LIMS的历史、发展和实施应用(英文+中文)[个人整理]

1. history
Prior to the 1980’s laboratories controlled their workflow manually using paperwork systems. They basically used these to control samples, testing and collate results. As the number of samples requiring test and demands for quicker results increased, so the systems bagan to fail. Initially, individual and regulatory demands increased so more and more laboratories bagan to use bigger and bigger programs to control administration. Automation of some lab testing began to appear but software lagged behind.
   Commercial versions of some lab systems began to appear in the market. Although it was basic to compare to those today, they became popular with lab staff because the removed much of tedium of the work.. Over the years the software improved and with the introduction of the Windows operating system the applications became more sophisticated. LIMS systems appeared in the 1980’s. Most of the early systems used mini-computers and a hierarchical database structure and a proprietary database configuration. They had big disadvantages:
Costly, user unfriendliness, inability to move data out of LIMS. Next came PC’s with the same database structure and proprietary database configurations.
By the early nineties Windows was becoming more and more popular. However, few LIMS vendors could convert their complicated applications form DOS or UNIX over to Microsoft Windows environment. The majority of today’s LIMS systems use (ISAM) databases such as Microsoft Access for smaller labs whilst larger systems are typically based UNIX on and use (SQL) such as Oracle and Microsoft SQL server.
2 LIMS Development
Firstly, what is a LIMS ?
Laboratory Information Management Systems (LIMS) are information management systems designed specifically for the analytical laboratory. This includes research and development(R&D) labs, in-process testing labs, quality assurance (QA) labs, and more. Typically, LIMS connect the analytical instruments in the lab to one or more workstations or personal computers (PC). These instruments such as chromatographs are used to collect data. An instrument interface such as an integrator is used to forward the data from the chromatograph to the PC, where the data is organized into meaningful information. This information is further sorted and organized into various report formats based upon the type of report required.

Most LIMS products allow the laboratory to ; register work requests; print analytical worksheets; monitor and communicate sample/technique backlogs; schedule work; acquire and store analytical data; monitor the quality of all analytical work; approve analytical data to client release; print and store analytical reports and invoices; protect the security of all data; track and locate samples in storage; track and communicate all quality control in the laboratory; provide laboratory management with production and financial statistics and with client information, e.g., names , address, sales figures, etc. An appropriately designed and installed LIMS can quickly bring accuracy and accessibility to the flow of samples and data in any laboratory. The real value of a LIMS is the ability to maximize sample throughput and minimize labor costs.

Laboratory throughput is improved in a number of different ways. The most obvious gain in productivity occurs through the ability for data entry via on-line instruments. Also, there will be a significant decrease in data entry errors. Finally, the up-to-date sample in-flow data available from a typical LIMS allows laboratory supervisors and bench personnel to better schedule analytical work, minimize “downtime” and maximize batch size. Some other effects are that there are better visible quality control checks and centralized data. The ability to monitor, track and communicate data and quality control information gives the laboratory the tools to improve methods and work practices. The end result is that people in the laboratory are able to process more samples per hour worked.

LIMS development is continuing unabated. Demands for more specialized functions have driven LIMS into areas of genetic research, bioinformatics and MES integration. LIMS vendors are developing customized modules for large corporate customers. Modules such as Customer Relationship Manager, HPLC Data Management, Chemical Inventory and Equipment Calibration Management are all readily available.
The integration into large applications such as E.R.P. and M.E.S. is now commonplace. Other LIMS applications allow external laboratory customers to access the system via the internet to view results in real-time, thereby effectively contracting out the need for their own laboratory.

3 Design and Implementation
The design stage prior to acquiring a LIMS involves the review and analysis of available software/hardware packages as well as the definition and documentation of your own laboratory’s requirements. The possible error here could be that bench personnel are excludes form the process. To resolve this problem it is recommended that you have frequent meetings with the personnel in your lab that will use the system.

Some laboratories might go into a LIMS program believing that future requirements for bench level supervision will be reduced or eliminated. It has been recognized by many that LIMS is simply a tool and as such cannot manage the laboratory or take the place of personnel supervision. A LIMS will effectively provide current, reliable and complete operational data. The easy access to accurate data allow management to significantly enhance the quality and speed of decision-making. Decision-making becomes based more on fact rather than instincts.

The average software professional does not usually have the background to effectively interpret a laboratory’s requirements. This communication problem can manifest itself in LIMS systems that do not easily fit into laboratory operations. Often the laboratory must significantly alter procedures and work flow in order to conform to the LIMS. This requirement for wholesale change significantly complicates LIMS installations and might have poor acceptance and commitment support personnel to the project.

