委托生产的数字化偏差管理协同（Digital deviations Improving sponsor- CMO collaboration-附biophorum双语原文）

Digitaldeviations:Improvingsponsor—CMOcollaboration1.0Introduction

1.0引言1.1Deviationstoday

1.1当今的偏差管理现状Tomaintaincompliance,sponsorsandCMOsalikeareresponsibleforensuringthattheproductstheymanufactureareconsistentlyproduced.ThesearecontrolledbythequalitystandardsappropriatetotheirintendeduseandasrequiredbytheMarketingAuthorization,ClinicalTrialAuthorizationorproductspecification.

为持续保持合规，申办方与CMO均负有责任，确保所生产的产品始终符合与其预期用途相适应的质量标准，并满足上市许可（MA）、临床试验许可（CTA）或产品标准的规定。Thisresponsibilityincludesdeviationmanagement,i.e.,theprocessofidentifying,reporting,investigating,documenting,managingandapprovingunexpectedoccurrencesidentifiedduringaGMPactivity.

该责任涵盖偏差管理，即对在GMP活动中发现的非预期事件进行识别、报告、调查、记录、处理和最终批准的全过程。Theseeventsoccurwherethereisnodefinedproceduralresponseinplacetoassurequalityisnotimpacted.

当现有程序无法保证质量不受影响时，即视为发生偏差。TheCMOandsponsorunderstandtheimportanceofidentifyingandunderstandingdeviationsandwanttoresolvethemefficientlyandquicklytoensurepatientsafety.

CMO与申办方均深知识别并理解偏差的重要性，并期望高效、迅速地解决偏差，以保障患者安全。Itiscriticaltoapproachthisbusinessprocessasapartnershiptoexecuteiteffectivelyandasquicklyaspossible.

因此，必须以合作伙伴的方式推进该业务流程，方能实现高效、快速的执行。Ifnot,theoutcomeoftheinvestigationisatriskduetoconcernsofmisalignment,whichbreakdowntrustandconfidencewithintheCMOandsponsorrelationship.

否则，因双方步调不一，调查结果将存在风险，进而削弱CMO与申办方之间的信任与信心。Accountabilitymustbeaddressed,butitcannotbedoneattheriskofasoundinvestigationandresolution.

问责必须落实，但绝不得以牺牲调查与解决的科学性和完整性为代价。WhenadeviationisidentifiedattheCMO,itisdocumentedwithintheirqualitymanagementsystem(QMS).

当CMO发现偏差时，应首先在其质量管理系统（QMS）中进行记录。Basedonthelevelorimpactofthedeviationandthequalityagreementrequirements,theCMOwillnotifythesponsor(s)ofthedeviation.

CMO将依据偏差级别/影响程度以及质量协议要求，向相关申办方发出偏差通知。Thetimingofnotificationsharingisoneofthemostcriticalstepsinthedeviationprocess,astimelynotificationsdemonstrateaclear,compliantoversightandensureappropriateescalationandcontainmentcanbemade.

通知的时效性是偏差流程中最关键的步骤之一；及时的通知可体现清晰且合规的监管，并确保适当的升级与遏制措施得以实施。Inmostcases,thesponsor'sdeviationmanagementprocesswillrequiredocumentingtheCMO'sdeviationintothesponsor'sQMSviamanualentry.

多数情况下，申办方（委托方）的偏差管理流程需通过手工录入方式，将CMO的偏差记录导入本企业的QMS。Thedatashared,levelofdetailandfrequencyofsharinglackconsistencyandstandardizationwithinandacrossthesponsor/CMOpartnerships.

所共享数据的范围、详细程度及共享频率，在申办方（委托方）与CMO内部及彼此之间均缺乏一致性与标准化。Untilthemanualentryhasbeencompleted,deviationdataexistsinanunusableform.

在手工录入完成之前，偏差数据处于不可用的状态。Also,errorscanbeintroducedthroughmanualdataentry.

此外，手工录入可能引入错误。Thisconsumestimeandcandelaytheinvestigationandresolutionprocess.

这不仅耗时，还可能延误调查与解决进程。DeviationsthatoccurataCMOcanimpactmultipleproductstheymanufactureandoneormoreoftheirsponsororganizations.

CMO发生的偏差可能影响其生产的多个产品以及一个或多个申办方组织。CMOsmustquicklyassessandperformsufficientinvestigationstoenableappropriatenotificationstotheimpactedsponsororganizations.

