 实验室仪器和计算机化系统 熟练的分析人员 记录和结果报告 分析方法验证和确认 ? 图1：影响实验室数据完整性的过程 ? 对于嵌套数据，数据处理见图2所示, 这里要确保每一步处理的可靠性和数据的可追溯性。 ? 图2 ? 结合WHO官方在2020年2月17~20日对某QC实验室常规检查报告中的内容来看一下WHO官方对实验室仪器和计算机化系统的数据完整性的检查。 ? ? 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