PDA节选-洁净室的数据完整性问题-中英文版

洁净室的数据完整性问题

----本文摘自PDA电子期刊，适用于在线粒子系统和便携式粒子计数器：When carrying out reviews of particlecounters five general and important data integrity questions are:

在进行粒子计数器的审查时，有5个常见且重要的数据完整性问题：

∙Is electronic data available?

∙是否有电子数据？

∙Is electronic data reviewed?

∙是否对电子数据进行审核？

∙Is meta data (audit trails) reviewedregularly?

∙元数据(审计追踪)是否定期审核？

∙Are there clear segregation ofduties?

∙是否有明确的职责分工？

∙Has the system been validated for itsintended use?

∙系统的预期用途是否经过验证？

To add to theabove, ensuring that the counter has been calibrated by

a competent person andits optical sensors are free from

contamination, enable the data collected tobe reliable and

representative of the cleanroom environment.

此外，亦须确保计数器已由合适的人员校正，其光学传感器亦没有受到污染，以确保所采集的数据可靠并能代表洁净室环境。

In addition tothese broader questions, individual particle counters should be assessedagainst regulatory data integrity expectations. The types of data integrityissues which can impact upon a particle counter, and thus which need anassessment, include:

除了这些广泛的问题，粒子计数器应根据监管数据完整性的期望进行评估。数据完整性问题的类型可能影响粒子计数器，因此需要进行评估，包括:

1. Lack of definitions of data, leadingto incorrect record storage. This can arise if personnel are unaware of whatthe raw data and the original record are (such as a print-out or a pdf ofparticle data), what comprises a complete record. The definition of data shouldbe captured in a procedure.

缺乏数据的界定，导致不正确的记录存储。如果人员不知道哪些是原始数据和原始记录(如打印输出或粒子数据的pdf)？一份完整记录由什么组成？那么就会出现这种情况。应在规程中描述数据的界定。

2. System access. Particle countersshould require password access, with each user having a unique password. Thisensures that each particle counting event is tied to a specific user, with dateand time information additionally captured.

系统访问。粒子计数器应要求密码访问，每个用户都应有一个唯一的密码。这可以确保每个粒子计数事件都追溯到具体的用户，取样日期和时间。

3. Hierarchy of control. The particlecounter should come equipped with different levels of access. This wouldinclude, as a minimum, a basic user, who can turn the counter on and off; asupervisor level, who can change location settings and review audit trails; andan administrator who can change limits or delete data or clear buffers. Theadministrator is typically someone independent of the users, as required indata integrity guidance, and ideally independent of the departments who use theparticle counter.

控制等级。粒子计数器应该配备不同级别的访问权限。这至少包括，一个基础用户，可以开启和关闭计数器；一个主管级别用户，可以改变采样点设置和审查审计追踪；以及一个管理员账户，可以改变限度或删除数据或清除缓存。管理员通常由独立于用户的人员担任，正如数据完整性指南要求的那样，理想情况下是独立于粒子计数器的使用部门。

With control oflocation settings, technology is available for remote particle counters wherethe location identification is embedded in a location mounting bracket ratherthan the particle counter, which is more reliable for trending a given locationof the level of airborne particles at a specified position in the cleanroom.

对于采样点设置的控制，可以利用技术将位置标识嵌入位置安装支架而不是远端的粒子计数器中，这种技术对于在洁净室指定位置确定空气中粒子水平的给定位置更为可靠。