ASTM E1578 - 13

    Standard Guide for Laboratory Informatics

    Active Standard ASTM E1578 | Developed by Subcommittee: E13.15

    Book of Standards Volume: 03.06


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    Significance and Use

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

    4.1.1 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; and

    4.1.7 Provide high-level guidance for the integration of laboratory informatics.

    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.

    4.2.1 It is intended to be used throughout the laboratory informatics life cycle by individuals or groups responsible for laboratory informatics including specification, build/configuration, validation, use, upgrades, retirement/decommissioning.

    4.2.2 It is also intended to provide an example of a laboratory informatics functions checklist.

    1. Scope

    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).

    Note 1Laboratory informatics scope encompasses multiple technical solutions or systems. The division between these system categories continues to soften as functionality continues to be added to each of them. LIMS were originally created to address the laboratories’ need to manage laboratory operations and data, provide traceability for all laboratory samples and equipment, and ensure that laboratory procedures are followed. ELNs, on the other hand, were originally created to meet the scientists’ need to document their experimental design, execution, and conclusions in an electronic format instead of in a paper notebook. SDMS was created to provide a repository of all scientific data files and results regardless of instrument type. The current definitions of each of these system categories are far more encompassing.

    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:

    1.5.1 General Laboratories:

    1.5.1.1 Standards (ASTM, IEEE, ISO), and

    1.5.1.2 Government (EPA, FDA, JPL, NASA, NRC, USDA, FERC).

    1.5.2 Environmental:

    1.5.2.1 Environmental Monitoring.

    1.5.3 Life Science Laboratories:

    1.5.3.1 Biotechnology, and

    1.5.3.2 Diagnostic.

    1.5.4 Healthcare Medical:

    1.5.4.1 Devices,

    1.5.4.2 Pharmaceuticals vet/animal,

    1.5.4.3 Public health, and

    1.5.4.4 Hospital LIS.

    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, and

    1.5.5.4 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, and

    1.5.6.4 Food service and hospitality.

    1.5.7 Public Sector Laboratories:

    1.5.7.1 Law enforcement,

    1.5.7.2 State and local government,

    1.5.7.3 Education, and

    1.5.7.4 Public utilities (water, electric, waste treatment).

    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.

    1.7.1 The product lifecycle 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 lifecycle 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 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.


    2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

    ASTM Standards

    E1340 Guide for Rapid Prototyping of Information Systems

    E2066 Guide for Validation of Laboratory Information Management Systems

    FDA Regulation

    FDA21CFRPart11 Electronic Records, Electronic Signatures Final Rule, 62 Federal Register 13464, March 20, 1997

    GAMP

    GAMP5 Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture, ISPE, 2008

    ICH Standard

    ICHQualityGuidelineQ Quality Risk Management


    ICS Code

    ICS Number Code 35.240.80 (IT applications in health care technology)

    UNSPSC Code

    UNSPSC Code


    DOI: 10.1520/E1578

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