【国外标准】 Standard Guide for Laboratory Informatics

4.1 Relevance—This guide is intended to educate the intended audience on many aspects of laboratory informatics. Specifically, the guide may:4.1.1 Help educate new users of laboratory informatics;4.1.2 Help educate general audiences in laboratories and other organizations that use laboratory informatics;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 laboratory informatics vendors and end users;4.1.5 Establish a minimum set of requirements for primary laboratory informatics 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 laboratory informatics; and4.1.7 Provide high-level guidance for the integration of laboratory informatics and other software tools.4.2 How to be Used—This guide is intended to be used by all stakeholders involved in any aspect of laboratory informatics implementation, use, or maintenance.4.2.1 It is intended to be used throughout the laboratory informatics life cycle by individuals or groups responsible for laboratory informatics implementation and use, including specification, build/configuration, validation, use, upgrades, and retirement/decommissioning.4.2.2 This guide also provides an example of a laboratory informatics functional requirements checklist that can be used to guide the purchase, upgrade, or development of a laboratory informatics system.1.1 This guide helps describe the laboratory informatics landscape and covers issues commonly encountered at all stages in the life cycle of laboratory informatics from inception to retirement. It explains the evolution of laboratory informatics tools used in today’s laboratories such as laboratory information management systems (LIMS), laboratory execution systems (LES), laboratory information systems (LIS), electronic laboratory notebooks (ELN), scientific data management systems (SDMS), and chromatography data systems (CDS). It also covers the relationship (interactions) between these tools and the external systems in a given organization. The guide discusses supporting laboratory informatics tools and a wide variety of the issues commonly encountered at different stages in the life cycle. The subsections that follow describe the scope of this document in specific areas.1.2 High-Level Purpose—The purpose of this guide includes: (1) educating new users on laboratory informatics tools; (2) providing a standard terminology that can be used by different vendors and end users; (3) establishing minimum requirements for laboratory informatics; (4) providing guidance for the specification, evaluation, cost justification, implementation, project management, training, and documentation of the systems; and (5) providing a functional requirements checklist for laboratory informatics systems that can be adopted within the laboratory and integrated with existing systems.1.3 Laboratory Informatics Definition—Laboratory informatics is the specialized application of information technology aimed at optimizing laboratory operations. It is a collection of informatics tools utilized within laboratory environments to collect, store, process, analyze, report, and archive data and information from the laboratory and its supporting processes. Laboratory informatics includes the effective use of critical data management systems, the electronic delivery of results to customers, and the use and integration of supporting systems (for example, training and policy management). Examples of primary laboratory informatics tools include laboratory information management systems (LIMS), laboratory execution systems (LES), laboratory information systems (LIS), electronic laboratory notebooks (ELN), scientific data management systems (SDMS), and chromatography data systems (CDS).1.4  Considerations when Selecting and Implementing Laboratory Informatics Solutions—Many laboratories have determined that they need to deploy multiple laboratory informatics systems to automate their laboratory processes and manage their data. Selection of an informatics solution requires a detailed analysis of the laboratory’s requirements and should not be a simple product category decision. Information technology (IT) representatives and subject matter experts (SMEs) who understand the needs of the laboratory need to be involved in the selection and implementation of a laboratory informatics system to ensure that the needs of the laboratory are met and IT can support it. Customers (internal and external) of laboratory information should also be included in the laboratory informatics solution design to ensure full electronic integration between systems.1.5 The scope of this guide covers a wide range of laboratory types, industries, and sizes. Examples of laboratory types and industries include:1.5.1 General Laboratories: 1.5.1.1 Standards (ASTM, IEEE, ISO) and1.5.1.2 Government (EPA, FDA, JPL, NASA, NRC, USDA, USGS, FERC).1.5.2 Environmental: 1.5.2.1 Environmental monitoring.1.5.3 Life Science Laboratories: 1.5.3.1 Biotechnology and1.5.3.2 Diagnostic.1.5.4 Healthcare and Medical: 1.5.4.1 Bionomics/genomics,1.5.4.2 Medical devices,1.5.4.3 Pharmaceutical,1.5.4.4 Veterinary,1.5.4.5 Public health, and1.5.4.6 Hospital.1.5.5 Heavy Industry Laboratories: 1.5.5.1 Energy and resources,1.5.5.2 Manufacturing and construction,1.5.5.3 Materials and chemicals, and1.5.5.4 Transportation and shipping.1.5.6 Food and Beverage Laboratories: 1.5.6.1 Agriculture,1.5.6.2 Beverages,1.5.6.3 Food, and1.5.6.4 Food service and hospitality.1.5.7 Public Sector Laboratories: 1.5.7.1 Law enforcement/forensic,1.5.7.2 State and local government,1.5.7.3 Education and nonprofits, and1.5.7.4 Public utilities (water, electric, waste treatment).1.6 Integration—The scope of integration covered in this guide includes communication and meaningful data exchange between different laboratory informatics tools and other external systems (document management, chromatography data systems, laboratory instruments, spectroscopy data systems, enterprise resource planning (ERP), manufacturing execution systems (MES), investigations/deviations and CAPA management systems), and other integrated business systems (for example, clinical or hospital environments) provide significant business benefits to any laboratory and is discussed at a high level in this guide.1.7 Life-Cycle Phases—The scope of this guide is intended to provide an understanding of laboratory informatics tools’ life cycle from project initiation point to retirement and decommissioning. This guide was designed to help newer audiences in understanding the complexity in the relationships between different laboratory informatics tools and how to plan and manage the implementation project, while seasoned users may use the different life cycles to maintain existing laboratory informatics tools. Integrating additional informatics tools to existing ones in today’s evolving laboratory environment adds constraints that need to be considered. The life-cycle discussion includes both the laboratory informatics solution life cycle as well as the project life cycle.1.7.1 The product life cycle encompasses a specific laboratory informatics system and the expected useful life of that system before it needs to be replaced or upgraded.1.7.2 The project life cycle encompasses the activities to acquire, implement, operate, and eventually retire a specific laboratory informatics system.1.8 Audience—This guide has been created with the needs of the following stakeholders in mind: (1) end users of laboratory informatics tools, (2) implementers of laboratory informatics tools, (3) quality personnel, (4) information technology personnel, (5) laboratory informatics tools vendors, (6) instrument vendors, (7) individuals who approve laboratory informatics tools funding, (8) laboratory informatics applications support specialists, and (9) software test/validation specialists. Information contained in this guide will benefit a broad audience of people who work in or interact with a laboratory. New users can use this guide to understand the purpose and functions of the wide variety of laboratory informatics tools as well as the interactions between these tools with external systems. The guide can also help prospective users in understanding terminology, configurations, features, design, benefits, and costs of these different laboratory informatics tools. Individuals who are purchasing specific tools may also use this guide to identify functions that are recommended for specific laboratory environments. Research and development staff of different commercial laboratory informatics systems vendors may use the guide as a tool to evaluate, identify, and potentially improve the capabilities of their products. The vendors’ sales staff may use the guide to represent functions of their laboratory informatics products to prospective customers in more generic and product-neutral terms.1.9 Out of —This guide does not attempt to define the boundaries of laboratory informatics, as they continue to evolve and blur between the different types of tools; rather, it focuses on the functionality that is provided by laboratory informatics as a whole.1.10 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.