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1、Integrated Quality at the Lab 實驗室質量整合實驗室質量整合 Plant and Enterprise Level 工廠以及企業層 Manufacturing Excellence Days 2012 Quality integrated in Production Operations 生產過程質量整合生產過程質量整合 2 ISA-95四大支柱：工藝以及產品分析四大支柱：工藝以及產品分析 倉庫運營倉庫運營 Inventory data collection Inventory execution Inventory resource management Inve2、ntory dispatching Inventory tracking Inventory response Detailed Inventory scheduling Inventory request Inventory definition management Inventory capability Inventory analysis Inventory definitions Inventory data collection Inventory execution Inventory resource management Inventory dispatching Inve3、ntory tracking Detailed Inventory scheduling Inventory definition management Functions defined in ISA-95 part 3 Quality OperationQuality Operation P P S P I C Q A O P P C M M Functions defined in ISA-95 part 3 P P S M&E C P I C P C A Q A R&D&E P S A O P M&S P C M M Quality test data collection Quali4、ty test execution Quality test dispatching Quality test tracking Quality definition management Source:Team MES/CMMS 維護運營維護運營 DataData Maintenance Response Maintenance Request Maintenance Capability Maintenance Definitions Maintenance Data Collection Maintenance Execution Maintenance Resource Managem5、ent Maintenance Dispatching Maintenance Tracking Detailed Maintenance Scheduling Maintenance Definition Management Maintenance Analysis Functions defined in ISA-95 part 3 P P S M&E C P I C P C A Q A R&D&E P S A O P M&S P C M M datadata resourceresource Production data collection Production execution6、 Production resource management Production dispatching Production tracking Production performance Detailed production scheduling Production schedule Product definition management Production Performance analysis Production capability Product definition Functions defined in ISA-95 part 3 生產運營生產運營 P P 7、S M&E C P I C P C A Q A R&D&E P S A O P M&S P C M M Functions defined in ISA-95 part 3 質量運營質量運營 P P S M&E C P I C P C A Q A R&D&E P S A O P M&S P C M M Functions defined in ISA-95 part 3 P P S M&E C P I C A Q A R&D&E O P M&S P C M M Quality test data collection Quality test execution Quality test di8、spatching Quality test tracking Quality test test Response Quality test Request Quality definition management Quality test test capability Quality analysis Quality definitions Performance Quality test data collection Quality test execution Quality test resource management Quality test dispatching Qu9、ality test tracking Detailed quality test scheduling Quality definition management Quality analysis Performance SIMATIC IT MES平臺覆蓋平臺覆蓋ISA-95所有支柱所有支柱 SIMATIC IT不管功能還是架構，都支持模塊化和可擴展，使得能迅速推廣不管功能還是架構，都支持模塊化和可擴展，使得能迅速推廣 開放和多元化的開放和多元化的SIMATIC IT平臺能跨工廠協作并能和平臺能跨工廠協作并能和ERP，PLM，SCM等進行集成等進行集成 SIMATIC IT Framewo10、rk Level 4 Business Planning&Logistics Level 3 MES Level 0,1,2 