1.1本指南涵盖了实验室信息管理系统从启动到退役的生命周期各个阶段中常见的问题。以下小节详细介绍了本文件在特定领域的范围。 1.2高层次目的本指南的目的包括:（1）帮助教育实验室信息管理系统（LIMS）的新用户，（2）提供LIMS供应商和最终用户可以使用的标准术语，（3）制定LIMS主要功能的最低要求，（4）提供规范、评估、成本论证、实施、项目管理、，培训和文件，以及（5）提供LIMS功能清单示例。 1.3 LIMS定义实验室信息管理系统（LIMS）一词描述了设计用于管理实验室信息的计算机系统类别。 1.4实验室类别采用直线感应电机的实验室范围广泛。以下分类概述了使用LIMS的实验室类别以及每个类别中的实验室示例。 1.4.1一般实验室 标准（ASTM、IEEE、ISO）和 政府（EPA、FDA、JPL、NASA、NRC、USDA、FERC）。 1.4.2环境 环境监测。 1.4.3生命科学实验室 生物技术， 诊断的， 医疗保健， 设备，以及 药物兽医/动物。 1.4.4重工业实验室 能源， 制造施工， 材料和化学品 运输和装运。 1.4.5食品饮料实验室 农业 饮料， 食物，以及 餐饮服务热情。 1.4.6公共部门实验室 执法， 州地方政府， 教育，以及 公用事业（水、电、废物处理）。 1.4.7实验室规模 本指南涵盖了一系列实验室规模的LIMS主题，从具有简单要求的小型实验室到具有复杂要求的大型多站点/全球实验室。尽管本指南解决了主要影响大型LIMS实施的复杂问题，但各种规模的实验室都会发现本指南很有用。本指南中列出的实施时间和建议针对中型和大型实验室。 1.5 LIMS与其他外部系统（文件管理、色谱数据系统、实验室仪器、光谱数据系统、企业资源规划（ERP）、制造执行系统（MES）、纠正措施和预防措施（CAPA）之间的集成，电子实验室笔记本（ELN）和数据归档）为任何实验室提供了显著的商业利益。 本指南从较高的层次讨论了LIMS和其他外部系统之间的集成，包括数据交换和XML标准。 1.6生命周期阶段本指南中描述的LIMS生命周期包括以下阶段:（1）项目启动，（2）需求分析，（3）设计，（4）构建/配置，（5）测试和调试，（6）运行和维护，以及（7）退役。本指南旨在为每项活动提供LIMS系统生命周期和良好实践的理解。 它将帮助首次LIMS实施者规划和管理其LIMS项目，而经验丰富的LIMS用户可以使用LIMS系统生命周期来维护现有LIMS，并为下一代LIMS的实施做好准备。 1.7受众本指南的制定考虑了以下利益相关者的需求:（1）LIMS的最终用户，（2）LIMS的实施者，（3）质量人员，（4）信息技术人员，（5）LIMS供应商，（6）仪器供应商，（7）必须批准LIMS资金的个人，（8）LIMS应用支持专家，以及（9）软件测试/验证专家。 本指南中包含的信息将使广大实验室工作人员或与实验室互动的人员受益。新的LIMS用户可以使用本指南了解LIMS的目的和功能。该指南还可以帮助潜在LIMS用户理解术语、配置、功能、设计、优点和成本。购买LIMS的个人可以使用本指南确定针对特定实验室环境推荐的功能。商业LIMS供应商的研发人员可以使用该指南作为工具来评估、识别和潜在地改进其产品的能力。 LIMS供应商销售人员可以使用本指南以更通用和产品中性的术语向潜在客户介绍其LIMS产品的功能。 1.8超出范围本指南中提及的系统在LIMS接口范围内的完整描述和使用超出了本标准的范围。这些系统的示例包括色谱数据系统（CDS）、电子实验室笔记本（ELN）、数据归档、科学数据管理系统（SDMS）、企业资源规划（ERP）、制造执行系统（MES）和电子文档管理系统（EDMS）。 ====意义和用途====== 关联 — 本指南旨在就LIMS的许多方面对目标受众进行教育。具体而言，《指南》可以: 4.1.1帮助教育LIMS的新用户； 4.1.2帮助在实验室和其他使用LIMS的组织中教育普通受众； 4.1.3帮助教育其他常用接口系统的仪器制造商和生产商； 4.1.4提供LIMS供应商和最终用户可以使用的标准术语； 4.1.5为主要LIMS功能制定最低要求； 4.1.6对LIMS规范、评估、成本论证、实施、项目管理、培训和文件中执行的任务和创建的文件提供指导；和 4.1.7为LIMS与最常见的集成系统（如实验室仪器、CDS、ERP、ELN、SDMS等）的集成提供高级指导。 如何使用 — 本指南旨在供参与LIMS实施或维护任何方面的所有利益相关者使用。 4.2.1其旨在由负责LIMS的个人或团体在LIMS的整个生命周期内使用，包括规范、构建/配置、验证、使用、升级、退役/退役。 4.2.2还旨在提供LIMS功能检查表的示例。

1.1 This guide covers issues commonly encountered at all stages in the life cycle of Laboratory Information Management Systems from inception to retirement. The sub-sections that follow describe details of scope of this document in specific areas. 1.2 High Level PurposeThe purpose of this guide includes: (1) help educate new users of Laboratory Information Management Systems (LIMS), (2) provide standard terminology that can be used by LIMS vendors and end users, (3) establish minimum requirements for primary LIMS functions, (4) provide guidance for the specification, evaluation, cost justification, implementation, project management, training, and documentation, and (5) provide an example of a LIMS function checklist. 1.3 LIMS DefinitionThe term Laboratory Information Management Systems (LIMS) describes the class of computer systems designed to manage laboratory information. 1.4 Laboratory CategoriesThe spectrum of laboratories that employ LIMS is wide spread. The following break down provides an overview of the laboratory categories that use LIMS as well as examples of laboratories in each category. 1.4.1 General Laboratories Standards (ASTM, IEEE, ISO), and Government (EPA, FDA, JPL, NASA, NRC, USDA, FERC). 1.4.2 Environmental Environmental Monitoring. 1.4.3 Life Science Laboratories Biotechnology, Diagnostic, Healthcare Medical, Devices, and Pharmaceuticals Vet/Animal. 1.4.4 Heavy Industry Laboratories Energy Resources, Manufacturing Construction, Materials Chemicals, and Transportation Shipping. 1.4.5 Food Beverage Laboratories Agriculture, Beverages, Food, and Food Service Hospitality. 1.4.6 Public Sector Laboratories Law Enforcement, State Local Government, Education, and Public Utilities (Water, Electric, Waste Treatment). 1.4.7 Laboratory Size This guide covers topics regarding LIMS for a range of laboratory sizes ranging from small with simple requirements to large multi-site/global laboratories with complex requirements. Although the guide addresses complex issues that impact primarily large LIMS implementations, laboratories of all sizes will find this guide useful. The implementation times and recommendations listed in this guide are directed at medium and large laboratories. 