A similar problem often occurs in large organizations with dedicated Information System (IS) and departments. Significant conflict and problems can arise when IS personnel recommend the most up-to-date hardware or software architecture regardless of the functionality, fit or overall cost to the laboratory . The end result of this process is that the laboratory must undergo significant change in order to conform to product purchased. In the extreme case laboratories can wind-up having to increase overhead, e.g., more data handling, in order to use LIMS systems that have been designed not for the laboratory but for the accounting or production departments.

The keys to success are flexibility, adaptability, ease of evolution and support, and most importantly overall system speed. The speed issue is very critical, as bench personnel will not use something that is slow or awkward. If the system saves bench personnel time they will quickly “buy into” the project and aggressively move the process forward.

4 Installation Phase
The goal of any LIMS installation must be to acquire a system that will make the jobs of bench personnel easier and thus increase the efficiency of organization. In order to be successful, the LIMS system must be accepted and welcomed by the bench personnel. Often the first contact front-line personnel have with the new system is during installation, long after all decisions have been made. This situation often leads to significant software and LIMS configuration problems that require major software re-writes, hardware retro fits and/or disruptive organizational changes. In addition, analytical and support staff are more likely to resist the new system if they have had little input into its design and operational characteristics.

The installation phase of a LIMS program is critical to the overall success of the project. It is during LIMS installation that personnel must be taught how to use the product and where the software designers get their first view of how the LIMS will fit into the function in the laboratory. The installation phase of a LIMS project can take from weeks to months depending on the size of the laboratory and complexity of the project.

5 Conclusion
The time for a laboratory to move from manual tracking systems to a LIMS has never been better. Today’s LIMS include affordable and advanced database functionality that was not available in the past. These functions include the ability to seamlessly integrate laboratory information with common software such as the Professional Microsoft Office Suite (Word, Excel, Access, and PowerPoint) and other applications such as WordPerfect, and QuatroPro. The emergence of non-proprietary database systems allows end-users to customize reports, analyze and present their data in a number of ways. A successfully implemented LIMS will increases productivity of the laboratory improve accuracy of the data , decrease the number of mundane tasks performed and increase the overall efficiency of the laboratory.

