實驗室審計追蹤具體包含哪些項目

實驗室審計追蹤具體包含哪些項目AuditTrails審計追蹤Anaudittrailisachronologyofthe“who,what,when,andwhy”ofarecord.Itensuresasecure,computer-generated,time-stampedelectronicrecordisavailablethatallowsforreconstructionofthecourseofeventsrelatingtothecreation,modification,ordeletionofanelectronicrecord.Forexample,theaudittrailforanHPLCruncouldincludetheusername,dateandtimeoftherun,integrationparametersused,anddetailsofreprocessing,ifany,includingthechangejustification.Inaddition,aspartofreconciliation,theinjectionlogcanbeincluded,butthisinjectionlogdoesnotincludeaudittrailinjectioninformation(blank/systemsuitability/Lot#)(2).審計追蹤是記錄“誰、做什么、何時、為什么”的記錄，能確保安全受控計算機所生成的，帶時間戳的電子記錄可以重建與電子記錄的創(chuàng)建、修改或刪除有關(guān)的事件過程。例如，HPLC運行的審計追蹤可以包括，用戶名，運行日期以及時間，所使用的完整參數(shù)記錄，再處理過程細節(jié)，或，修改理由。此外，進針日志也可囊括在內(nèi)，但是此進針日志不包括審計追蹤進樣信息(空白/系統(tǒng)適用性/批號)(2)。Theaudittrailfeature(orfunction)shouldbeenabledatalltimes,withstrictaccesscontrolsinplace;equipmentwithdataprocessingcapabilitybutlackingaudittrailcapabilityshouldbeupgradedtoCGMPstandards.Inthoseinstanceswheretheequipmentlackssuchcapability,appropriatecontrols(e.g.,paper-based)shouldbeimplementedtoensurealldataandinformationgenerated,alongwiththehistoryofallactivitiesperformed,isavailableforreview.審計追蹤功能應(yīng)始終啟用，并應(yīng)有嚴格的訪問控制，具有數(shù)據(jù)處理能力但缺乏審計追蹤功能的設(shè)備應(yīng)升級為cGMP標準。在設(shè)備缺乏該功能的情況下，應(yīng)實施適當?shù)目刂?例如，通過紙質(zhì)記錄)應(yīng)該被實施以確保所有數(shù)據(jù)和信息的產(chǎn)生，以及所有活動的歷史可以回顧。Theaudittrailshouldincludeallpossibledatachanges;then,thereviewercandecidewhetheranydatachangerepresentsacompromisedorregulatedevent.審計追蹤應(yīng)包括所有可能的數(shù)據(jù)更改；據(jù)此追蹤記錄，審閱者可以判別是否數(shù)據(jù)更改是否是一個異常事件。Differenttypesofaudittrailssupplydataondifferentfunctions;eachshouldbeassessedindividu-allyand,then,allaudittrailsshouldbeassessedcollectivelytodeterminetheintegrityofthedata.Instrument-specificsoftwareprovidesseveralfieldsforconfiguringaudittrails,andtemplatesfromwhichtochooseforpresentation.Figure6.3.9-1illustratesoneapproachtoaudittrailclassification.不同類型的審計追蹤提供不同功能的數(shù)據(jù)，每個都應(yīng)該單獨評估。然后，所

有的審計追蹤應(yīng)進行匯總評估，以確定數(shù)據(jù)的完整性。儀器軟件提供了用于配置審計追蹤的字段以及選擇用于表示的模板。圖6.3.9.1闡述了審計追蹤的一個分類方法SystemLev&l

系銃展面

Uaerscbvityflcgtn/togoffffailur&loginattempls/privtlegechanges)

用戶活動(登錄/登出/登錄失政/權(quán)限變化)

Systempolicychanges

