ASTM E1578-18

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 Scope 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: