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？
record是什么意思中文
∙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 theparticl
e 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。
4.    In relation to passwords and accesslevels, each instrument is expected to have an approved list of users alongwith their job titles. As people leave an organization, their user name andpassword need to be removed from the counter and the user list updated by theadministrator.
关于密码和访问级别，每台仪器都应有一份经核准的用户清单及其职务名称。当人员离职时，他们的用户名和密码需要从计数器中删除，并由管理员更新用户列表。
5.    Data capture, where data is capturedin temporary files. Unless particle counters are connected to a facilitiesmanagement system, the long-term storage of the raw data is not possible sincea typical portable particle counter will only hold a buffer ofa set number of data points and once the buffer is full the data isoverwritten. This means data must be printed-out or transferred at regularintervals in order to prevent data loss.
数据采集，如数据被采集到临时文件中。除非粒子计数器连接到设备管理系统，否则不可能长期保存原始数据，因为一个典型的便携式粒子计数器只能容纳一定数量数据点的缓存，一旦缓存满了，数据就会被覆盖。这意味着数据必须定期打印或传输，以防止数据丢失。
6.    Data retrieval, which follows on fromdata capture. This concerns the ability to retrospectively retrieve data aftera particle counting session and this is again linked to the ability to retrievestored data, which will be limited by the buffer overwriting and the inabilityto store data in an electronic format for long periods of time without removingthat data to a secondary source or turning that data into a record (print-outor pdf).
数据检索。这涉及到在粒子计数之后回顾性检索数据的能力，这又关系到已存储数据的检索能力，数据检索将受到缓存覆盖以及无法长时间以电子格式存储数据的限制，如不将数据转移到辅助来源或将数据转换为记录(打印输出或pdf)。
Where data canbe produced as a portable document file rather than as a print-out, this addsgreater security. The pdf cannot be adjusted, and the paper is less likely tofade. With the print-out, this is often on thermal paper, which is prone tofading. Where a facilities monitoring system is used this will bring with itsimilar data integrity concerns as with a particle counter. However, the data iscaptured electronically leading to fewer ‘touch points’compared with thestandalone counter where data typically has to be transcribed or entered into adatabase. Each data entry is a step where error can occur. Toovercome this, some particle counters have the functionality for datatransmission where data is transmitted via wired or wireless

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