系統(tǒng)策略變化ProdLKVMcleculeFoJderLovelApplicationLeveil施用展面產(chǎn)品/分子文件層囿序列，方法、域黑市廿追蹤的匯總Dataacquiredsyslerndetails數(shù)據(jù)捕集系琉的詳版情況Sequence序列Se^ueftcemodificationduringandaftercjxeculicm執(zhí)行過程中或執(zhí)行后的序列整改SurTirr^ryof窗鳥口口包『舊點、methods,resultaudittr^jlsCalculatedValue結(jié)果計算ProcessinghistoryProdLKVMcleculeFoJderLovelApplicationLeveil施用展面產(chǎn)品/分子文件層囿序列，方法、域黑市廿追蹤的匯總Dataacquiredsyslerndetails數(shù)據(jù)捕集系琉的詳版情況Sequence序列Se^ueftcemodificationduringandaftercjxeculicm執(zhí)行過程中或執(zhí)行后的序列整改SurTirr^ryof窗鳥口口包『舊點、methods,resultaudittr^jlsCalculatedValue結(jié)果計算Processinghistory(Int&grationtype,p§uitnumber,c^ilibr^tkHicurvesandmodificationofsampledetails),publiishingdetails處理歷史L積分類型『結(jié)果號.校正曲線和樣品信息的修改)，發(fā)布的具體情況Method方法Crealion/modtrie<ldetails創(chuàng)建、修改的詳細情況EachfnodlflcaUnnidentifiedbyversionnumber通過敝本號所識別的每一次修改Figure6.3.9-1ExampleofanAuditTrailSummary圖6.3.9-1審計追蹤示例TheQualityUnitisresponsibleforenablingfullyfunctionalaudittrails,assessingthedifferentkindsofmetadatacaptured,andchoosingwhichfieldsarerequiredtoverifyandensuredatareliabilityandcompliance.Thisapproachshouldbecarefullyselectedwithaviewtodesignthemostappropriatepro-ceduresforbatchreleaseaswellasasoundperiodicreview.Thefollowinglistreflectsonerecommendedapproachtothevariousclassificationsofaudits,eachofwhicharediscussedinthesectionsbelow:質(zhì)量部門負責啟用全面功能的審計追蹤，評估所捕獲的不同類型的元數(shù)據(jù)，并選擇哪些字段需要確認以確保數(shù)據(jù)的可靠性和完整性。應(yīng)仔細選擇此方法,以設(shè)計最適合批放行和定期審核的程序。對不同等級的審計追蹤的推薦方法如下所列：System-levelaudittrail系統(tǒng)層面審計追蹤Application-levelaudittrail應(yīng)用層面審計追蹤Methodaudittrail方法審計追蹤Resultsaudittrail(orinjectionaudittrail)結(jié)果審計追蹤(或進針追蹤)Sequenceaudittrail序列審計追蹤Transactionlog/systemerrorlog色譜事件日志/系統(tǒng)錯誤日志System-LevelAuditTrail系統(tǒng)層面追蹤Ifasystem-levelauditcapabilityexists,theaudittrailshouldcapture,ataminimum:anyattempttologin,successfulorunsuccessful;ID,date,andtimeofeachloginattempt;dateandtimeofeachlog-off;deviceused;andfunction(s)performedwhileloggedin,i.e.,applicationsthattheuserattempted,successfullyorunsuccessfully,toperform,asshowninFigure6.3.9.1-1(2).如果存在系統(tǒng)層面的審計能力，審計追蹤最少應(yīng)捕捉：任何登錄嘗試、成功或不成功；嘗試登錄的ID、日期和時間；每次注銷的日期和時間；使用的設(shè)備；以及登錄時執(zhí)行的功能，例如用戶嘗試的應(yīng)用程序；成功或失敗。Systemaudittrailscovertheactivitiesrelatedtosystempolicychanges,useractivities(login,logoff,unauthorizedloginsanduserprivilegeschanges),changestoprojects(creating,deleting,modifyingandrestoring),verificationofprojectintegrityandchangestosystems.TheQualityUnitshouldreviewsystemaudittrailsonaperiodicbasisestablishedbythefirmforanytypeofdeletions.系統(tǒng)審計追蹤覆蓋了系統(tǒng)策略更改、用戶活動相關(guān)的活動(登錄、注銷、未經(jīng)授權(quán)的登錄和用戶權(quán)限更改，對項目的更改(創(chuàng)建、刪除、修改和恢復(fù))，證明項目的完整性和對系統(tǒng)的變更。質(zhì)量系統(tǒng)應(yīng)定期審核系統(tǒng)審計追蹤以確定任何類型的刪除。Figure6.3.9.1-2displaysatypicalsystemaudittrailforprojectdeletion.Systemaudittrailsarere-viewedininvestigationstochecktheloginandlogofftimesaswellasanysystem-basedinformationthatisnotcapturedonapplication-levelaudittrails(2).圖6.3.9.1-2展示了一個典型的系統(tǒng)層面項目刪除的審計追蹤。系統(tǒng)審核追蹤可以在調(diào)查過程查看以檢查登錄和注銷時間,以及在應(yīng)用級別審計追蹤(2)中未能捕獲的任何基于系統(tǒng)的信息。

