When carrying out reviews of particlecounters five general and important data integrity questions are:
當進行粒子計數(shù)器的審查時，有5個常見和重要的數(shù)據(jù)完整性問題：
Is electronic data available?
是否有電子數(shù)據(jù)？
Is electronic data reviewed?
是否對電子數(shù)據(jù)進行審核？
Is meta data (audit trails) reviewedregularly?
元數(shù)據(jù)(審計追蹤)是否定期審核？
Are there clear segregation ofduties?
是否有明確的職責分工？
Has the system been validated for itsintended use?
系統(tǒng)的預期用途是否經(jīng)過驗證？
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，亦須確保計數(shù)器已由合適的人員校正，其光學傳感器亦沒有受到污染，以確保所采集的數(shù)據(jù)可靠并能代表潔凈室環(huán)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:
除了這些廣泛的問題，粒子計數(shù)器應根據(jù)監(jiān)管數(shù)據(jù)完整性的期望進行評估。數(shù)據(jù)完整性問題的類型可能影響粒子計數(shù)器，因此需要進行評估，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.
缺乏數(shù)據(jù)的界定，導致不正確的記錄存儲。如果人員不知道哪些是原始數(shù)據(jù)和原始記錄(如打印輸出或粒子數(shù)據(jù)的pdf)？一份完整記錄由什么組成？那么就會出現(xiàn)這種情況。應在規(guī)程中描述數(shù)據(jù)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.
系統(tǒng)訪問。粒子計數(shù)器應要求密碼訪問，每個用戶都應有一個唯一的密碼。這可以確保每個粒子計數(shù)事件都追溯到具體的用戶，取樣日期和時間。
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.
控制等級。粒子計數(shù)器應該配備不同級別的訪問權(quán)限。這至少包括，一個基礎(chǔ)用戶，可以開啟和關(guān)閉計數(shù)器；一個主管級別用戶，可以改變采樣點設(shè)置和審查審計追蹤；以及一個管理員賬戶，可以改變限度或刪除數(shù)據(jù)或清除緩存。管理員通常由獨立于用戶的人員擔任，正如數(shù)據(jù)完整性指南要求的那樣，理想情況下是獨立于粒子計數(shù)器的使用部門。
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.
對于采樣點設(shè)置的控制，可以利用技術(shù)將位置標識嵌入位置安裝支架而不是遠端的粒子計數(shù)器中，這種技術(shù)對于在潔凈室指定位置確定空氣中粒子水平的給定位置更為可靠。
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.
關(guān)于密碼和訪問級別，每臺儀器都應有一份經(jīng)核準的用戶清單及其職務名稱。當人員離職時，他們的用戶名和密碼需要從計數(shù)器中刪除，并由管理員更新用戶列表。
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.
數(shù)據(jù)采集，如數(shù)據(jù)被采集到臨時文件中。除非粒子計數(shù)器連接到設(shè)備管理系統(tǒng)，否則不可能長期保存原始數(shù)據(jù)，因為一個典型的便攜式粒子計數(shù)器只能容納一定數(shù)量數(shù)據(jù)點的緩存，一旦緩存滿了，數(shù)據(jù)就會被覆蓋。這意味著數(shù)據(jù)必須定期打印或傳輸，以防止數(shù)據(jù)丟失。
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).
數(shù)據(jù)檢索。這涉及到在粒子計數(shù)之后回顧性檢索數(shù)據(jù)的能力，這又關(guān)系到已存儲數(shù)據(jù)的檢索能力，數(shù)據(jù)檢索將受到緩存覆蓋以及無法長時間以電子格式存儲數(shù)據(jù)的限制，如不將數(shù)據(jù)轉(zhuǎn)移到輔助來源或?qū)?shù)據(jù)轉(zhuǎn)換為記錄(打印輸出或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 ethernet to asecure server where the user keeps the final records. This form of datatransfer can prove to be robust provided the process of data transfer has beenqualified.
如數(shù)據(jù)可以生成PDF文件而不是打印文件，將增加更大的安全性。PDF文檔不能修改，也不太可能褪色。而打印，往往是熱敏紙，很容易褪色。如果使用設(shè)施監(jiān)測系統(tǒng)，這將帶來與粒子計數(shù)器類似的數(shù)據(jù)完整性問題。然而，數(shù)據(jù)是通過電子方式捕獲的，因此與通常需要將數(shù)據(jù)轉(zhuǎn)錄或輸入數(shù)據(jù)庫的單機版計數(shù)器相比，“人工介入”更少。每個數(shù)據(jù)輸入都是可能發(fā)生錯誤的步驟。為了解決這個問題，一些粒子計數(shù)器具有數(shù)據(jù)傳輸?shù)墓δ?，通過有線或無線以太網(wǎng)將數(shù)據(jù)傳輸?shù)桨踩姆掌鳌Ｈ绻麛?shù)據(jù)傳輸過程經(jīng)過確認，這種形式的數(shù)據(jù)傳輸是可靠的。
7. File deletion can occur where raw dataand metadata (‘data about data’, such as the time of sampling) are deleted fromthe counter before the data has been printed-put or transferred.An effective counter will have different levels of password access, with datadeletion only permitted by an administrator. Furthermore, the counter shouldhave an electronic audit trail in place so that any deletion of data istraceable.