CMO必须迅速评估并开展充分调查，以便向受影响的申办方发出适当通知。ThiscreatesdataintegrityandprivacychallengesfortheCMO.

这给CMO带来了数据完整性与隐私保护方面的挑战。Theymustmanageandsharetherequiredinformationwiththedifferentsponsorsinawaythatmaintainsandprotectsthesponsor'sintellectualproperty.

他们必须在管理与共享所需信息时，维护并保护各申办方的知识产权。TrackingthestatusofthedeviationprocessismanualandbecomeschallengingacrosstheCMOandsponsororganizationsduetomultipleemails,phonecallsandcopiesofinformationsharedbetweentheorganizations.

偏差流程的状态追踪依赖人工，因组织间频繁的邮件、电话及信息副本往来，在CMO与申办方之间变得尤为困难。1.2DISCOVisionandDPMMAlignment

1.2DISCO愿景与DPMM的协同TheDigitalPlantMaturityModel(DPMM)wasdevelopedbyBioPhorumITDigitalandDataPhorummembercompaniesandiswidelyusedacrosstheindustrytoassessplantmaturity,identifycapabilitiesneedingdevelopment,createstrategicplansandroadmaps,influencesuppliersanddevelophumanresourcescompetencyanddevelopmentframeworks.

数字工厂成熟度模型（DPMM）由BioPhorumIT数字与数据论坛成员公司共同制定，已在行业广泛应用，用于评估工厂成熟度、识别待发展能力、制定战略计划与路线图、影响供应商并构建人力资源能力框架。TheDPMMdescribesfivelevelsofmaturity:pre-digitalplant,digitalislands,connectedplant,predictiveplantandadaptiveplant.

DPMM将成熟度划分为五个层级：前数字化工厂、数字孤岛、互联工厂、预测工厂与自适应工厂。TheDPMMconcludesthatorganizationsrequiredigitization,commonprocessesacrossproductsandaggregateddatatomakepredictiveandadaptiveapproachespossible.

DPMM指出，企业必须通过数字化、跨产品的统一流程以及聚合数据，才能实现预测性与自适应的运营方式。InNovember2022,theBioPhorumITDigitalandDataDISCO(DigitalIntegrationofSponsorandContractOrganizations)workstreampublishedtheVisionfordigitalmaturityintheintegrationbetweenbiomanufacturersandpartnerorganizations.

2022年11月，BioPhorumIT数字与数据论坛的DISCO（申办方与合同组织数字化整合）工作组发布了《生物制造商与合作伙伴间数字化整合成熟度愿景》。Thispaperdefinesasimplematuritymodelforintegrationsbetweenorganizationsinthesupplychain(seeFigure1).

该白皮书为供应链上下游组织间的整合定义了一个简洁的成熟度模型（见图1）。

Atthetimeofwriting,theexchangeofmostdeviationinformationcouldbedescribedasapre-digitalormanualextract.

在撰写本文之时，大多数偏差信息的交换仍处于“前数字化”状态，或仅通过手工提取完成。Thisneedstochangetobringefficiencyandsustainabilitytotheindustry.

行业必须改变这一现状，以实现高效、可持续的偏差管理。Thetargetintegrationpatternsfordeviationsare4Auto-ingestor5Nearreal-time,asshowninFigure1;however,organizationsstillneedtosupportpartnerorganizationsatlowerlevelsofdigitalmaturity.

如图1所示，偏差管理的理想集成模式应为第4级“自动摄取”或第5级“近实时”；然而，企业仍需兼顾数字化成熟度较低的合作伙伴。Thevisionpaperalsooutlinestheneedtoaligninseverallayers:processandrequireddata,datastructure,informationcontainerandsecuretransport.

愿景白皮书进一步指出，必须在以下多个层面达成一致：业务流程与所需数据、数据结构、信息容器以及安全传输。AsFigure2shows,itiscommontohaveasystemforsendingorreceivingdata,i.e.,anintegrationplatformthatmaps,wrapsanddispatchesdatasecurely,withoutnecessarilychangingtheoperationalsystemsanddatastores.

如图2所示，通常需要一套收发数据的系统——即集成平台——负责数据的映射、封装与安全分发，而无需改动现有的运营系统及数据存储。Partnersneedtoagreeonthetouchpointsinthebusinessprocesswheredataisexchangedandthedatapointsthatarerequired.