Control Third party DB ERP System Business Data Integration B2MML PLM System SCM Process Data Integration OPC RFID BATCH CONTROL CONTINUOUS CONTROL DISCRETE CONTROL SIMATIC IT Components SIMATIC IT Industry Libraries Report Manager Inter11、spec Unilab M Weighing&Dispensing 稱重及配送稱重及配送 Compliance,Track and Trace,Audit Trail&Genealogy 合規，追溯及追蹤，審計以及族譜合規，追溯及追蹤，審計以及族譜 第四層 企業級功能 Level 3第三層 工廠MES功能 SIMATIC IT Process Integration流程集成流程集成 1-2層 工廠控制層 SIMATIC IT R&D Suite 研發套件研發套件 SIMATIC IT Enterprise Integration 企業集成企業集成 SIMATIC PCS7 SIPAT PLC&12、SCADA SIMATIC S7 3rd Party DCC-DCO Alert Management 報警管理報警管理 Batch Review&Approval 批次審閱及放行批次審閱及放行 ERP Ideation 構思構思 Planning 計劃計劃 Feasibility 可行性可行性 Product Lifecycle Management 產品全生命周期管理產品全生命周期管理(PLM)SIMATIC IT Intelligence Suite SIMATIC WINCC SIMATIC BATCH SIMATIC IT Production Suite Master Recipe13、 Management生產配方管理生產配方管理 Production Execution&EWI 生產執行及生產執行及 電子工作指導電子工作指導 Quality Control 質量控制質量控制 SIMATIC IT Electronic Batch Record 電子批記錄電子批記錄 SIMATIC IT Intelligence Suite 智能套件智能套件 Energy能源能源 OEE設備效率設備效率 Maintenance維護維護 SIMATIC IT Asset Management 資產管理資產管理 Simatic IT Historian Integrated Quality w14、ith SIMATIC IT SIMATIC IT質量整合質量整合 Warehouse Management 倉庫管理倉庫管理 Integrated Quality at Plant and Enterprise Level Workflow for Quality Inspection Process 企業統一的質量審計流程企業統一的質量審計流程 Production Order 生產訂單生產訂單 MES(SIMATIC IT Production Suite incl Unilab)ERP Production Supervisor 生產總監生產總監 Quality Manager 質量經15、理質量經理 Production Manager 生產經理生產經理 ERP Quality Supervisor 質量總監質量總監 Dispatch Production Order 訂單下發訂單下發 Activate Quality Workflows 激活質量流程激活質量流程 LIMS 實驗室管理系統實驗室管理系統 Execution Production Order 執行訂單執行訂單 The Production order is created and released in ERP生產訂單通過ERP下發 Because of Quality Management option Ins16、pection Lot is created to be later on able to receive appropriate feedback from the plant 根據質量管理要求，一個審計批次在之后會被創建，以準備接收工廠實際數據。Usage Decision 實際運行實際運行 Stock Posting 入庫入庫 Interoperability Exchanging Transactional Data 數據交互 MES while receiving the production order from ERP,will activate a detailed quali17、ty plan(that is coming from the MASTER defined in the ERP plus the EXTENSIONS defined in the MES)接收ERP的生產訂單，從而激活一個質量計劃（根據ERP的主數據和MES的擴展數據）。The Quality Workflow will enforce execution of quality actions in the plant such as:質量流程會增強工廠的質量控制:Create a sample ID to be executed in the Laboratory 在實驗室里創建樣本 18、Connect to physical devices(such as Scales or other measurement tools)連接物理設備 Activate Corrective Actions 糾偏 Store results to be sent to ERP 存儲最終結果到ERP。