ASTM E1578-13

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), 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 sub-sections that follow describe details of scope of this document in specific areas.

1.2 High-Level Purpose—The purpose of this guide includes: (1) helping educate new users of laboratory informatics tools, (2) provide a standard terminology that can be used by different vendors and end users, (3) establish minimum requirements for laboratory informatics, (4) provide guidance for the specification, evaluation, cost justification, implementation, project management, training, and documentation of the systems, and (5) provide function checklist examples for laboratory informatics systems that can be adopted within the laboratory and integrated with the 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 supporting processes. Laboratory informatics includes the integration of systems, the electronic delivery of results to customers, and the supporting systems including training and policies. Examples of laboratory informatics include: Laboratory Information Management Systems (LIMS), Electronic Laboratory Notebooks (ELNs), Chromatography Data Systems (CDS), and Scientific Data Management Systems (SDMS).

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 process and manage their data. Selection of an informatics solution requires a detailed analysis of the laboratory’s requirements rather than by choosing a product category. It is important to include representatives from Information Technology (IT) and Subject Matter Experts (SMEs), who understand the needs of the laboratory, to be involved in the selection and implementation of a laboratory informatics system to ensure that the needs of the laboratory are met and that IT can support it. Customers (internal and external) of laboratory information should also be included in the laboratory informatics solution design, to ensure there is full electronic integration between systems.