合作伙伴必须就业务流程中数据交换的“触点”以及所需的数据项达成一致。

Severalkeyactionsarerequiredtosupportdigitaldeviationsthataredeliveredwithinthisdocument,includingestablishing:

本文提出的“数字化偏差”落地需完成若干关键行动，包括确立：FoundationalstandardsandexpectationsfordeviationdatathatsponsorsandCMOscansupportwithaminimumofeffort.

偏差数据的基础标准与期望，使申办方（委托方）与CMO能够以最小代价予以支持。Foundationalbusinessprocessessupportingdatastandardsandexpectations.

支撑数据标准与期望的基础业务流程。Commonlanguageandcategorizationusedforcriticality,levelofimpact,etc.,ofdeviationsacrosssponsorsandCMOs.

跨申办方（委托方）与CMO的偏差关键性、影响等级等通用语言与分类方法。Qualityagreementstandardsthatsupportasharedaccountabilitymodelandcommonoversightexpectations/responsibilitiestofosterthepartnershipmindsetrequiredforeffectivedeviationmanagement.

质量协议标准，用以支撑共同责任模型及统一的监管期望/职责，从而培育有效偏差管理所需的合作伙伴思维。2.0

Digitaldeviationmanagement

2.0

数字化偏差管理2.1

Digitaldeviationsdefined

2.1

数字化偏差定义Whileeachorganizationstrivesforaneffectiveandefficientpathtocompliancewitheachdeviation,everyorganizationhasitsowninterpretationoftheregulatoryrequirementsandexpectations.

虽然各组织都力求对每一项偏差采取高效且有效的合规路径，但每一家组织对法规要求和期望的解读各不相同。Thiscreatesasignificantchallengewhenestablishingthefoundationalstandardsandexpectationsthatarecriticalinsupportingdigitaldeviationmanagement.

这给建立支撑数字化偏差管理所需的基础标准和期望带来了重大挑战。ThestandardsandexpectationsmusthaveenoughdetailtoenableconsistencyacrosseachnetworkofsponsorsandCMOs,andbetweenthem.

这些标准和期望必须足够详细，以便在申办方（委托方）网络内部、CMO网络内部以及两者之间实现一致性。Ontheotherhand,therewillneedtobeflexibilitytosupporttheuniqueneedsofsponsorsandCMOs.

另一方面，标准又需具备灵活性，以满足申办方与CMO各自的独特需求。Theever-changingcompliancelandscapewillalsopresentchallengesinestablishingandmaintainingstandardsandexpectations,requiringastrongfoundationthatcanbeenhancedandrevisedtoaccommodatefutureneeds.

不断变化的合规环境亦会对建立和维护这些标准和期望带来挑战，因此需要一个可强化、可修订的坚实基础，以适应未来需求。Overall,theneedfordigitaldeviationsissignificant.

总体而言，对数字化偏差的需求极为迫切。Byleveragingthestandardsandexpectationsestablishedwithinthisdocumentfordeviationbusinessprocessesanddata,sponsorsandCMOscannotify,shareandexecutethedeviationmanagementprocessaseffectivelyandefficientlyaspossible.

通过利用本文档所确立的偏差业务流程与数据标准及期望，申办方（委托方）与CMO能够以尽可能高效的方式完成通知、共享并执行偏差管理流程。Thedirectbenefitsofdigitaldeviationmanagementfocusonreducingthetimespentonexecutingmanualstepsofthecurrentdeviationprocessesacrossbothorganizations(seeFigure3),allowingthattimetoberepurposedformorevalue-addedactions.

数字化偏差管理的直接益处在于减少两家组织在现有偏差流程中手动环节所耗费的时间（见图3），从而将节省下来的时间用于更具价值的活动。Also,digitaldeviationmanagementenablestheresolutionofdeviationsquickerandminimizesthepotentialdisruptiontothesupplychainofcriticalmedicinestopatients.

此外，数字化偏差管理还能加速偏差解决，最大限度降低对患者关键药品供应链的潜在干扰。Thereareindirectbenefits,suchaspromotingtransparencyandimprovedoversightthat,inturn,strengthenthesponsor/CMOrelationship.

间接益处包括提升透明度与监管水平，从而进一步加强申办方（委托方）与CMO之间的合作关系。Assupplychainneedscontinuetoimprovesponsor/CMOrelationships,theneedfordigitaldeviationswillincrease.

随着供应链需求对申办方（委托方）/CMO关系的持续优化，对数字化偏差的需求也将不断增长。

2.2Benefits

2.2收益Oneofthemostcriticalelementstobescrutinizedacrossthemanufactureofpharmaceuticalsisdivergencesfromastandardorexpectedvalue.