原始數(shù)據(jù)和元數(shù)據(jù)(“數(shù)據(jù)的數(shù)據(jù)”，如采樣的時間)在打印或傳輸之前，可能被刪除。一個有效的計數(shù)器將有不同的密碼訪問級別，只有管理員才允許刪除數(shù)據(jù)。此外，計數(shù)器應有電子審計追蹤，以便追蹤任何數(shù)據(jù)刪除行為。
8. System security. In relation to aparticle counter this relates to access to the clock and calendar functions. Itshould not be possible for the user to alter the date or time, and suchpermission should rest with the administrator. Where the time is changed (suchas switching from daylight saving) this must be captured in the audit trail.Not having the particle counter clock in synchronicity with ‘real time’ wouldresult in the inability to link any significant particle count fluctuations withspecific events.
系統(tǒng)安全。關(guān)于粒子計數(shù)器，這涉及到對時鐘和日歷功能的訪問。用戶不應該可以更改日期或時間，這種權(quán)限應交由管理員。當時間改變時(例如切換夏令時)，必須在審計追蹤中捕捉到這一點。粒子計數(shù)器時鐘不“實時”同步將導致無法將任何重大粒子計數(shù)波動與特定事件聯(lián)系起來。
9. A further best practice element ofdata integrity is what to do during a ‘disaster’. This can range from asystematic failure where no data can be recovered to failure of instruments.The expectation is that disaster scenarios are documented. While this isunlikely to go into a standard operating procedure for a counter it might becaptured in a site policy or position paper.
數(shù)據(jù)完整性的另一個最佳實踐要素是在“災難”期間應該做什么。“災難”可能是系統(tǒng)性故障，無法恢復數(shù)據(jù)，也可能是儀器故障。我們的期望是，災難預案形成文件。雖然這不太可能成為一個計數(shù)器的標準操作程序，但它可能會被寫入工廠的方針或立場文件。
Other Areas of Cleanroom Operations
潔凈室操作的其他領(lǐng)域
There are otherareas to which data integrity can be applied. These include the systemsdesigned to monitor cleanrooms for pressure differentials. Such data isrequired to assess that the pressure differential between adjacent areas of adifferent cleanroom class, or in relation to an airlock, have not fallen toolow or gone negative, as well as to assess trends so that performance of theoverall air control system can be assessed. As with the particle counter, thedata needs to be time and date related; to be backed-up or stored long-term. Inaddition, the data capture system needs to be password controlled.
還有其他適用數(shù)據(jù)完整性的領(lǐng)域。包括用于監(jiān)測潔凈室壓差的系統(tǒng)。這些數(shù)據(jù)用于評估不同潔凈級別的鄰近區(qū)域之間的壓差，或與氣閘有關(guān)的壓差，沒有降得太低或變成負值，以及評估趨勢，以便評估整個空調(diào)系統(tǒng)的性能。與粒子計數(shù)器一樣，數(shù)據(jù)需要與時間和日期相關(guān)聯(lián)；需要長期備份或保存。此外，數(shù)據(jù)采集系統(tǒng)需要密碼控制。
Data integrityalso extends to good practices in relation to assessing critical cleanroomparameters, such as pressure, temperature and humidity. The failure toacknowledge and investigate alarms would, for instance, be raised as a dataintegrity citation by a regulator. Where there is no system in place forautomated data capture, other data integrity concerns, which link to ethicalbehavior to support GMP, would extend to overwriting of data; backdating ofrecords; ineligible data; failure to give data context in terms of date andtime; incomplete data; and to missing data.
數(shù)據(jù)完整性還延伸至與關(guān)鍵潔凈室參數(shù)(如壓差、溫度和濕度)的評估有關(guān)的良好實踐。例如，未對報警進行報告和調(diào)查可能會被監(jiān)管機構(gòu)作為數(shù)據(jù)完整性缺陷提出。在沒有自動數(shù)據(jù)采集系統(tǒng)時，其他用以支持GMP的道德行為問題，將延伸到數(shù)據(jù)覆蓋、倒簽記錄；錯誤數(shù)據(jù)；未能提供日期和時間方面的數(shù)據(jù)環(huán)境；數(shù)據(jù)不完整；以及數(shù)據(jù)缺失。
Other areaswhere verification is important relate to gown control. Where reusable gowns arein place, the supply chain needs to be controlled to ensure that gowns arecollected, washed, laundered and (if required) sterilized. Many facilities haverestrictions on the number of times that a gown can be used since the cycle oflaundering and sterilizing will, at some point, affect gown integrity. Whilethis can be recorded manually, a more secure and reliable way to control gownuse is through the use of barcodes.
其他重要的領(lǐng)域包括潔凈服控制。如潔凈服可重復使用，需要對供應鏈進行控制，以確潔凈服得到收集、清洗和(需要時)滅菌。許多工廠對潔凈服的使用次數(shù)有限制，因為清洗和滅菌的程序在某種程度上會影響潔凈服的完整性。雖然這可以手動記錄，但一個更安全和可靠的方式是通過使用條形碼。
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