1、Integrated Quality at the Lab 实验室质量整合实验室质量整合 Plant and Enterprise Level 工厂以及企业层 Manufacturing Excellence Days 2012 Quality integrated in Production Operations 生生产过程质量整合产过程质量整合 2 ISA-95四大支柱：工艺以及产品分析四大支柱：工艺以及产品分析 仓库运营仓库运营 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 维维护运营护运营 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 生产运营生产运营 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 质量运营质量运营 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 testtest Response Quality test Request Quality definition management Quality testtest capability Quality analysis Quality definitions Performance Quality test data collection Quality test execution Quality test resource management Quality test dispatching Qual9、ity test tracking Detailed quality test scheduling Quality definition management Quality analysis Performance?SIMATIC IT MES平台覆盖平台覆盖ISA-95所有支柱所有支柱?SIMATIC IT不管功能还是架构，都支持模块化和可扩展，使得能迅速推广不管功能还是架构，都支持模块化和可扩展，使得能迅速推广?开放和多元化的开放和多元化的SIMATIC IT平平台能跨工厂协作并能和台能跨工厂协作并能和ERP，PLM，SCM等进行集成等进行集成 SIMATIC IT Framework10、 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 Intersp11、ec Unilab M Weighing&Dispensing 称重及配送称重及配送 Compliance,Track and Trace,Audit Trail&Genealogy 合合规，追溯及追踪，审计以及族谱规，追溯及追踪，审计以及族谱 第四层 企业级功能 Level 3第三层 工厂MES功能 SIMATIC IT Process Integration流程集成流程集成 1-2层 工厂控制层 SIMATIC IT R&D Suite 研研发套件发套件 SIMATIC IT Enterprise Integration 企业集成企业集成 SIMATIC PCS7 SIPAT PLC&SC12、ADA SIMATIC S7 3rd Party DCC-DCO Alert Management 报报警管理警管理 Batch Review&Approval 批次审批次审阅及放阅及放行行 ERP Ideation 构思构思 Planning 计划计划 Feasibility 可行性可行性 Product Lifecycle Management 产品全生命周期管理产品全生命周期管理(PLM)SIMATIC IT Intelligence Suite SIMATIC WINCC SIMATIC BATCH SIMATIC IT Production Suite Master Recipe M13、anagement生产配方管理生产配方管理 Production Execution&EWI 生产执生产执行及行及 电子工作指导电子工作指导 Quality Control 质量控制质量控制 SIMATIC IT Electronic Batch Record 电子批记录电子批记录 SIMATIC IT Intelligence Suite 智智能套件能套件 Energy能源能源 OEE设备效率设备效率 Maintenance维护维护 SIMATIC IT Asset Management 资产管理资产管理 Simatic IT Historian Integrated Quality wit14、h SIMATIC IT SIMATIC IT质量整合质量整合 Warehouse Management 仓仓库管理库管理 Integrated Quality at Plant and Enterprise Level Workflow for Quality Inspection Process 企业统一的质量审计流程企业统一的质量审计流程 Production Order 生产订单生产订单 MES(SIMATIC IT Production Suite incl Unilab)ERP Production Supervisor 生生产总监产总监 Quality Manager 质质量经理15、量经理 Production Manager 生生产经理产经理 ERP Quality Supervisor 质质量总监量总监 Dispatch Production Order 订单下发订单下发 Activate Quality Workflows 激激活质量流程活质量流程 LIMS 实实验验室管理系统室管理系统 Execution Production Order 执行订单执行订单?The Production order is created and released in ERP生产订单通过ERP下发?Because of Quality Management option Inspe16、ction Lot is created to be later on able to receive appropriate feedback from the plant 根据质量管理要求，一个审计批次在之后会被创建，以准备接收工厂实际数据。