药品制造过程中最受关注的核心要素之一，就是与标准或预期值的偏离。Understandingandanalyzingdata,processesandoutcomesisessentialtodeterminingthepotentialimpactonthepatientandproduct.

必须通过数据分析、流程梳理与结果评估，才能判定偏差对患者和产品的潜在影响。Thisareaisoneofthehighestprioritiesindatasharing.

该领域是数据共享的重中之重。ItisintheinterestofboththeCMOandsponsortodetermineanypotentialriskorimpactduetoadeviation.

CMO与申办方均须识别偏差带来的任何潜在风险或影响，这是双方的共同利益所在。DrivingdownthetimeittakestocloseoutadeviationinboththeCMOandsponsorsystemswillimprovetheefficiencyofsupply,andtransparencyandalignmentofeventsandtheiroutcomesareessentialtoensuringthatwhatisproducedissafeandefficaciousforthepatient.

缩短CMO（委托方）与申办方系统内偏差的关闭周期，将提升供应效率；事件及其结果的透明与一致，是确保所生产药品对患者安全、有效的关键。Forthesereasons,thetimelysharingofinformationondeviationsisacentralelementofaqualityagreement.

因此，及时共享偏差信息是质量协议的核心要素。Thisisamatterofcompliance,demonstratingathoroughunderstandingandcontroloverthemanufacturingprocessfromboththeCMOandsponsor'sperspective.

这不仅是合规要求，更体现了CMO与申办方对制造过程的全面理解与掌控。Beyondthecomplianceexpectation,sponsorsandCMOshavesharedgoalswhenitcomestoexecutingdigitaldeviationmanagement.

除合规外，申办方与CMO在执行数字化偏差管理方面还拥有共同目标。Someofthebenefitsofdigitizingdeviationsinclude:

数字化偏差带来的部分收益包括：Improvedtransparencyforsponsors.

提升申办方（委托方）透明度。IfadeviationhappensattheCMO,theresponsibilityforinvestigatingandunderstandingwhathappenedlieswiththeCMO;thereforethetransparencybenefitisrealizedbythesponsor.

若偏差发生在CMO，调查与理解事件的责任由CMO承担，因而透明度收益直接体现在申办方（委托方）。Alsomeansearlierdetectionofmissinginformation,whichcanimprovethespeedofclosing-outdeviations.

还可提前发现缺失信息，从而加快偏差关闭速度。Reviewingtrendsorpatternsthatwillpreventdeviationscanleadtostrengthenedsponsor/CMOpartnerships.

通过回顾趋势或模式以预防偏差，可进一步巩固申办方（委托方）/CMO合作关系。Havingadigital,moredigestibleformatallowsorganizationstoanalyzeandcreateafullerpictureofopen/closeddeviations,etc.,allowingyoutomanageyourresourcesbasedonthepriorityofyourbatches.

数字化、易读的数据格式使组织能够全面分析已关闭/未关闭偏差等，从而按批次优先级调配资源。Thiscanalsoresultinfewerhumanerrorsandfasterhandlingastherearenomoreemails,onlinecollaborationsystemsnotificationsorpapersbeingcirculated.

同时减少人为错误并加速处理，因为无需再频繁发送邮件、系统通知或纸质文件。Reducedtime-to-batchdisposition,whichcanleadtoshorterend-to-endleadtimes.

缩短批次处置时间，进而压缩端到端交付周期。Shortleadtimesmeanareductioninsafetystockrequirements,asthesecalculationsaretraditionallybasedonleadtime.

交付周期缩短意味着安全库存需求下降，因为传统安全库存计算以交付周期为基础。Thischangereducessupplychainriskandinventorycostsand,overall,resultsinimprovedpatientsupply.

这一变化降低供应链风险与库存成本，最终提升患者用药供应保障。IncreasedrateofbatchapprovalsmeansearlierinvoicingandpaymenttotheCMO.

批次批准率提高，CMO可提前开票并收回款项。Asmoredataissharedandbecomesavailable,therearemoreopportunitiestoleverageadvancedtechnology—whetherthroughautomationorartificialintelligence—touncovernewinsightsthatwillenablebothsponsorsandCMOstoinnovateandacceleratethedata-drivenbusinessdecision-makingprocesses.