LoggedinasQAReviewerRterdilViewRecordsHp(pActionChangeDateUser1SuccessfullyLaggedOn3/22^01810?41:17AMEDT(□roupleaderUnsmceisfulLogonAitempt3/22/201010:42252AMEDTAnalystAsSuccessfullyLaggedOn3/23/201810^6AMEDTChemist4UnsucesssFulAnempttoConfirmIdentity3/22/20181。輯5位AMEDIGroupleatkr5UnsuccesslFullLoganAlt2mpit3/22/20181105503AMEOTAnalystA6UnsuccessfulLogonAttemptJ^2/2O1811^5:15AMEDTMaly5tA7UnsucceufutLogonAttempt1^22^01811305^8AMEDFAnalystA8SucressfuilyLoggedOn3^22/2010112028AMEDTChemistgSuccessfujlyLoggedOn^22^01811:31503AMEDTChwnisi10UnsuccMsfulAttempttoConfirmIdentity三<22/2018112168AMEOTChemist11SuccessfullyLoggedOnJf22?711:3WAMEDTCrouplwd^rFigure6.3.9.1-1SystemAuditTrail(Default)圖6.2.9.1-1系統(tǒng)審計追蹤Loggedin耕QAReviewer 二同RieEdktViewRecoidsHek>ActionChangeDateUser105DeletedProject4/14/2Q18 PMEDI&ymem/Admiini式iQto『ProjectXYZReasonsPrt>)ect也beingddeletl106107DeletedProject3/22/201BKH4252AMELJTSystem/AdministratorProjectAAARmsoitProjectisbeingdeleted.DeletedProject3722/201B1W56AMECFTSystem/AdministratorProjectKDReawn：Projeclisbeingdeleted.108DetetedProject3/22/201Blft4SB2AMEOTSystem/AdministratorProjectHGKReason：Prp|ectisbeingdeleted.109DelatedProjed3/22/201BllflSUBAMEIJTSystem/AdmiinistrAtorProjectDDfiReas4xi:Projectisbeingd@etedlFigure6.3.9.1-2SystemAuditTrailforProjectDeletion圖6.3.9.1-2項目刪除的系統(tǒng)審計追蹤Application-LevelAuditTrail應(yīng)用層面審計追蹤Application-levelaudittrailsmonitorandloguseractivities,includingwhichdatafileswereopenedandclosed,andwhatspecificactionshavebeentaken,suchasreading,editing,processing,anddelet-ingrecordsorfields,andpublishingreports.Thiscouldalsobecalledaproject-levelaudittrail.Someapplicationsmaybesensitiveenoughtocreateanaudittrailthatcaptures“before”and“after”informa-tionforeachmodifiedrecordorthedatachangedwithinarecord(54).應(yīng)用層面審計追蹤監(jiān)視和記錄用戶活動，包括打開關(guān)閉哪些數(shù)據(jù)文件，以及采取了什么具體行動，例如查看、編輯、處理和刪除記錄或文件，和發(fā)布報告。這也可以稱為項目級別審計追蹤。某些應(yīng)用程序可能足夠敏感,可以創(chuàng)建一個審核追蹤,用于捕獲每個修改記錄的"之前"和"之后"信息,或記錄中更改的數(shù)據(jù)(54)。MethodAuditTrail方法審計追蹤Methodaudittrailstrackthechangesmadetothemethodandtypicallycontainthefollowinginformation:方法審計追蹤追蹤方法所做的更改，通常包含以下信息：Methodmodificationhistory方法修改歷史Methodusedforallinjections所有進樣的方法Methodmodifiedbetweenthesequences不同序列之間的方法修改ResultsAuditTrail結(jié)果審計追蹤Chromatogramsorreportscanserveasaresultsaudittrail.Figure6.3.9.4-1isamodelresultsaudittrailreportthatpresentsintegrationtype,dateacquired,dateprocessedandbywhom,andifthechro-matogramwasalteredaftergeneratingdata.Typically,chromatogramsshouldcontain:色譜圖或報告提供結(jié)果審計追蹤。