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.

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) 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 shall 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 or interact with a laboratory. New users can use this guide to understand the purpose and functions of the wide varieties 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 (a) specific tool(s) 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 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.