随着共享数据量的增加，企业可借助自动化或人工智能等先进技术挖掘新洞察，推动申办方与CMO共同创新，并加速数据驱动的业务决策流程。Ontopofthesesharedchallenges,CMOshaveuniquechallengesasmosttransactwithavarietyofsponsorsconcurrently.

除上述共同挑战外，CMO还面临独特难题：其通常同时与多家申办方开展业务。Adeviationcaninherentlyaffectmultiplesponsors.

一起偏差可能inherently（固有地）波及多家申办方（委托方）。StrictfiltercriteriamustbeestablishedwithinaCMO'slocalprocessesandsystemstopreventdataleakagetocompetingsponsors,whilesupportingfullvisibilityofthedeviation.

因此，CMO必须在本地流程与系统中设定严格的过滤规则，在防止敏感数据泄露给竞争申办方的同时，确保偏差信息的完整可见。ThisischallengingascertainfieldsintheCMOQMSareusedtoaggregatethefindingsandanalysisofthedeviation.

难点在于，CMOQMS中的某些字段用于汇总偏差的调查结果与分析结论。Beforeanelectronicexchangeofthisdata,itmustbeproperlysanitizedandcontextualizedforeachsponsorreceivingthedata.

在电子交换前，必须对接收方的每位申办方分别进行数据“脱敏”与上下文适配。ThepotentialimpactormisinterpretationofidentifiedrootcausesoftenleadstoarestrictiveapproachtoinformationsharingfromaCMO.

已识别根因的潜在影响或被误读的风险，常导致CMO采取保守的信息共享策略。Thisoftenprohibitstimelysharingofdeviationinformationuntilfullyreviewedandapprovedversionsareavailable.

这往往使得偏差信息只有在完全审核定稿后才能共享，从而延误了时效。ThisoftenhamperstheinputfromsponsorSMEs.

进而阻碍申办方主题专家（SME）及时介入提供输入。WhiletheCMOisresponsibleforthemanufacturingofthatproduct,theylikelywillnothavevisibilityontheprecedingorsubsequentmanufacturingstagesintheoverallsupplynetwork.

尽管CMO负责该产品生产，但其通常对整个供应网络中前后制造环节缺乏可见性。Thiscanbeofcriticalimportanceindeterminingtheoutcomeofaninvestigation.

而这一点可能对调查结论的判定至关重要。Thisconservativeapproachcanfurtherreducevisibilityintotheissuesthatariseduringthemanufacturing.

保守策略进一步降低了对制造过程中出现问题的可见性。BystrictlyadheringtotheQTAs,oftenwhataredeemedbytheCMOtobeminorortrivialdeviations,arenotvisibleuntiltheentirebatchfileissharedfollowingCMOrelease.

由于严格遵守质量技术协议（QTAs），那些被CMO视为轻微或琐碎的偏差，往往要等到CMO放行后、完整批档案被共享时才得以显现。AstheresponsibilitiesoftheCMOandsponsoroftendiffer,thesearereviewedpriortomarketrelease.

鉴于CMO与申办方职责常存在差异，此类偏差需在上市放行前接受复核。Questionsorconcernsthatariseduringthisperiodhaveadirectimpactonthepatientsupplyduetothelackofvisibilityovertheproceedingweeksormonths.

在此期间产生的疑问或关切，由于随后数周或数月内信息不透明，将直接影响患者用药供应。Whilemuchofthedeviationchallengesmentionedherearemutuallyshared,therearejustasmanychallengesspecifictotheCMOandsponsoralike.

尽管上述偏差挑战多为双方共有，但同样存在大量各自特有的难题。3.0

Howdowedigitizetheprocess?

3.0

我们如何将流程数字化？3.1

Datatransmissionalignment

3.1

数据传输对齐ThedigitalmaturityleveloftheCMOandsponsorwillaffectthetypeoftransactionandfileformattobeused.

CMO与申办方的数字化成熟度将决定所采用的交易类型与文件格式。Thelimitingfactorheresitswiththecompanywiththelowerlevelofmaturity,astheexchangeneedstobeinlinewiththislevel.

限制因素在于成熟度较低的一方，数据交换必须以该方的能力上限为准。Resultsofa2022internal,member-onlyDISCOsurveyindicatedindustryaspirationsforprocessingqualityinformationareatMaturityLevel3/4,i.e.,auto-extract/auto-ingestion,includingdeviations.

2022年DISCO内部成员调查显示，行业对质量信息处理的期望成熟度为第3/4级（自动提取/自动摄取），偏差信息亦包含在内。AlthoughorganizationsatlowermaturitylevelswillleveragePDFstoexchangedeviationinformation,theminimumrecommendedapproachforautomateddataingestionisaflatCSVformat.