Usage Decision 实际运行实际运行 Stock Posting 入库入库 Interoperability Exchanging Transactional Data 数据交互?MES while receiving the production order from ERP,will activate a detailed quality17、 plan(that is coming from the MASTER defined in the ERP plus the EXTENSIONS defined in the MES)接收ERP的生产订单，从而激活一个质量计划（根据ERP的主数据和MES的扩展数据）。?The Quality Workflow will enforce execution of quality actions in the plant such as:质量流程会增强工厂的质量控制:?Create a sample ID to be executed in the Laboratory 在实验室里创建样本?18、Connect to physical devices(such as Scales or other measurement tools)连接物理设备?Activate Corrective Actions 纠偏?Store results to be sent to ERP 存储最终结果到ERP。?The Inspection Lot is updated with just the Corporate significant information被检测的物料只更新企业的重要信息?The usage decision is assigned to ERP使用决策被分配到ERP?Stock19、 with status is updated in the ERP在ERP中更新仓库状态 Interoperability Exchanging Transactional Data 数据交付 SIMATIC IT 研研发发套件套件 核心组件核心组件 实验室信息管理系统实验室信息管理系统/质量管理质量管理 SIMATIC IT Unilab manages the workflow in laboratories,optimizing collection,analysis and reporting of quality data in the lab and on the product20、ion 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管理实验室的工作流，优化实验室和生产线上的质量数据的采集，分析以及报告。管理实验室的工作流，优化实验室和生产线上的质量数据的采集，分析以及报告。ELN的功能是建的功能是建立在立在SIMATIC IT Unilab之21、之上，并充分利用它的核心功能和可配置性为上，并充分利用它的核心功能和可配置性为研发研发部门提供更多的灵活性部门提供更多的灵活性?Streamline and harmonize existing processes when appropriate 在适当的时候简化和协调现有的流程?Make capturing experimental data easy使采集实验数据更容易?Record all useful information and put it in context with experiment,register and document experiments记录一切有用的信息22、并把这些数据用于实验中，注册以及文档实验中?Follow-up and browse through R&D projects and stages跟进并浏览研发项目和阶段?Structure,model,and manage the workflow of R&D projects when necessary研发项目在必要时可以组织，模拟和管理工作流?Make knowledge available within a common repository在通用的库里分享知识 SIMATIC IT Unilab,Option ELN SIMATIC IT Unilab*Laboratory&Q23、uality Information Management System handling all quality data in the lab and production.SIMATIC IT Unilab enables实验室和质量信息管理系统处理实验室里和生产的所有的质量数据:?Equal quality standards across different plants相同的质量标准用于不同的工厂?Seamless integration of QC/QA into all production operations质量控制/质量保证无缝集成到所有的生产过程中?Essential 24、proof of quality for regulatory compliancy质量监管合规性的必要证据?Conformance with all industry and laboratory standards与所有行业以及实验室标准保持一致性(GLP,GAMP,ISO,21CFR11,PAT etc.)Manufacturing Excellence Days 2012 SIMATIC IT Unilab LIMS Core ISA-95 off-line quality component of SIMATIC IT实验室管理系实验室管理系统的核心统的核心ISA-95离线质量组件离25、线质量组件 6 SIMATIC IT Unilab是实验室和生产过程中的断裂带的桥梁，管理实验室工作流，是实验室和生产过程中的断裂带的桥梁，管理实验室工作流，优化实验室和生产线上的质量数据的采集，分析和报告优化实验室和生产线上的质量数据的采集，分析和报告?Management of all quality data(raw materials,intermediate products,finished products,environmental samples,etc.)