电子批记录（EBR）简介
With the national promotion to the pharmaceutical automation process, theelectronic batch record system enter the manufacturing is imminent. Thefollowing introduces the advantages and general functions of the electronicbatch record system (EBR) software.
随着国家对制药自动化进程的推动，电子批记录系统（EBR）进入制造阶段已经迫在眉睫，以下介绍一下电子批记录系统（EBR）软件一般具有的优势和功能。
Making sure eachmanufacturing batch record meets regulatory requirements is a challenging task.This is because in today’s pharmaceutical manufacturing environment, productionruns are shorter, product complexity is increasing and quality expectations aregreater.
确保每批次生产批记录具备合规性要求是一个非常有挑战的任务。如今的制药生产环境，生产周期缩短、生产复杂性增加、质量期望更高。
Manufacturing teams are under significantpressure to keep track of manufacturing batch record generation and much more.Relying on manual or hybrid systems can be time consuming when there are:
这些都给我们的生产制造团队带了巨大的压力，需要跟踪更多生产批记录生成，依靠手动或者混合系统可能会更费时：
· Frequent product changeovers
· 频繁更换产品
· An increasing number of batches
· 批次数量不断增加
· A changing number of employees
· 员工数量的变化（离职、新入职、转岗等）
· Industry estimates state that 5-15%of data entries include errors
行业约有5-15%数据输入错误
· Batch release reviews can occur daysor even weeks after the data was inputted
批放行审核需要在数据输入后数天甚至数周后才进行
· Teams are under significant pressureto find all data and explain what occurred across different shifts
制造人员面临巨大压力，需要找到所有数据，并解释在不同的转变过程中发生了什么
EBR software hastransformed life science manufacturing. Our clients have seen:
EBR软件已经改变了生命科学制造的方式。从我们客户可以观察到：
· Data entry times reduced by 40-80%
数据输入次数减少了40%-80%
· Release times accelerated by 50-80%
放行时间加速了50%-80%
· Improved ability to keep track ofmanufacturing
提高了生产持续追踪能力
At every stage ofthe manufacturing process, EBR software can make to keeping track of andaccelerating manufacturing operations.
在生产制造过程的每一个阶段，其在EBR软件中加速生产操作和持续追踪方面的不同之处。
Cost savings
成本节约
Some EBR softwarehas created a 12 hour saving on batch review and approval. This meant ourclient saved 1,200 hours or 150 days for every 100 batches.
某些EBR（电子批记录）软件每批次可以节约大概12小时审核和批准时间。每100个批次为我们客户100批次节约了1,200小时或者150天时间。
Automatic alerts forexceptions
异常自动报警
EBR pharma systems efficiently identifyissues. EBR will automatically alert the operator to an exception, using aclear visual popup signal.
It can alsoautomatically alert key staff by email, with details of:
EBR系统可以有效识别问题。EBR将自动向操作员发出异常报警。
还可以自动通过电子邮件或者其他方式提醒关键员工，具体如下：
· The batch exception 批次异常
· Time detected 时间检测
· Cause indicator 成本指标
technology willautomatically capture values directly from the PLC/ SCADA system. The softwarewill also enter them in the batch record, saving valuable time. It willinstantly perform any calculations required and enter them, ensuring 100%accuracy. It can also integrate to existing PLC/ SCADA, OPC Server and a widerange of other control systems.
EBR将自动捕获PLC/SCADA系统，软件还会将它们录入批记录，节省宝贵时间。它将立即执行所需的任何计算并输入它们。确保100%的准确性。它还可以集成到现在PLC/ SCADA, OPC服务器和广泛的其他控制系统。
Keep track in real time
实时跟踪
EBR software givesusers real time access to manufacturing. Production and quality can receiveinstant automatic notifications when an exception has been generated.
It provides dashboards for KPIs so you can instantly report with the latestdata for all batches. This also means that the daily production meeting statusand metrics are already there.
EBR软件使用户实时访问生产系统。当生成异常时，生产和质量可以立即收到自动通知。
他为KPI提供了指示板，所以你能立即报告所有批次的最新数据。这也意味着每天的生产会议状态和度量已经在这里了。
Efficient operationalprocess 高效的操作流程
EBR automaticallydisplays the approved versions of all documents and drawings needed for eachpiece of equipment. They can be displayed on a web page or as a hyperlink forusers. It automatically logs which user has completed the setup and provideselectronic signatures to speed up sign-off.
EBR自动显示每台设备所需的所有文件和图纸的批准版本，他们可以显示在网页上或作为用户的超链接。它自动记录已经完成操作的用户，并提供电子签名，以加速签名流程。
Faster calibrationchecks
更快的校准检查
EBR software iseasily interfaced to the maintenance management system and the calibrationstatus can be checked automatically in seconds. It can also be checked earlierin the process to avoid further delays. What’s more, notifications can beissued to a maintenance group as a call to action.
EBR软件更容易和维护管理系统互通，可以在几秒钟内自动检查校准状态。还可以在过程的早期进行复核，以避免进一步的延迟。更重要的是，可以向维护岗位发出通知作为其工作提醒。
Accelerate inputswith electronic batch recording systems for pharma
电子批记录系统自动获取
Software fullyintegrates to LIMS and similar systems. It will automatically capture LIMSresults for batch sample points as soon as they are available. Our softwarewill also enter them into the batch record, saving time and ensuring accuracy.Quality reviews are also accelerated.
软件完全可以集成至LIMS和类似系统，它可以自动捕获批量采样点LIMS结果，一旦检测数据时可用的，我们的软件会将它们直接输入到批记录中，节省时间，确保准确性。将加快质量审核。
Ensuring operatorsare working where needed
确保操作人员具备相关工作的能力
cutting-edgesoftware can automatically verify the training status of operators byinterfacing with the training record management system. It can alert users toexceptions and if required, request them to do a read and understand real-time.It can be configured to stop users proceeding if they are not trained.
EBR软件可以通过培训记录管理系统接口，自动验证操作员的培训状态。他可以向用户发出异常警报，如果需要，请求他们实时进行读取和理解。如果用户没有经过培训，可以将其配置为停止用户的程序中。
EBR software: thekey functions of Shopfloor-Online
Ultimately, EBR providesall of these capabilities and more to drive productivity and make largeefficiency savings during life Pharmaceutical manufacturing. It provides:
总结起来，EBR提供了所有这些能力，并在制药制造过程中提高生产力，节省大量效率。一套完整的制药智能化系统一般包括以下方面：
· Electronic batch records (EBR)
· 电子批记录(EBR)
· Electronic device history records(eDHR)
电子备份历史记录(eDHR)
· Weigh and dispense
称配
· Equipment management
设备管理
· Electronic work instructions (eWI)for setup or cleaning
创建电子说明书
· Electronically generated forms forvariety of applications like APRs, Tech
电子生成的形式包括各种应用，如APRs，tech等
· Transfers, Metrology, ValidationDocumentation.
交接、计量、验证文件
· Pre-defined workflow templates and alibrary structure for building master batch or device records
预先定义的工作流模板和用于构建主批记录或设备记录的库结构
· Full integration with existing systems
与已有系统的全面互通
· A web-based system to avoid a heavyIT footprint
一个基于web系统，以避免沉重的IT足迹
· Simple screens allowing users to dragand drop master batch record configuration
人性化界面设计，允许用户进行主批记录的配置
· Modular licenses, only pay for whatyou use
模块化许可，只支付您所使用的内容
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