成熟度较低的组织仍可沿用PDF交换偏差信息，但实现自动摄取的最低推荐格式为扁平CSV。Tobetterfacilitateingestionandaccommodateextendeddatasets,solutionsshoulduseastructureddataserializationformatsuchasXMLorJSON.

为进一步提升摄取效率并支持扩展数据集，应采用结构化序列化格式（XML或JSON）。Theapplicationprogramminginterface(API)shouldbepreciselydefinedusingOpenAPIorAsyncAPItofacilitateimplementationoncommonintegrationplatforms.

API须使用OpenAPI或AsyncAPI精确定义，以便在主流集成平台上快速落地。3.2

Validationconsiderations

3.2

验证考量Deviationsmanagementhelpsusunderstandhowanon-conformancethathasoccurredcanimpactproductquality.

偏差管理帮助我们了解已发生的不符合事件对产品质量的潜在影响。TheelectronicexchangesofdeviationdatabetweenthesponsorandCMO,outlinedinthedigitaldeviationmanagementprocess,supportthiscriticalqualitybusinessprocess.

数字化偏差管理流程中规定的申办方与CMO之间的偏差数据电子交换，正是支撑这一关键质量业务流程的基础。Eachorganizationmustperformtheappropriatevalidationactivitiesforthevalidationresponsibilitiestheyown,asoutlinedintheQualityAgreement.

各方须按照质量协议中划分的验证责任，执行相应的验证活动。Toexecutetheoutlinedresponsibilities,eachorganizationwillfollowitscomputersystemsqualityassurance(CSQA)policiesandprocedures.

为落实上述责任，各方将遵循自身的计算机系统质量保证（CSQA）政策与程序。TheQualityAgreementwillbeusedtoestablishalignmentontheextentofCSQApoliciesandprocedureswhensignificantdifferencesinapproachexistbetweenthesponsorandCMO.

当申办方与CMO的CSQA方法存在显著差异时，应以质量协议为基准，就各自CSQA政策的适用范围达成一致。3.3Industry-standardfieldsforinitialnotificationtransaction

3.3初始通知交易使用的行业标准字段Thissectioncoversthedatasettobeusedasastandardreferenceforthedeviationnotificationinthedigitaldeviationmanagementprocess.

本节列出数字化偏差管理流程中，偏差通知应采用的基准数据集。Recommendationstoconsider:

相关建议如下：Establishingfilteringcriteria:werecommendthattheCMOandsponsordiscussthenecessaryfilteringcriteriaupfront,suchasrelevantproductsorriskcategories,tolimittheamountofdatabeingsharedandtopreventdataleakage.建立过滤条件：建议CMO与申办方预先讨论必需的过滤条件（如相关产品或风险类别），以限制共享数据量并防止数据泄露。Choosingaprimarykey:giventhenatureofdeviationdataandthefrequencyofupdates,itcanbetrickytofindtheappropriateprimarykeythatservesasauniqueidentifieroftherecord,sowerecommendevaluatingacombinationoffieldsthatcanservethispurpose.选择主键：鉴于偏差数据特性及更新频率，单一字段往往难以充当唯一标识，建议评估多字段组合作为主键。Handlingchanges:themethodofhandlingmodificationstothedatawithintherecordsisuptothepartiesinvolved,astheunderlyingsystemsandinterfacesmightvary.Westronglyrecommendestablishingajointcenterofexcellencethatmeetsregularly(e.g.bi-monthlyorquarterly)toconductjointimpactassessmentsanddiscusspotential/upcomingchangesandothersignificanttopicsrelatedtodataexchangeandwaysofworking.

强烈建议成立联合卓越中心，定期（如双月或季度）召开例会，共同评估影响，讨论即将发生的变更及其他数据交换与协作相关的重要议题。处理变更：记录内数据的修改方式由双方自行约定，因其底层系统与接口可能存在差异。4Systemdesigndeltas:itisimportanttoacknowledgethatthefunctionaldesignofQMSswillvaryacrosstheindustryduetomultiplefactors.

4系统设计差异：必须承认，受多种因素影响，行业内的QMS功能设计存在差异。Assuch,identicallynameddataelementswillexistbetweenasponsor'sQMSandaCMO'sQMSandtherewillbemoredesignpermutations(e.g.differentdatafieldnamingconventionsthatareusedinthesamemanner)ineachsystem.