管理所有的质量数据（原料，半成品，成品，环境样等）?Full support for complex test plan26、s/methods definition and execution in different contexts in a flexible way;用灵活的方法全支持复杂的测试计划/方法定义以及在不同的环境中执行?Instrument connections,equipment&qualification management仪器连接，设备及资质管理?Immediate feedback on quality exceptions对质量异常的即时反馈?Support of quality standards such as GLP,GAMP,ISO,FDA,HACCP 支持如GLP，GAMP27、，ISO，FDA，HACCP等的质量标准?Compliance support to 21 CFR Part 11 21 CFR Part 11的合规支持?Stability Studies Module available提供稳定性研究模块?A unique and unified overview of all quality measures 一个唯一并且统一的整体质量检测标准?Fully integrated in ERP,MES,PLM,lab instrumentation,etc.ERP，MES，PLM，实验室仪器等的全集成 Manufacturing Excellence Da28、ys 2012 Centralized Quality Managament 提供集中的质量管理提供集中的质量管理 7 SIMATIC IT Unilab coordinates Quality Management performed by HQ offices and manufacturing plants plants 可协调可协调/集中总部和各个制造工厂的质量管理集中总部和各个制造工厂的质量管理 集中集中 LIMS/QMS?多地点，多工厂?多语言?多时区?统一的QA/QC规范、方法和过程等.?完整的企业层集成(ERP,MES,测量仪表管理等)?无缝集成企业质量和生产运营 QC实验室实29、验室/生产测试生产测试?Off-line 离线测试?At-line 线边测试?环境测试 制造工厂制造工厂 服服务务/研发实验室研发实验室(总部总部)?复杂测试?研发测试?竞争/复杂分析?循环分析 总部总部 Manufacturing Excellence Days 2012 Flexibility Through Configuration by the Customer 8 SIMATIC IT Unilab 能按照质量流程有效协调并支持每个任务（例如）能按照质量流程有效协调并支持每个任务（例如）SIMATIC IT Unilab RDBMS&Architecture关系型数据库和体系结构 30、报表和图表 确认及验证 分析结果 输入及处理 工作列表 工作清单 方法列表 Sample Login 样本登陆 Log-on 登陆 用户授权 管理 模板样本 计划 工作量管理 报表管理 仪表连接 设备管理 验证管理 异常管理 报警处理 趋势/统计质量控制 报告 归档/备份 Workflow Mgt.and 21CFR11工作流管理和21CFR11 Operational Data Master Data Sample registration 样本登录 Lab Analyst 实验室数据分析 Lab Management 实验室管理 Manufacturing Excellence Days 31、2012 Available on various work stations多样的多样的SIMATCI IT 客户端界面客户端界面 9 Manufacturing Excellence Days 2012 Configurable quality organization 工工厂里的质量相关角色厂里的质量相关角色 SIMATIC IT Unilab facilitates the various roles within the laboratory and production test environment SIMATIC IT Unilab帮助了实验室内和生产测试环境的各种人员帮助了32、实验室内和生产测试环境的各种人员 10 Samples&Instruments Am I prepared for my audit next month?我已经准备好下个月的审核了吗？Have I complied with equipment control procedure?我有没有遵照设备控制流程？Which analyses are delayed?哪些分析被搁置了？What samples are out of spec?哪些样本不符合特征？实验室经理实验室经理 Why does the“Brussels”site analyse 50%more micro-biology th33、an the“Stuttgart”site?为什么“布鲁塞尔”现场分析出比“斯图加特”多50%的微生物？New product specifications to be sent to labs Rome and Chicago?新产品特征被送到”罗马”和”芝加哥”实验室 质监经理质监经理(公司公司)Will the lab be able to process all entered raw material samples today?实验室今天能够处理所有输入的原材料样本吗？How long do I have to wait for the results of my samples 34、after fermentation?在发酵后我要等多久才能知道我的样本结果？产品经理产品经理 How do I perform this analysis?我如何操作这个分析？What are my priorities for today?我今天的首要任务是什么？Can I use this HPLC or not?我可以使用这个GC吗？微生物微生物/化学分析员化学分析员 Did we find product contaminations?哪些产品已经到了保质期？Is environmental monitoring OK?这个颜色是玫瑰红还是洋红？传感分析员传感分析员 Manufact35、uring Excellence Days 2012 Uniconnect integrates laboratory equipment(1/2)仪表连接仪表连接-Uniconnect(1/2)Instrument connections via serial interface仪表通过串口发送结果仪表通过串口发送结果 11 RS-232 Manufacturing Excellence Days 2012 Uniconnect integrates laboratory equipment(2/2)仪表连接仪表连接-Uniconnect(2/2)12 Uniconnect GC GC in36、put file SIMATIC IT Unilab Uniconnect template for GC Exception Handling through Workflow Management Example for regulated production lab异常处理流程异常处理流程 C:at least one parameter started至少有一个参数开始分析 SIMATIC IT Unilab manages 95%of samples(bulk