The Inspection Lot is updated with just the Corporate significant information被檢測的物料只更新企業的重要信息 The usage decision is assigned to ERP使用決策被分配到ERP Stock 19、with status is updated in the ERP在ERP中更新倉庫狀態 Interoperability Exchanging Transactional Data 數據交付 SIMATIC IT 研發套件研發套件 核心組件核心組件 實驗室信息管理系統實驗室信息管理系統/質量管理質量管理 SIMATIC IT Unilab manages the workflow in laboratories,optimizing collection,analysis and reporting of quality data in the lab and on the producti20、on line.The ELN function is built on top of SIMATIC IT Unilab,and leverages its core functions and configuration possibilities to offer more flexibility for the R&D community SIMATIC IT Unilab管理實驗室的工作流，優化實驗室和生產線上的質量數據的采集，分析以及報告。管理實驗室的工作流，優化實驗室和生產線上的質量數據的采集，分析以及報告。ELN的功能是建的功能是建立在立在SIMATIC IT Unilab之上21、，并充分利用它的核心功能和可配置性為研發部門提供更多的靈活性之上，并充分利用它的核心功能和可配置性為研發部門提供更多的靈活性 Streamline and harmonize existing processes when appropriate 在適當的時候簡化和協調現有的流程 Make capturing experimental data easy使采集實驗數據更容易 Record all useful information and put it in context with experiment,register and document experiments記錄一切有用的信息并22、把這些數據用于實驗中，注冊以及文檔實驗中 Follow-up and browse through R&D projects and stages跟進并瀏覽研發項目和階段 Structure,model,and manage the workflow of R&D projects when necessary研發項目在必要時可以組織，模擬和管理工作流 Make knowledge available within a common repository在通用的庫里分享知識 SIMATIC IT Unilab,Option ELN SIMATIC IT Unilab*Laboratory&Qu23、ality Information Management System handling all quality data in the lab and production.SIMATIC IT Unilab enables實驗室和質量信息管理系統處理實驗室里和生產的所有的質量數據:Equal quality standards across different plants相同的質量標準用于不同的工廠 Seamless integration of QC/QA into all production operations質量控制/質量保證無縫集成到所有的生產過程中 Essential pr24、oof of quality for regulatory compliancy質量監管合規性的必要證據 Conformance with all industry and laboratory standards與所有行業以及實驗室標準保持一致性(GLP,GAMP,ISO,21CFR11,PAT etc.)Manufacturing Excellence Days 2012 SIMATIC IT Unilab LIMS Core ISA-95 off-line quality component of SIMATIC IT實驗室管理系統的核心實驗室管理系統的核心ISA-95離線質量組件離線質25、量組件 6 SIMATIC IT Unilab是實驗室和生產過程中的斷裂帶的橋梁，管理實驗室工作流，優化實驗室和生產線上的質量數據的采集，分析和報告是實驗室和生產過程中的斷裂帶的橋梁，管理實驗室工作流，優化實驗室和生產線上的質量數據的采集，分析和報告 Management of all quality data(raw materials,intermediate products,finished products,environmental samples,etc.)管理所有的質量數據（原料，半成品，成品，環境樣等）Full support for complex test plans/m26、ethods definition and execution in different contexts in a flexible way;用靈活的方法全支持復雜的測試計劃/方法定義以及在不同的環境中執行 Instrument connections,equipment&qualification management儀器連接，設備及資質管理 Immediate feedback on quality exceptions對質量異常的即時反饋 Support of quality standards such as GLP,GAMP,ISO,FDA,HACCP 支持如GLP，GAMP，IS27、O，FDA，HACCP等的質量標準 Compliance support to 21 CFR Part 11 21 CFR Part 11的合規支持 Stability Studies Module available提供穩定性研究模塊 A unique and unified overview of all quality measures 一個唯一并且統一的整體質量檢測標準 Fully integrated in ERP,MES,PLM,lab instrumentation,etc.ERP，MES，PLM，實驗室儀器等的全集成 Manufacturing Excellence Days 28、2012 Centralized Quality Managament 提供集中的質量管理提供集中的質量管理 7 SIMATIC IT Unilab coordinates Quality Management performed by HQ offices and manufacturing plants plants 可協調可協調/集中總部和各個制造工廠的質量管理集中總部和各個制造工廠的質量管理 集中集中 LIMS/QMS 多地點，多工廠 多語言 多時區 統一的QA/QC規范、方法和過程等.