因此，申办方（委托方）QMS与CMOQMS之间会出现“同名不同义”的数据元素，且各系统的设计组合（例如同一用途却采用不同字段命名规范）更加多样。Furthermore,allpartiesinvolvedmustconductamoregranularjointanalysisofotherdesignelements,suchaspicklistvalues,toalignonthenextlevelmappingand/orapproach.

此外，双方还需对下拉值等其他设计要素进行更细粒度的联合分析，以就下一层映射匹配方案或实施方式达成一致。Forexample,datainonesystemmaybeastring/textfield,whilethesamefieldintheothersystemmaybeapicklistvalue.

举例：同一字段在A系统为字符串/文本型，在B系统却为下拉值。Picklistvaluesforthesamefieldinbothsystemsmayalsocarrydifferentvalues,e.g.aRiskCategoryfieldinonesystemmaybe'High','Medium'or'Low'whiletheothermayshowas'1','2'or'3'.

同一字段的下拉值也可能不同，如“风险类别”在A系统为“高/中/低”，在B系统却为“1/2/3”。Thismayresultinextradesignelementreconciliationorpossiblesystemdesignchangestoaccommodatethedataexchange.

这可能需要额外进行设计要素对账，甚至调整系统设计以支持数据交换。Thesuggesteddatamodelbelowconstitutesanoverarching,logicallayerofdataelementsthatsponsorsandCMOsmaymaptoandusewithoutdesignchangestofacilitatetheexchange.

下文建议的数据模型提供了一个统一的逻辑数据元素层，申办方与CMO可直接映射使用，无需变更现有系统即可实现交换。ThedataanddescriptionscontainedinTables1and2shouldnotbeconstruedasanexplicitprescription,butratherasaframeworkthatisanticipatedtoevolveovertime.

表1与表2中的数据及描述并非强制性处方，而是一个可随时间演进的框架。

3.4Controlledvocabularies

3.4受控词汇表Itisnotonlythenamesofthefieldsthatshouldbealigned,butalsothevaluesthatcanbecontainedinthosefields.

需要对齐的不仅是字段名称，还包括字段内可填写的取值。Forexample,thestatusdescriptormustbethesameandmeanthesametoensuredataanalyzedfromdifferentsourcesmakessense.

例如，“状态描述符”必须完全一致且含义相同，才能确保来自不同源的数据在分析时具备可比性。Freetextshouldbetheexception.

应尽量避免自由文本，仅将其作为例外。Ofcourse,controllingvocabulariesaccordingtoanexternalstandardmeansthatbothpartiesinapartnershipwillneedtomaptoandfromtheiroperationalsystems(ratherthantheCMOmappingtoeachsponsor'srequirements).

当然，依据外部标准对词汇进行控制，意味着合作双方均需在自己的运营系统与标准词汇之间建立双向映射（而非由CMO单独去适配每一家申办方的要求）。However,oncedone,thatmappingshouldbegoodforfuturepartnershipsandbequickertoimplement,withimprovedaccuracyforeveryone.

然而，一旦完成该映射，未来与其他伙伴合作时即可复用，实施更快、准确性更高。Intime,weexpectthedatamanagedbycompaniesindatalakesanddataproductstoincreasinglyconformtocontrolledvocabulariesand,eventually,forcontrolledvocabulariestobeadoptedintooperationalsystems.

展望未来，企业存放在数据湖和数据产品中的数据将越来越遵循受控词汇表，并最终把受控词汇表直接嵌入运营系统。4.0Casestudy

案例研究ToshowtheoperationalefficiencyoftheproposedstandardsdescribedinChapter4,anautomatedsystembetweenasponsorandCMOwassuccessfullyimplemented.

为验证第4章所述标准的实际运行效率，我们成功落地了一套申办方与CMO间的自动化系统。ThedefinedstandardsstreamlinedthedevelopmentofthepilotbetweentheCMOandsponsor,allowinganexpediteddeploymentwithoutneedingacomprehensiveprojectframework.

既定标准简化了双方试点项目的开发工作，使系统得以快速上线，而无需构建繁复的项目框架。4.1Development

4.1开发阶段Theprojectwasimplementedwiththefollowingprinciplesinmind,highlightingtheneedforuniforminterfaces:

项目遵循以下原则，重点解决接口统一问题：Compliancewithstandards:theimplementationadheredtothefileformat,encodingandfieldstandardsoutlinedinSection3.Byintegratingthesebestpractices,weensuredseamlessinteroperabilitybetweentheCMOandthesponsor.