圖6.3.9.4.1是一個結(jié)果審計追蹤報告模板，它顯示了積分類型、獲取的日期、處理的日期以及由誰處理的日期，以及在生成數(shù)據(jù)之后色譜圖是否被改變。色譜圖通常應(yīng)包含：Sampledescription樣品描述Dateandtimeofsampleacquisition樣品采集的日期和時間Dateandtimeofresultsprocessed,ifpossible處理結(jié)果的日期和時間(如有)Minimummethodparameters,i.e.,wavelength,injectionvolume,andmethodname/ID方法參數(shù)，比如波長、進樣量、方法名稱/IDIntegrationtype積分類型Retentiontime(anyothersystemsuitparameters)保留時間Timeprinted,published,orsaved打印、發(fā)布或保存時間Integrationevents積分事件Samplenamechangeafterexecution執(zhí)行后樣品名稱變更Filterscanalsobeusedtosearchtherequirementfromhugeamountsofdata.Figure6.3.9.4-2rep-resentsafiltertosearchwhetherthesamplehasbeeninjectedinmultipleprojects.Foroldersystemswithlimitedfunctionality,thereviewershouldsignandstampresultsprintedonpaperandreviewtheelectronicdataaccordingtotheQualityUnitpolicy.Iftheresultsarepublishedelectronically,there-viewershoulde-signtheresultsafterreviewingandlockthesignedfile.Ifitwillbeusedforanyinves-tigationalpurpose,theQualityUnitmustreviewtheelectronicdataperthefirm’spolicy,aselectronicdataisdeemedtobefinal.Oncetheprinteddataisaudited,originalelectronicdatashouldbeavailableforreferenceandshouldnotbealtered.Anymodificationtotheapproveddataneedstobejustified.篩選器還可以用于從大量數(shù)據(jù)中搜索所需信息。圖6.3.9.4-2代表篩選器搜索在多個項目中的樣品進樣。對于舊系統(tǒng)在功能有限的情況下，復(fù)核人應(yīng)在打印結(jié)果上簽名并按照質(zhì)量部門SOP復(fù)核電子數(shù)據(jù)。如果結(jié)果是以電子形式發(fā)布的，復(fù)核人在審核后對結(jié)果進行電子簽名并鎖定名文件。如果它將被用于任何調(diào)查目的，當電子數(shù)據(jù)被認為是最終的數(shù)據(jù)，質(zhì)量部門必須按照公司的政策審查電子數(shù)據(jù)。一旦打印的數(shù)據(jù)被審核過，原始電子數(shù)據(jù)應(yīng)該僅用于參考，不可更改。對批準的數(shù)據(jù)的任何修改都應(yīng)進行論證。5amp居5獻MNhndReportSummarysampleSett^meQCEJ6ao_(?7_lrj SampieSetId3794Lmeaity_SSMPeakResultsSampfeMameVUI白ALqulredinslrumeniMetlitidIdUseriBlart(Mub41ePhd^)12/3/201711:2234AM1ST1m3匚hem聞2Caffeine(0.06mg/rnU_5|jL22/3/201711:26:13AM：EST1003Chemist3Caff?re(a06mgi/mU_20nl22/3/3017114*56AMESTI0CJ1Chwriist4Caffeine(0.06Fna/mlj.WL22^/201711:1551AM的1003ChenlstSCaffeine也加irig/iirilJ_90|jL22/3/201 AMHIIMSChemist6Caffeine(0.06mg/mU_1OOyL2W2O1711:4221AMEST1003ClteinKtPeakResultsR?ulrComment5;AltWfHlRpsultl1nj&ctk)nID□ateAcquiredResult口1Pidc?5InjpctionNd1J78￡2Z3/X3171M539PMEST3S312Pkk?bInjectionIMO137912/3/201/12:15卻PME513S223Pioc四舊型clknNd117982/3/201712J53WPME5T38234PiucmsInjecltonNd138042G/201713:T5?*lPMEST3624￡P(guān)idtmaInjprlionNd113810J/3/20171?!ISrtlPMEST招6PioceuInjectionNo138)52/3/201712;T&^2PMEST3826'specrticHesurtnumberEtenotesmnplenarrnealleMtlon(■詫Lifnamealtered)ResultsAuditTrailReport圖6.3.9.4-1結(jié)果審計追蹤報告Figure6.3.9.4-2FiltertoSearchSampleinMultipleProjects圖6.3.9.4-2使用篩選器在多個項目中尋找樣品SequenceAuditTrail序列審計追蹤Sequenceaudittrails,orsamplesetaudittrails,trackthechangesmadetothesamplesequenceorbatch.Figure6.3.9.5-1representsatypicalsequenceaudittrailreport,whichgenerallycontainsthefollowinginformation:序列審計追蹤或樣品集審計追蹤，追蹤對樣品序列或批所做的更改。