完整的企業層集成(ERP,MES,測量儀表管理等)無縫集成企業質量和生產運營 QC實驗室實驗室/生產29、測試生產測試 Off-line 離線測試 At-line 線邊測試 環境測試 制造工廠制造工廠 服務服務/研發實驗室研發實驗室(總部總部)復雜測試 研發測試 競爭/復雜分析 循環分析 總部總部 Manufacturing Excellence Days 2012 Flexibility Through Configuration by the Customer 8 SIMATIC IT Unilab 能按照質量流程有效協調并支持每個任務（例如）能按照質量流程有效協調并支持每個任務（例如）SIMATIC IT Unilab RDBMS&Architecture關系型數據庫和體系結構 報表和圖表 30、確認及驗證 分析結果 輸入及處理 工作列表 工作清單 方法列表 Sample Login 樣本登陸 Log-on 登陸 用戶授權 管理 模板樣本 計劃 工作量管理 報表管理 儀表連接 設備管理 驗證管理 異常管理 報警處理 趨勢/統計質量控制 報告 歸檔/備份 Workflow Mgt.and 21CFR11工作流管理和21CFR11 Operational Data Master Data Sample registration 樣本登錄 Lab Analyst 實驗室數據分析 Lab Management 實驗室管理 Manufacturing Excellence Days 2012 A31、vailable on various work stations多樣的多樣的SIMATCI IT 客戶端界面客戶端界面 9 Manufacturing Excellence Days 2012 Configurable quality organization 工廠里的質量相關角色工廠里的質量相關角色 SIMATIC IT Unilab facilitates the various roles within the laboratory and production test environment SIMATIC IT Unilab幫助了實驗室內和生產測試環境的各種人員幫助了實驗室內和生32、產測試環境的各種人員 10 Samples&Instruments Am I prepared for my audit next month?我已經準備好下個月的審核了嗎？Have I complied with equipment control procedure?我有沒有遵照設備控制流程？Which analyses are delayed?哪些分析被擱置了？What samples are out of spec?哪些樣本不符合特征？實驗室經理實驗室經理 Why does the“Brussels”site analyse 50%more micro-biology than the33、“Stuttgart”site?為什么“布魯塞爾”現場分析出比“斯圖加特”多50%的微生物？New product specifications to be sent to labs Rome and Chicago?新產品特征被送到”羅馬”和”芝加哥”實驗室 質監經理質監經理(公司公司)Will the lab be able to process all entered raw material samples today?實驗室今天能夠處理所有輸入的原材料樣本嗎？How long do I have to wait for the results of my samples after 34、fermentation?在發酵后我要等多久才能知道我的樣本結果？產品經理產品經理 How do I perform this analysis?我如何操作這個分析？What are my priorities for today?我今天的首要任務是什么？Can I use this HPLC or not?我可以使用這個GC嗎？微生物微生物/化學分析員化學分析員 Did we find product contaminations?哪些產品已經到了保質期？Is environmental monitoring OK?這個顏色是玫瑰紅還是洋紅？傳感分析員傳感分析員 Manufacturing 35、Excellence Days 2012 Uniconnect integrates laboratory equipment(1/2)儀表連接儀表連接-Uniconnect(1/2)Instrument connections via serial interface儀表通過串口發送結果儀表通過串口發送結果 11 RS-232 Manufacturing Excellence Days 2012 Uniconnect integrates laboratory equipment(2/2)儀表連接儀表連接-Uniconnect(2/2)12 Uniconnect GC GC input fi36、le SIMATIC IT Unilab Uniconnect template for GC Exception Handling through Workflow Management Example for regulated production lab異常處理流程異常處理流程 C:at least one parameter started至少有一個參數開始分析 SIMATIC IT Unilab manages 95%of samples(bulk of work)Unilab管理 95%的樣品 Manage manually 5%of samples(exceptions)手動管37、理5%的樣品 Confirm On Hold確認暫停確認暫停 Rejected拒絕拒絕 S開始開始 Available可用可用 A:Print label打印標簽 In Execution執行中執行中 C:all parameters completed所有參數完成 Wait for Release等待放行等待放行 C:all parameters within specs所有參數在規格內 C:at least one parameter out of specs至少一個參數在規格外 C:at least one parameter added至少增加一個參數 C:manually by la38、b mgr實驗室經理手動輸入 C:manually by prod mgr生產經理手動輸入 C:manually by lab mgr實驗室經理手動輸入 C:manually by prod mgr生產經理手動輸入 