通过整合这些最佳实践，CMO与申办方实现了无缝互操作。Thisformsthefoundationforacommoninterfacethatisessentialforfurtherprocessing.

该通用接口为后续数据处理奠定了坚实基础。标准合规：实施过程严格采用第3章规定的文件格式、编码及字段标准。Scalability:thesystemwasdesignedwithscalabilityinmind.Althoughinitiallytailoredforonesponsor/CMOrelationship,itcanbeeasilyadaptedtoaccommodateadditionalclientsinthefuture.

尽管当前仅针对单一申办方/CMO关系，未来仍可快速适配更多客户。可扩展性：系统按可扩展思路设计。Terminologyandscopealignment:despitethedefinedstandards,developingacommonglossarywasvitaltoensureauniformunderstandingoftheequivalentofeachdatafield,asdiscrepanciesinterminologybetweentheCMOandsponsorQMSsystemsarose.Itwasestablishedthatadailyexchangefrequencyofdatabesttoensurethetimelytransmissionofdeviationdata.

双方确认以“日”为数据交换频率，保障偏差数据及时传输。术语与范围对齐：即便已有标准，仍需共建统一词汇表，以消除双方QMS系统对同名字段理解的差异。Datasanitization:acrucialaspectoftheimplementationwasthefocusondatasanitization.TheCMOQMSsystememployedastructuredapproachforstoringdeviationdata,enablingtheclearseparationofsponsor-specificinformation,evenwhenmultiplesponsorsareaffectedbyacommondeviation.

CMOQMS采用结构化方式存储偏差数据，即便一起偏差涉及多家申办方，也能清晰区分各自专属信息。Toprotectsensitivecustomerdata,alltransmittedinformationwasverifiedbytheintermediarylayer(SAPBusinessWarehouse)beforebeingsent,therebypreventingpotentialdataleaks.

为保护敏感客户数据，所有外发信息均经中间层（SAPBusinessWarehouse）校验，杜绝潜在泄露。数据脱敏：项目核心环节之一为数据脱敏。4.2Systemoverviewanddataprocessingworkflow

4.2系统概览与数据处理工作流Theautomatedsystemcomprisesthefollowingcomponentsanddataprocessingworkflows:

自动化系统由以下组件与数据处理流程构成：CMO:

CMO侧：QMS:theQMSfunctionsasasourcesystemforallexchangeddata.Inthescopeofthedevelopment,severaldatabaseviewswereestablishedtoprovidetherequiredqualitydataforallpartiesinvolved.

开发阶段已创建若干数据库视图，为各方提供所需质量数据。QMS：作为所有交换数据的源系统。DataWarehousing:thisservesasaverifiedintermediarylayertoguaranteedataqualityandconsistency.Therawqualitydataissanitizedtoonlyincludecustomerdataandismappedtotherequiredfields.

原始质量数据经脱敏后仅保留客户数据，并映射至所需字段。数据仓库：作为经校验的中间层，确保数据质量与一致性。Middleware:thesanitizeddataismappedintothetargetdataformat(e.g.,aCSVfile)andthesecuretransmissionofprocesseddatatoanSFTPserver/RESTAPIisperformed,whichmakesitavailablefordownstreamconsumptionbythesponsor.中间件：脱敏数据被转换为目标格式（如CSV），并通过SFTP/RESTAPI安全传输，供申办方下游系统使用。Sponsor:

申办方侧：Datacloud:thisactsasaningestionlayerforrawdata,enablingsecurestorageandinitialprocessingofdeviationsdatareceivedfromtheCMO.Thiscomponentensuresthatdataisreadilyaccessibleforfurtheranalysisandintegration.

该组件确保数据可被快速访问，用于后续分析与集成。数据云：作为原始数据摄取层，安全存储并初步处理来自CMO的偏差数据。Corporatenetwork:thisfacilitatesdatacleaning,transformationandmapping,ensuringthattheprocesseddatameetstherequiredstandardsforanalysis.Thissecureenvironmentsupportstheoperationaluseofdataacrossvariousapplicationswithinthesponsororganization.

该安全环境支撑申办方内部各应用对数据的运营级使用。企业网：负责数据清洗、转换与映射，确保处理后数据符合分析标准。4.3Impactonthebusinessprocess

4.3对业务流程的影响TheintegrationofdeviationdatafromtheCMOyieldedseveralkeybenefitsfortheoperati