1.1本指南描述了用于管理实验室信息的计算机系统。实验室信息管理系统（LIMS）一词描述了这类计算机系统。 1.2本指南涵盖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实验室的LIM。LIMS指南的要素可根据具体实验室要求进行选择。 1.3本文件的受众包括:（1）LIMS的最终用户，（2）LIMS的实施者，（3）LIMS供应商，（4）仪器供应商，以及（5）必须批准LIMS资金的个人。 1.4本指南的目的包括:（1）帮助培训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功能检查表的示例。 1.5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。该指南可以帮助潜在LIMS用户理解术语、配置、功能、设计和成本。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。LIMS供应商研发人员可以使用该指南作为工具来评估、识别和纠正需要改进的领域。LIMS供应商销售人员可以使用该指南向潜在客户准确表示其LIMS产品的功能。 本指南未定义实验室仪器接口。 1.6本指南适用于所有规模的实验室。该指南解决了主要影响大型LIMS实施的复杂问题。小型实验室应审查可能影响其环境的问题。本指南中列出的实施时间和建议针对中型和大型实验室。

1.1 This guide describes computer systems used to manage laboratory information. The term Laboratory Information Management Systems (LIMS) describes this class of computer systems. 1.2 This guide covers LIMS ranging from small laboratories with simple requirements to large multi-site laboratories with complex requirements. The elements of the LIMS guide may be selected based on specific laboratory requirements. 1.3 The audience of this document includes: (1) end users of LIMS, (2) implementers of LIMS, (3) LIMS vendors, (4) instrument vendors, and (5) individuals who must approve LIMS funding. 1.4 The 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. 1.5 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 help prospective LIMS users in understanding terminology, configurations, features, design, and costs. Individuals who are purchasing a LIMS can use this guide to identify functions that are recommended for specific laboratory environments. LIMS vendor Research and Development staffs can use the guide as a tool to evaluate, identify, and correct areas that need improvement. LIMS vendor sales staffs can use the guide to accurately represent functions of their LIMS product to prospective customers. This guide does not define laboratory instrument interfaces. 1.6 This guide can be used by laboratories of all sizes. The guide addresses complex issues that impact primarily large LIMS implementations. Small laboratories should review issues that may impact their environments. The implementation times and recommendations listed in this guide are directed at medium and large laboratories.