圖6.3.9.5-1表示典型的序列審計追蹤報告，一般包含以下信息：Namecorrectionforsamplesetorinjectionsafterinjectionacquisition樣品采集或進樣名稱改變Samplesetalteration樣品集改變Samplenamealterationduringsequenceexecution在序列執(zhí)行過程中更改樣品名稱Methodusedforallinjections用于所有進樣的方法Abortedsequences取消序列Project-LevelAuditTrail項目審計追蹤Byenablingtheaudittrailsoptionwhilecreatingit,aprojectwillcapturealltheactivitiesperformedwithrespecttosampleset,injections,channels,results,calibrationcurves,andpeaks.Figure6.3.9.6-1representsaprojectaudittrailrecordfordeletedinjectionasapoorexampletoshowfraudulentdata.通過啟用審計追蹤選項時可以激活，項目將捕獲關(guān)于樣本集、進樣、通道、結(jié)果、校準曲線和峰執(zhí)行的所有活動。圖6.3.9.6-1顯示了項目審計追蹤記錄一個刪除的事件，來展現(xiàn)欺詐性數(shù)據(jù)的示例。Action1RwSampleSetDeU451七期漫犯:值_枷_咖」4L崛闔L知*Saq觸細以祗唯一曲JM，」WLhHrM_3SMym（電調(diào)lot?剛觸sor姐:映小蛇ikeChanq?DaleUserMise12^dnUt1J1：niM￡HUHIKIQQ_680SampleSetAuditTrailReport圖6.3.9.5-1樣品設(shè)置審計追蹤報告DCOMS1OiMMbjtgSanpieHuntCJflEw?iuttM1.Oitg/mkfiTdtectWatlERM防總電艇科《后便愜碩ChMigeguUMf12^30018S2H1PMBT消iftnProjectAuditTrail-DeletedInjection圖6.3.9.6-1項目審計追蹤-刪除進樣InjectionLog進樣日志Chromatographicdataacquisitionsoftwaretypicallyhastheabilitytomaintainalogofinjections.Inadditiontothedateandtime,thesoftwaremayincludeadditionalinformationassociatedwiththeinjectionsuchaslotnumber,blankorsystemsuitability,reference,orsample.Anaudittrailensurestheintegrityofthedataand,iftheaudittrailisenabled,reviewoftheinjectionlogisnotnecessary.Injectionlogreportsaretypicallybuiltinbythesoftwaredeveloper,thoughwithlimitedabilitytocustomizewithoutexpertprogrammingcapability.Thetype,easeoflogretrieval,andeaseofprinting/publishingarealsobuilt-infunctionalitiesofthesoftware;however,theirinclusionwillvaryamongsoftwaresuppliers.Aninjectionlogisseparateanddistinctfromanaudittrail;whileitisagoodtooltohave,itisnotessentialtoensuringdataintegrity(2).色譜數(shù)據(jù)采集軟件通常具有保存進樣日志的功能。除日期和時間外,軟件還可能包括與進樣相關(guān)的附加信息,如批號、空白或系統(tǒng)適用性、對照或樣品。審計追蹤可確保數(shù)據(jù)的完整性,如果啟用了審計追蹤,則不需要檢查進樣日志。進樣日志報告通常由軟件開發(fā)人員構(gòu)建,因此沒有專家編程能力，自定義能力有限。軟件還內(nèi)置功能,便于日志檢索,易于打印/發(fā)布;但是,不同軟件供應(yīng)商的內(nèi)容會有所不同。進樣日志是獨立的,有別于審計追蹤，盡管這是一個很好的工具,但對確保數(shù)據(jù)完整性(2)來說并不重要。TransactionalLog/SystemErrors事件日志/系統(tǒng)錯誤Chromatography色譜儀Thetransactionallog(whichmaybereferredtobyothertermsdependingontheequipmentvendor)andsystemerrorlogsareonline,instantaneousfeaturesthatdisplaypop-upmessagesaboutsystemfunctionality,useractivity,andhardware-relatedissuesorerrors.Figure6.3.10.1-1showsthetypesoferrorsgeneratedbythesoftwareortransactionallogandatypicalrepresentationofasoftwaretransac-tionallog.Figure6.3.10.1-2representsatypicaltransactionalerrorlog.