A:Print exception report打印異常報告 Completed完成完成 On Hold暫停暫停 Released放行放行 C:manually by QA質保人員手動輸入 Exception handling and SQC異常處理及異常處理及SQC Reporting embedded in SIMATIC IT Unilab SIMATIC IT Unilab39、內置報表內置報表 Full reporting capabilities of SIMATIC IT Report Manager integrated in SIMATIC IT Unilab報表管理器的全部報表制作能力集成入報表管理器的全部報表制作能力集成入SIMATIC IT Unilab Pre-defined reports 預定義報表預定義報表 Automatic reporting自動報表自動報表 Time based(e.g.daily non-conformance report)基于時間（如日常的無一致性報表）Event based(e.g.COA upon validat40、ion work)基于事件（如認證工作中的COA）Via fax/e-mail/internet/通過傳真/電子郵件/互聯網 Time for demo案例呈現案例呈現 References in chemical and pharmaceuticals Installed base in pharmaceuticals SIMATIC IT Unilab Enterprise wide quality management企業范圍內的質量管理企業范圍內的質量管理 Integration with ERP集成集成ERP Reporting,Electronic Signatures&21CFR41、11 Compliance報告，報告，電子簽名和電子簽名和21CFR11合規合規 SIMATIC IT Unilab Lab efficiency實驗室效率實驗室效率 Reliable quality control processes可靠的質量控制流程可靠的質量控制流程 GLP/Validation/Environmental Monitoring/Stability GLP/驗證驗證/環境監測環境監測/穩定穩定 Part of Boehringer Ingelheim Part of Merck Installed base in pharmaceuticals SIMATIC IT Un42、ilab Standardization of quality management systems標準化的質量管標準化的質量管理體系理體系 Automation of labs in R&D 研發實驗室自動化研發實驗室自動化 Compliance with 21CFR11 and own standards遵守遵守21CFR11和自和自己的標準己的標準 SIMATIC IT Unilab&SIMATIC IT Interspec Integration QC specification management ERP production一體化的一體化的QC-規范管理規范管理-ERP系統系統-43、生產生產 Electronic and automated quality workflows電子和自動化質量工電子和自動化質量工作流程作流程 Higher productivity and flexibility of the manufacturing facilities更高的生產率和靈活性的生產設施更高的生產率和靈活性的生產設施 Installed base in pharmaceuticals Roche MAB Basel Switzerland SIMATIC IT Production Suite+SIMATIC IT Unilab(at line testing)TCO ad44、vantage Roll-out capabilities of Roche BioMES standard TCO優勢 Roche BioMES標準的推廣能力 Integrated Quality質量整合 Roche NPK Kaiseraugst Switzerland SIMATIC IT Unilab Environmental Monitoring(EM)in sterile drug manufacturing無菌藥品生產中的環境監測（EM）Proven LIMS in validated environment驗證環境中成熟的實驗室管理系統 Installed base in p45、harmaceuticals Roche Mannheim Germany SIMATIC IT Unilab Roll out of Kaiseraugst Kaiseraugst推廣 Environmental Monitoring and Water Sampling in sterile drug manufacturing在無菌藥品生產環境監測和水質采樣 Roche Basel and Kaiseraugst Switzerland Ongoing Roll-outs to other divisions Ongoing推廣到其他部門推廣到其他部門 SIMATIC IT Unilab46、 is the standard for EM in Roche division sterile drug manufacturing SIMATIC IT Unilab是是Roche無無菌藥品生產部門標準的環境監測系統菌藥品生產部門標準的環境監測系統 Thank You!微信掃描左邊二維碼 關注公眾號 即可免費下載：HR精品資料行政管理實操大全-500份管理培訓視頻1000本管理電子書 5000套PPT模板財務/銷售/生產/等管理資料（無任何附加條件 純分享）微信掃描左邊二維碼 關注公眾號 即可免費下載：HR精品資料行政管理實操大全-500份管理培訓視頻1000本管理電子書 5000套PPT模板財務/銷售/生產/等管理資料（無任何附加條件 純分享）微信掃描左邊二維碼 關注公眾號 即可免費下載：HR精品資料行政管理實操大全-500份管理培訓視頻1000本管理電子書 5000套PPT模板財務/銷售/生產/等管理資料（無任何附加條件 純分享）微信掃描左邊二維碼 關注公眾號 即可免費下載：HR精品資料行政管理實操大全-500份管理培訓視頻1000本管理電子書 5000套PPT模板財務/銷售/生產/等管理資料（無任何附加條件 純分享）