LIMS的历史、发展、应用和实施应用
1. 历史
二十世纪八十年代，实验室工作全部由手工操作完成。工作人员手工管理样品、分析并比较结果。当数量众多的样品需要分析检测、并要求快速得出结果时，手工检测系统就显得无能为力了。于是一些专业人员开始编写小型软件程序管理日常实验室工作。随着商业和法规需求的增长，越来越多的实验室开始使用更加大型的程序管理工作，实验室进入自动化时期，但这时的软件水平还比较滞后。
当时，市场上出现了以商业为目的的实验室应用系统，尽管与如今的软件相比它们还处于初级水平，但得到了广泛应用，因为它们能为技术人员减轻大量繁重的工作。数年后软件水平提高了，而且随着WINDOWS操作系统的引入，应用软件的功能变得更加强大。LIMS最早出现在二十世纪八十年代，大多数早期的系统使用微机和具有优先级数据库配置的分级数据库结构。然而它们存在着严重的弊病，即价格昂贵、使用不便，无法从LIMS中直接读取数据。这以后便出现了带有相同数据库结构和优先级数据库配置的个人电脑。九十年代初期，WINDOWS的使用越来越广泛，但是LIMS供应商无法把复杂的应用从DOS或UNIX转成WINDOWS操作环境。 目前大多数的LIMS系统使用（ISAM）数据库，如小型实验室使用Microsoft Access，大型系统基本上是基于UNIX和SQL，如Oracle和Microsoft SQL Server。
2.LIMS的发展
首先，什么是LIMS？LIMS是专为研发实验室、中试实验室、质保（QA）实验室等分析型实验室设计的信息管理系统。通常情况下，LIMS把一个或更多的工作站或个人电脑与实验室中的分析仪器连接起来。这些仪器如色谱仪可以采集数据，仪器接口可把数据从色谱仪传到电脑里，然后由电脑处理数据，得出重要信息。这些信息可根据报告的要求被进一步分类、整理成不同的报表。
大多数LIMS产品可帮助实验室进行样品登记，指定样品所需分析，打印分析报表，监控化验截止日期，安排分析检测，获取并储存分析数据，监控分析质量，为客户送交的产品审核分析数据，打印并储存分析报告和发票，保证数据安全，跟踪样品，给样品分配库位，跟踪并交换实验室的质控信息，进行生产和财务统计，成本核算，管理客户信息，如名字、地址、销售数据等等。一个设计、安装优良的LIMS能迅速、准确、方便地处理实验室中的样品和数据。LIMS的真正价值在于能最大限度地处理样品量并降低劳动成本。
提高实验室生产力的各种方法中最有效的是通过在线仪器输入数据，这样可以明显降低数据输入的错误率。总之，最新的数据可以使实验室的监督和技术人员更好地安排分析工作，最大限度地缩短停工期，提高批量。另外，LIMS还可以加强对质控检查和数据处理的透明度。监控、跟踪和交换数据及质控信息的能力可以改进实验室分析方法、提高工作能力，其最终效果就是技术人员能在每单位时间内处理更多的样品。
LIMS自身在不断发展着，对LIMS功能的特殊需求促使LIMS也介入了基因研究、生物信息工程和MES（制造执行系统）集成等领域。LIMS供应商正在为大型合作用户开发客户化模块，现已有客户关系管理、HPLC数据管理、化学库存和设备校验管理等模块。
LIMS与ERP和MES等大型应用的集成已司空见惯，另外，LIMS也允许外部实验室客户通过英特网访问该系统、实时浏览分析检测结果，从而有效地扩展了实验室的自身功能。
3． 设计和实施
    在LIMS的设计阶段，厂家和软件供应商要对现有的软、硬件及自身实验室的需求文档进行分析评审。在这里容易疏忽的地方就是没有让实验室技术人员参与评审，因此建议经常与将要用到LIMS的技术人员开会讨论和沟通。
一些将要上LIMS的实验室认为将来会减少或取消对技术人员水平的监督工作。许多人认为LIMS只是个工具而已，无法管理实验室或代替监管人员的工作；而实际上LIMS能有效、及时地提供可靠而完整的操作数据。方便地读取正确的数 据可以显著提高管理者的决策质量和速度。（俗话说拿事实说话，所以）决策的形成更多地依赖事实而非本能感觉。
一般的专业软件人员通常对实验室的需求并不了解，这说明LIMS并非能轻而易举地与实验室的工作相匹配，实验室必须经常改变一些工作流程来适应LIMS。这种大规模变更会使LIMS的安装变得极为复杂，而且不易得到项目执行人员的认可。
类似的问题经常出现在拥有专业信息系统（IS）的大型组织和部门里。当IS人员推荐使用最新的硬件或软件时，如果忽视对其功能、适用性或整体成本的考虑，就容易出问题，甚至最终导致实验室必须重新改造来满足所采购的软件产品。只有在特殊情况下，为了使用不是为实验室而是为财务或生产部门设计的LIMS系统，实验室才会增加管理费用，如更多的数据处理。
优质软件关键要具有灵活性、适用性、可扩展性和良好的技术支持，而且最重要的是整体系统的运行速度。速度之所以至关重要是因为：实验室技术人员绝不会使用速度慢或难以应用的系统。如果软件系统能提高工作效率，技术人员会毫不犹豫地选择它以推进整个工作的进行。 LIMS的开发宗旨应该是：实现预期的功能而不影响系统运行速度。在充分发挥LIMS优势之前，实验室先要掌握LIMS的使用方法。为不影响程序的顺利运行，要经过一段磨合期，所以更多复杂的功能通常要推迟一或两年实现。这种方案延后实施的做法会让实验室人员在系统进入最后优化的关键阶段更多地参与进来。
4.安装
安装LIMS的目的是让它简化技术人员的工作，提高机构的效率。为了能成功地实施，LIMS系统先必须事先得到技术人员的认可和欢迎；而情况往往相反，即在安装阶段及所有决定做出之后，系统安装人员才与新系统环境下的一线人员进行首次接触。这种情况经常导致重要软件和LIMS出现设置问题，需要重新编写重要程序，重新安装硬件并/或进行机构改革。另外，实验室的分析和技术支持人员如果没有参与软件的功能和操作设计，就容易对新系统都产生抵触心理。
LIMS程序的安装阶段对整体项目的成功实施举足轻重。技术人员必须在安装阶段学会使用LIMS。 LIMS项目的安装周期可以从数周到数月，这取决于实验室的规模大小和项目的复杂程度。最近，中国政府把LIMS视为提高国内制造品质量和竞争力的主要手段之一。
5.结论
    现在正是用LIMS替换手工操作系统的大好时机！如今，LIMS已具有先进的数据库功能，这在以前是无法比拟的。这些功能包括把实验室信息与普通软件如微软办公系统（Word, Excel, Access, PowerPoint）及其他应用，如WordPerfect, QuatroPro, 进行无缝连接。非优先级的数据库系统可以让最终用户自定义报表和分析，并用多种方法提交数据。成功实施的LIMS将提高实验室生产力，提高数据的准确性，减少一些无谓的劳动，从而提高整个实验室的工作效率。