事件日志和系統(tǒng)錯誤日志(根據(jù)設(shè)備供應(yīng)商的不同，此術(shù)語可以用其他術(shù)語來指代)是實時的、即時的特性，它們顯示關(guān)于系統(tǒng)功能、用戶活動和硬件相關(guān)問題或錯誤的彈出消息。圖6.3.10.1-1、6.3.10.1-2展示常見錯誤。Thetransactionallogisneitheranaudittrailnorisitintendedtobeareplacementfororcomponentofotheraudittrails.Atransactionalloggenerallyprovidessomeadditionalinformationrelatedtosoft-ware(e.g.,missingvial,lostprime)orhardwaremalfunctions(e.g.,HSSfault,lostconnection)andcanhelpininterpretingtheaudittrail.事件日志既不是審計追蹤，也不作為其他審計追蹤的替代或組成。事務(wù)日志提供與軟件有關(guān)的額外信息(如，missingvial,lostprime)或硬件功能異常(如HSS錯誤，斷開連接)以及可以幫助解釋審計追蹤。Nooneshouldhaveaccessorauthoritytomanuallychangethislog;however,thesystemcanbeconfiguredtoautomaticallypurgethemessagesonaperiodicbasistoensureefficientoperationofthesystemprocess-ingmemory.Iftheaudittrailisneverturnedoff,anydeletion,modification,orcopyingofmessagesper-formedbytheadministratorwillberecordedinvalidatedaudittrails(e.g.,systemaudittrail).TheQualityUnitshouldverifywhenasystemorrunhasbeeninterruptedduetoadisconnectionorpowerloss.不應(yīng)有人有權(quán)限修改此日志。然而，可以將系統(tǒng)配置為定期自動清除信息，來保證系統(tǒng)充足的操作記憶內(nèi)存。如果審計追蹤功能從未關(guān)閉，那么管理員說執(zhí)行的任何有關(guān)信息刪除、修改、和拷貝都會被記錄在經(jīng)驗證的審計追蹤中(例系統(tǒng)審計追蹤)。質(zhì)量部門應(yīng)確認系統(tǒng)或一次運行何時于斷開連接或斷電造成的中斷。lyoesteoorynmeAppucauonimProgftiw*粼即療MRMUST迎網(wǎng)SwtaKterFMCWt?Mk￥L加7Error/nsfnifrenF1/1第加及rtMEJTQCL56SGroupteoder械亡&伽砒￥L蜀療Messageprimpin由啪既KroftjreW2690/StDlISM7731AFigure6.3.10.1-1ExampleofaTransactionalLog圖6.3.10.1-1事件日志示例n/ie/20180903：14pColumnheaterdooropen11/19/201805:26心4PBubblefoundonaxnpression11Z20/20181227：47pColumnheaterdooropen09:41:5%Rubblefoundoncompression11/27/20181035:43aColumnheaterdooropen■11Z27/20181037:11aColumnheaterdooropen■11/27/2018112957aColumnbeaterdooropen11/27/2018113631aColumnheaterdooropen11/27/20181137rf)3aColumnheaterdooropenErrorLogIdleExampleofaSystemErrorLog圖6.3.10.1-2系統(tǒng)錯誤日志示例Themessagesappearinginthelogmaycomefromtheapplicationsoftware,third-partysoftware,(e.g.,Oracledatabasesupportingsystemforchromatographicsoftware)orotherconnectedinstruments(e.g.,balanceconnectedtoHPLC)orequipment.Somechromatographicsoftwarepackagesofferthisfunction-ality.Thetransactionallogsaresystem-levelmessages,temporarilystoredandoftenautomaticallypurgedbythesystemattime-baseddefinedintervals;theirutilityisthereforetime-sensitive.Thesetransactionallogsmayprovebeneficialfortrending(e.g.,trendingofmostfrequentinstrumentorprocessingerrorsthatrequireattentionhelpsintroubleshooting)orinvestigationalpurposes(e.g.,describingthecauseofthefailure)andcompaniesmayutilizethisinformationaccordingly.Duringsoftwarevalidation,messageswillpresentasinformation,warning,orerroraccordingtolistedcategories(e.g.,general,security).Criticalmessagesandactionsregardingdatamanipulationordatadeletionthatmayappearinthetransactionallogmustbecapturedinvalidatedaudittrails(e.g.,system,result,sequenceorsample,ormethodaudittrails).