洁净室环境监测中的数据完整性问题

洁净室环境监测中的数据完整性问题本文摘自电子期刊，适用于在线粒子系统和便携式粒子计数器PDAWhen carryingout reviewsof particlecountersfive generaland importantdata integrityquestionsare:当进行粒子计数器的审查时，有个常见和重要的数据完整性问题5Is electronicdata available是否有电子数据？Is electronicdata reviewed是否对电子数据进行审核？Is metadata audittrails reviewedregularly元数据审计追踪是否定期审核？Are thereclear segregationofduties是否有明确的职责分工？Has thesystem beenvalidated foritsintended use系统的预期用途是否经过验证？To addto theabove,ensuring thatthe counterhas beencalibrated by a competentperson anditsopticalsensors arefree fromcontamination,enable the data collectedtobe reliableandrepresentative of the cleanroomenvironment.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 additiontothese broaderquestions,individual particle counters shouldbe assessedagainstregulatorydata integrityexpectations.The typesof dataintegrityissues whichcan impactupon aparticle counter,and thuswhich needanassessment,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 ofdefinitions of data,leadingto incorrectrecord storage.This canarise ifpersonnel areunawareof whattheraw dataand theoriginal recordare such as a print-out ora pdfofparticle data,what comprisesa completerecord.The definitionof datashouldbe captured in aprocedure.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pdf述数据的界定

2.System access.Particle countersshouldrequire passwordaccess,with eachuser havingaunique password.Thisensures thateach particle counting eventis tiedto aspecific user,withdateand timeinformation additionallycaptured.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 ofcontrol.The particlecountershould comeequipped withdifferent levelsofaccess.This wouldinclude,as aminimum,a basicuser,who canturn the counter onand off;asupervisor level,who canchange locationsettings andreview audittrails;andan administratorwhocan changelimits ordelete dataor clearbuffers.Theadministrator istypically someoneindependentof the users,as requiredindata integrityguidance,and ideallyindependent ofthe departmentswhouse theparticlecounter.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 controloflocation settings,technology isavailable forremote particlecounters wherethelocationidentification isembedded ina locationmounting bracketratherthan the particlecounter,which ismore reliablefor trendinga givenlocationof thelevel ofairborne particlesat aspecifiedposition inthe 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 passwordsand accesslevels,each instrumentis expectedto havean approvedlistof usersalongwith theirjob titles.As peopleleave anorganization,their username andpasswordneedto beremoved fromthe counterand theuser listupdated 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 datais capturedintemporary files.Unless particlecounters areconnectedto afacilitiesmanagement system,the long-term storageoftheraw datais notpossiblesincea typicalportable particlecounter willonly holda bufferofa setnumber of data pointsand oncethebuffer isfull the data isoverwritten.This meansdata must be printed-out ortransferred atregularintervalsin orderto preventdata 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 followson fromdatacapture.This concernsthe abilitytoretrospectively retrievedata aftera particlecountingsession andthis isagain linkedto theability toretrievestoreddata,which willbe limitedbythebuffer overwritingand the inabilityto storedata inanelectronic formatfor longperiods oftime withoutremovingthat datato asecondary sourceorturning thatdata intoa recordprint-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pdfWhere datacanbe producedas aportable documentfile ratherthan as aprint-out,this addsgreatersecurity.The pdfcannot beadjusted,and thepaper isless likelytofade.With theprint-out,this isoftenon thermalpaper,which isprone tofading.Where afacilities monitoringsystem isused thisw川bring withitsimilar dataintegrity concernsas withaparticlecounter.However thedata iscapturedelectronicallyleading tofewer touchpoints/compared withthestandalone counterwhere datatypicallyhas to be transcribedor enteredinto adatabase.Each dataentry isa stepwhere errorcanoccur.Toovercome this,some particlecounters havethe functionalityfor datatransmissionwheredata istransmitted viawired orwireless ethernetto asecureserver wheretheuserkeeps thefinalrecords.This formof datatransfercan proveto berobust providedthe processof datatransfer hasbeenqualified.如数据可以生成文件而不是打印文件，将增加更大的安全性文档不能修改，也不太PDF PDF可能褪色而打印，往往是热敏纸，很容易褪色如果使用设施监测系统，这将带来与粒子计数器类似的数据完整性问题然而，数据是通过电子方式捕获的，因此与通常需要将数据转录或输入数据库的单机版计数器相比，“人工介入”更少每个数据输入都是可能发生错误的步骤为了解决这个问题，一些粒子计数器具有数据传输的功能，通过有线或无线以太网将数据传输到安全的服务器如果数据传输过程经过确认，这种形式的数据传输是可靠的