1.5 IntegrationIntegration between LIMS and other external systems (document management, chromatography data systems, laboratory instruments, spectroscopic data systems, Enterprise Resource Planning (ERP), Manufacturing Execution Systems (MES), Corrective Action and Preventative Action (CAPA), Electronic Laboratory Notebooks (ELNs) and data archive) provides significant business benefits to any laboratory. Integration between LIMS and other external systems is discussed at a high level in this guide including data interchange and XML standards. 1.6 Lifecycle PhasesThe LIMS lifecycle described in this guide includes the following phases: (1) project initiation, (2) requirements analysis, (3) design, (4) build/configure, (5) test and commission, (6) operation and maintenance, and (7) retirement. This guide is intended to provide an understanding of the LIMS system life cycle and good practices for each of the activities. It will help first time LIMS implementers plan and manage their LIMS projects while seasoned LIMS users may use the LIMS system life cycle to maintain existing LIMS and prepare for the implementation of the next generation LIMS. 1.7 AudienceThis guide has been created with the needs of the following stakeholders in mind: (1) end users of LIMS, (2) implementers of LIMS, (3) quality personnel, (4) information technology personnel, (5) LIMS vendors, (6) instrument vendors, (7) individuals who must approve LIMS funding, (8) LIMS application support specialists, and (9) software test/validation specialist. Information contained in this guide will benefit a broad audience of people who work or interact with a laboratory. New LIMS users can use this guide to understand the purpose and functions of LIMS. The guide can also help prospective LIMS users in understanding terminology, configurations, features, design, benefits and costs. Individuals who are purchasing a LIMS may use this guide to identify functions that are recommended for specific laboratory environments. Research and Development staff of commercial LIMS vendors may use the guide as a tool to evaluate, identify, and potentially improve the capabilities of their products. LIMS vendor sales staff may use the guide to represent functions of their LIMS product to prospective customers in more generic and product neutral terms. 1.8 Out of ScopeThe full description and use of systems mentioned in this guide within the context of interfaces to LIMS are beyond the scope of this standard. Examples of these systems include Chromatography Data Systems (CDS), Electronic Laboratory Notebooks (ELN), Data Archive, Scientific Data Management Systems (SDMS), Enterprise Resource Planning (ERP), Manufacturing Execution Systems (MES) and Electronic Document Management Systems (EDMS). ====== Significance And Use ====== Relevance — This guide is intended to educate those in the intended audience on many aspects of LIMS. Specifically, the guide may: 4.1.1 Help educate new users of LIMS; 4.1.2 Help educate general audiences in laboratories and other organizations that use LIMS; 4.1.3 Help educate instrument manufactures and producers of other commonly interfaced systems; 4.1.4 Provide standard terminology that can be used by LIMS vendors and end users; 4.1.5 Establish a minimum set of requirements for primary LIMS functions; 4.1.6 Provide guidance on the tasks performed and documentation created in the specification, evaluation, cost justification, implementation, project management, training, and documentation of LIMS; and 4.1.7 Provide high-level guidance for the integration of LIMS with the most commonly integrated systems such as laboratory instruments, CDS, ERP, ELN, SDMS and so forth. How Used — This guide is intended to be used by all stakeholders involved in any aspect of LIMS implementation or maintenance. 4.2.1 It is intended to be used throughout the LIMS life cycle by individuals or groups responsible for LIMS including specification, build/configuration, validation, use, upgrades, retirement/decommissioning. 4.2.2 It is also intended to provide an example of a LIMS function checklist.