ASTM E1578-13

4.1 Relevance—This guide is intended to educate those in the intended audience on many aspects of laboratory informatics. Specifically, the guide may:

4.2 How Used—This guide is intended to be used by all stakeholders involved in any aspect of laboratory informatics implementation, use or maintenance.

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).

1.5 The scope of this guide covers a wide range of laboratory types, industries, and sizes. Examples of laboratory types and industries are listed in the following:

1.6 Integration—The scope 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 absolution. 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 tool(s) to the existing one(s) in today’s evolving laboratory informatics world adds constraints that need to be considered. The lifecycle discussion includes both the laboratory informatics solution lifecycle as well as the project lifecycle, which describes steps to a laboratory informatics solution.

1.8 Audience—This guide has been created with the needs of the following stakeholders in mind: 1.9 Out of Scope—This guide does not attempt to define the boundaries, as they continue to evolve, between the different types of laboratory informatics but rather focuses on the functionality that is provided by laboratory informatics as a whole.