7.File deletioncan occurwhere rawdataand metadatadata aboutdata]such asthe timeofsampling aredeleted fromt hecounter beforethedatahas beenprinted-put ortransferred.Aneffective counterwill havedifferent levelsof passwordaccess,with datadeletiononly permittedbyan administrator.Furthermore,thecountershouldhave anelectronic audittrail inplace so that anydeletionofdataistraceable.原始数据和元数据“数据的数据”，如采样的时间在打印或传输之前，可能被删除一个有效的计数器将有不同的密码访问级别，只有管理员才允许删除数据此外，计数器应有电子审计追踪，以便追踪任何数据删除行为

8.System security.In relationto aparticlecounter thisrelates toaccess tothe clockandcalendar functions.Itshould notbe possiblefor theuser toalter thedate ortime,and suchpermissionshouldrest withthe administrator.Where thetime ischanged suchasswitching fromdaylight savingthismustbecapturedinthe audittrail.Not havingthe particlecounter clockin synchronicitywithreal timewouldresult intheinabilityto linkany significantparticlecountfluctuations withspecificevents.系统安全关于粒子计数器，这涉及到对时钟和日历功能的访问用户不应该可以更改日期或时间，这种权限应交由管理员当时间改变时例如切换夏令时，必须在审计追踪中捕捉到这一点粒子计数器时钟不“实时”同步将导致无法将任何重大粒子计数波动与特定事件联系起来

9.A furtherbest practiceelement ofdataintegrity iswhat todo duringa disaster.This canrangefrom asystematicfailure whereno datacan berecovered tofailure ofinstruments.Theexpectation isthat disasterscenarios aredocumented.While thisisunlikely togo intoa standardoperatingprocedure fora counterit mightbecaptured ina sitepolicy orposition paper.数据完整性的另一个最佳实践要素是在“灾难”期间应该做什么“灾难”可能是系统性故障，无法恢复数据，也可能是仪器故障我们的期望是，灾难预案形成文件虽然这不太可能成为一个计数器的标准操作程序，但它可能会被写入工厂的方针或立场文件洁净室操作的其他领域Other Areasof CleanroomOperationsThere areotherareas towhich dataintegrity canbe applied.These includethe systemsdesignedtomonitor cleanroomsfor pressuredifferentials.Such dataisrequired toassess thatthe pressuredifferentialbetween adjacentareas ofa differentcleanroom class,or in relationtoan airlock,havenot fallentoolow orgone negative,as wellas toassess trendssothatperformance oftheoverall aircontrolsystem canbe assessed.As withtheparticlecounter,thedata needs to betime anddaterelated;to bebacked-up orstored long-term.Inaddition,thedatacapture systemneedstobepassword controlled.还有其他适用数据完整性的领域包括用于监测洁净室压差的系统这些数据用于评估不同洁净级别的邻近区域之间的压差，或与气闸有关的压差，没有降得太低或变成负值，以及评估趋势，以便评估整个空调系统的性能与粒子计数器一样，数据需要与时间和日期相关联；需要长期备份或保存此外，数据采集系统需要密码控制Data integrityalsoextends togood practicesinrelationto assessingcritical cleanroomparameters,suchaspressure,temperature andhumidity.The failuretoacknowledge andinvestigate alarmswould,for instance,be raisedasadataintegrity citationbyaregulator.Where thereis nosystem inplaceforautomated datacapture,other dataintegrity concerns,which linkto ethicalbehaviortosupport GMRwould extendto overwritingofdata;backdating ofrecords;ineligible data;failure togivedata contextin termsof dateandtime;incomplete data;and tomissing data.数据完整性还延伸至与关键洁净室参数（如压差、温度和湿度）的评估有关的良好实践例如，未对报警进行报告和调查可能会被监管机构作为数据完整性缺陷提出在没有自动数据采集系统时，其他用以支持的道德行为问题，将延伸到数据覆盖、倒签记录；错误数据；未能GMP提供日期和时间方面的数据环境；数据不完整；以及数据缺失Other areaswhereverification isimportant relateto gowncontrol.Where reusablegowns areinplace,the supplychain needstobecontrolled toensure thatgowns arecollected,washed,laundered and（）if requiredsterilized.Many facilitieshaverestrictions onthe numberof timesthat agown canbeused sincethe cycleoflaundering andsterilizing will,at somepoint,affect gownintegrity.Whilethiscan berecorded manually,a moresecure andreliable wayto controlgownuse isthrough theuse ofbarcodes.其他重要的领域包括洁净服控制如洁净服可重复使用，需要对供应链进行控制，以确洁净服得到收集、清洗和（需要时）灭菌许多工厂对洁净服的使用次数有限制，因为清洗和灭菌的程序在某种程度上会影响洁净服的完整性虽然这可以手动记录，但一个更安全和可靠的方式是通过使用条形码。