日志中出現(xiàn)的消息可能來自應(yīng)用軟件、第三方軟件，例如支持色譜軟件系統(tǒng)的Oracle數(shù)據(jù)庫或其他連接儀器(例如連接到HPLC的天平)或設(shè)備。一些色譜軟件包提供了這種功能。事件日志是系統(tǒng)層面的信息，臨時存儲并以指定時間間隔自動清除；因此它們的實用性是有時間限制的。這些日志對于分析趨勢(例如，分析需要關(guān)注幫助排除故障的最頻繁使用的儀器或處理錯誤)或調(diào)查原因(描述失敗原因)可能有好處，公司可以相應(yīng)的利用這些信息。在軟件驗證期間,信息將根據(jù)列出的類別(例如,常規(guī)、安全性)顯示為信息、警告或錯誤。在事件日志中可能出現(xiàn)的關(guān)于數(shù)據(jù)操作或數(shù)據(jù)刪除的關(guān)鍵消息和操作必須在經(jīng)過驗證的審計追蹤(例如，系統(tǒng)、結(jié)果、序列或示例，或方法審計追蹤)中捕獲。Categorizationoferrormessageshavinganimpactonthesoftwareandproductideallywouldbeincor-poratedduringsoftwaredevelopmentandvalidationbythevendor.Someerrorswithtitlesthatsoundcritical(e.g.,cabledisconnected,connectionlost,communicationfailure）maynotbecapturedinavalidatedaudittrailbutrecordedinatransactionallog.Itmaybedifficulttoconfirmthatthesetypesofmessagesareallcausedbyintentionalinterruptionsorhaveanyimpactonproductqualitydata.Itisthereforeimportanttohaveappropriatecontrolsandproceduresinplacetoensurethattruepoweroutagesberecorded,especiallyifachromatographicrunisaffected.理想情況下，對軟件和產(chǎn)品有影響的錯誤消息的分類將在軟件開發(fā)和供應(yīng)商驗證期間涵蓋。一些標題聽起來很關(guān)鍵的錯誤（例如，電纜斷開、連接丟失、通信失敗）可能不會在經(jīng)過驗證的審計追蹤中捕獲，而是記錄在事件日志中。可能很難確認這些類型的消息都是由故意中斷引起的，或?qū)Ξa(chǎn)品質(zhì)量數(shù)據(jù)有任何影響。因此有必要建立適當?shù)目刂坪统绦?，以確保真正的停電記錄，特別是如果色譜運行受到影響。TheQualityUnitforthelabmustestablishandvalidateerrormessagesduringequipmentinstallationandqualification.Someerrormessagesarespecifictotheoperatingsystemofthesoftwareandarenotdirectlyrelatedtodataorequipmentoperation.Itisimportanttoworkwiththesoftwaresuppliertounderstandthedescriptionofmessagesthatarerecordedinthetransactionallogastheymaybesubjecttoevaluationduringinspection.Further,itisimportanttoidentifythosemessagesthatarecritical,i.e.,relatedtodataandinstrumentoperations.Forexistingorpreviouslyinstalledequipment（e.g.,legacysystems）,duringinstallationandqualification,theQualityUnitshouldassurethatalltransactionallogmessagesarereviewedandunderstood,andthatcriticalmessagesareidentifiedandincludedinvalidatedaudittrails.Transactionallogmessagesthathavenoimpactonanalysesorqualityattributesofaproductandmessagesthatarealsorecordedinvalidatedaudittrailsneednotberetained.實驗室的質(zhì)量部門必須在設(shè)備安裝和驗證期間建立和驗證錯誤信息。一些錯誤消息是特定于軟件的操作系統(tǒng)的，與數(shù)據(jù)或設(shè)備操作沒有直接關(guān)系。與軟件供應(yīng)商一起工作以理解記錄在事件日志中的消息的描述是很重要的，因為它們可能在檢查期間受到評估。此外，重要的是識別那些關(guān)鍵的消息，即與數(shù)據(jù)和儀器操作有關(guān)的消息。