of work)Unilab管理 95%的样品 Manage manually 5%of samples(exceptio37、ns)手动管理5%的样品 Confirm On Hold确认暂停确认暂停 Rejected拒绝拒绝 S开始开始 Available可用可用 A:Print label打印标签 In Execution执行中执行中 C:all parameters completed所有参数完成 Wait for Release等待放行等待放行 C:all parameters within specs所有参数在规格内 C:at least one parameter out of specs至少一个参数在规格外 C:at least one parameter added至少增加一个参数 C:manually38、 by lab mgr实验室经理手动输入 C:manually by prod mgr生产经理手动输入 C:manually by lab mgr实验室经理手动输入 C:manually by prod mgr生产经理手动输入 A:Print exception report打印异常报告 Completed完成完成 On Hold暂停暂停 Released放行放行 C:manually by QA质保人员手动输入 Exception handling and SQC异常处理及异常处理及SQC Reporting embedded in SIMATIC IT Unilab SIMATIC IT 39、Unilab内置报表内置报表 Full reporting capabilities of SIMATIC IT Report Manager integrated in SIMATIC IT Unilab报表管理器的全部报表制作能力集成入报表管理器的全部报表制作能力集成入SIMATIC IT Unilab?Pre-defined reports 预定义报表预定义报表?Automatic reporting自动报表自动报表?Time based(e.g.daily non-conformance report)基于时间（如日常的无一致性报表）?Event based(e.g.COA upon 40、validation work)基于事件（如认证工作中的COA）?Via fax/e-mail/internet/通过传真/电子邮件/互联网 Time for demo案例呈现案例呈现 References in chemical and pharmaceuticals Installed base in pharmaceuticals SIMATIC IT Unilab?Enterprise wide quality management企业范围内的质量管理企业范围内的质量管理?Integration with ERP集成集成ERP?Reporting,Electronic Signatur41、es&21CFR11 Compliance报告，报告，电子签名和电子签名和21CFR11合规合规 SIMATIC IT Unilab?Lab efficiency实验室效率实验室效率?Reliable quality control processes可靠的质量控制流程可靠的质量控制流程?GLP/Validation/Environmental Monitoring/Stability GLP/验证验证/环境监测环境监测/稳定稳定 Part of Boehringer Ingelheim Part of Merck Installed base in pharmaceuticals SIMAT42、IC IT Unilab?Standardization of quality management systems标准化的质量管标准化的质量管理体系理体系?Automation of labs in R&D 研发实验室自动化研发实验室自动化?Compliance with 21CFR11 and own standards遵守遵守21CFR11和自和自己的标准己的标准 SIMATIC IT Unilab&SIMATIC IT Interspec?Integration QC specification management ERP production一体化的一体化的QC-规范管理规范管理-43、ERP系统系统-生产生产?Electronic and automated quality workflows电子和自动化质量工电子和自动化质量工作流程作流程?Higher productivity and flexibility of the manufacturing facilities更高的生产率和灵活性的生产设施更高的生产率和灵活性的生产设施 Installed base in pharmaceuticals Roche MAB Basel Switzerland?SIMATIC IT Production Suite+SIMATIC IT Unilab(at line testin44、g)?TCO advantage Roll-out capabilities of Roche BioMES standard TCO优势 Roche BioMES标准的推广能力?Integrated Quality质量整合 Roche NPK Kaiseraugst Switzerland?SIMATIC IT Unilab?Environmental Monitoring(EM)in sterile drug manufacturing无菌药品生产中的环境监测（EM）?Proven LIMS in validated environment验证环境中成熟的实验室管理系统 Installed45、 base in pharmaceuticals Roche Mannheim Germany?SIMATIC IT Unilab?Roll out of Kaiseraugst Kaiseraugst推广?Environmental Monitoring and Water Sampling in sterile drug manufacturing在无菌药品生产环境监测和水质采样 Roche Basel and Kaiseraugst Switzerland?Ongoing Roll-outs to other divisions Ongoing推广到其他部门推广到其他部门?SIMATIC IT Unilab is the standard for EM in Roche division sterile drug manufacturing SIMATIC IT Unilab是是Roche无无菌药品生产部门标准的环境监测系统菌药品生产部门标准的环境监测系统