對于現(xiàn)有或先前安裝的設(shè)備（例如，遺留系統(tǒng)），在安裝和驗證期間，質(zhì)量部門應(yīng)確保審查和理解所有事件性日志消息，并確保在已驗證的審計追蹤中識別關(guān)鍵消息。不需要保留不影響產(chǎn)品分析或質(zhì)量屬性的事件日志消息以及也記錄在已驗證的審計追蹤中的消息。Forexample,ifacableisdisconnectedfromanHPLCtoaLAC/Ebox,thenthedatawillnotbecaptured,andthetransactionallogwillshowamessageassysteminterruptionduetocabledisconnection.Furtherdia-loguebetweenindustry,healthauthorities,andvendorsisneededtoresolvehowtoaddressthisevolvingtopic.例如，如果從HPLC到LAC/EBOX的連接斷開，那么數(shù)據(jù)將不被捕獲，并且事件日志將顯示消息為由于連接斷開導(dǎo)致的系統(tǒng)中斷。需要在行業(yè)、衛(wèi)生部門和供應(yīng)商之間進一步對話,以解決如何處理這個不斷變化的話題。OtherTypesofEquipment其他類型的設(shè)備TransactionallogsarealsoavailablefromothertypesofautomatedanalyticalequipmentsuchasX-raydiffraction(XRD)orKarlFisher(KF).ExamplesareshowninFigure6.3.10.2-1andFigure6.3.10.2-2below.Figure6.3.10.2-2alsoprovidesanexampleofhowthelogentriescanbemisleadingifanauditorisnotfullytrainedonthesystem.Forexample,althoughoneentryreads“Deletedthejournalentry”intheXRDlog,theactualreasonfordisplayingthemessageisajobinterruption.TheQualityUnitshouldrec-ognizecriticalmessagesrecordedintransactionallogsandensuretheyarerecordedinvalidatedaudittrails.其他類型的自動化分析設(shè)備也有事件日志，如X射線衍射(XRD)或水分儀(KF)。如圖6.3.10.2-1和6.3.10.2-2所示.圖6.3.10.2-2還說明如果審核人員沒有對系統(tǒng)進行全面培訓(xùn)，則日志條目可能產(chǎn)生誤導(dǎo)。例子在以下圖6.3.10.2.1-6.3.10.2.2展示。例如，雖然一個條目在XRD日志中讀取"刪除日志條目",但顯示消息的實際原因是作業(yè)中斷。質(zhì)量部門應(yīng)該識別記錄在事件日志中的關(g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SutterkjadingaKembMWlzar(JPljglExfemionXid.FeisiwiV占JuOKulture=nE?twLPuMIcKeyTblffin=n5lExampleofaTransactionalLogforXRD圖6.3.10.2-1XRD事件日志示例Warning20^7-?227JM:WUIC4KF3GMdrtionlrLgstoppedinFdmuTion刈7g2213D3JIUTC4KF2D^T9nniiUTkKinnish&dWarning20173221103:17UTC4KF1Condttianlnq5topp?dInfbnnatiafi2017^0922IK)至10W匚4KHDeterminationfinishedVfamlna2017?22BO2^7UFC-4KF2Sam^e6ai3livemodifiedInftxmation2017-09-221351JSUTC^KF2DetemnlnatbonstartedWarning20^7092?BOOJ7LffC4KF1Sdmpie胡alivemodifiedlmfwmat>on2017gAi2:5441LffC-4KF1DetenninatkmstartedFigure6.3.10.2-2ExampleofaTransactionalLogforKF圖6.3.10.2-2KF事件日志示例CommonDeficiencies常見缺陷Thefollowingproblems,listedwiththerespectiveALCScomponents,areoftenencounteredandcom-monlyfoundinauditsorcitedinFDAWarningLetters:(55)FDA警告信中關(guān)于復(fù)雜計算機化系統(tǒng)的數(shù)據(jù)完整性的常見典型缺陷如下:Computers計算機Sharedpasswords共享密碼Nocontroloverdatagenerated未控制所生成的數(shù)據(jù)Dataacquisitiondate-and-time-stampchangestoalteractualdateandtimeofresults修改數(shù)據(jù)采集日期和時間戳以改變實際的結(jié)果日期和時間Nocontrolofautomaticsoftwareupdates軟件自動更新沒有控制Computersystems/softwarevalidationerrors計算機系統(tǒng)/軟件驗證錯誤Timesynchronizationacrossallequipmentandcomputersinthelaboratory實驗室內(nèi)所有設(shè)備和計算機的