ASTM E1578-13
(Guide)Standard Guide for Laboratory Informatics
Standard Guide for Laboratory Informatics
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.
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 1—Laboratory 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 sam...
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Designation: E1578 − 13
Standard Guide for
1
Laboratory Informatics
This standard is issued under the fixed designation E1578; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope Chromatography Data Systems (CDS), and Scientific Data
Management Systems (SDMS).
1.1 This guide helps describe the laboratory informatics
NOTE 1—Laboratory informatics scope encompasses multiple technical
landscape and covers issues commonly encountered at all
solutions or systems. The division between these system categories
stagesinthelifecycleoflaboratoryinformaticsfrominception
continues to soften as functionality continues to be added to each of them.
to retirement. It explains the evolution of laboratory informat-
LIMS were originally created to address the laboratories’need to manage
laboratory operations and data, provide traceability for all laboratory
ics tools used in today’s laboratories such as Laboratory
samples and equipment, and ensure that laboratory procedures are
Information Management Systems (LIMS), Electronic Labora-
followed. ELNs, on the other hand, were originally created to meet the
tory Notebooks (ELN), Scientific Data Management Systems
scientists’ need to document their experimental design, execution, and
(SDMS), and Chromatography Data Systems (CDS). It also
conclusions in an electronic format instead of in a paper notebook. SDMS
covers the relationship (interactions) between these tools and
was created to provide a repository of all scientific data files and results
regardless of instrument type. The current definitions of each of these
the external systems in a given organization. The guide
system categories are far more encompassing.
discusses supporting laboratory informatics tools and a wide
variety of the issues commonly encountered at different stages 1.4 Scope Considerations When Selecting and Implement-
in the life cycle. The sub-sections that follow describe details ing Laboratory Informatics Solutions—Manylaboratorieshave
of scope of this document in specific areas. determined that they need to deploy multiple laboratory
informatics systems to automate their laboratory process and
1.2 High-Level Purpose—The purpose of this guide in-
managetheirdata.Selectionofaninformaticssolutionrequires
cludes: (1)helpingeducatenewusersoflaboratoryinformatics
a detailed analysis of the laboratory’s requirements rather than
tools, (2) provide a standard terminology that can be used by
by choosing a product category. It is important to include
different vendors and end users, (3) establish minimum re-
representatives from Information Technology (IT) and Subject
quirementsforlaboratoryinformatics, (4)provideguidancefor
Matter Experts (SMEs), who understand the needs of the
thespecification,evaluation,costjustification,implementation,
laboratory, to be involved in the selection and implementation
project management, training, and documentation of the
of a laboratory informatics system to ensure that the needs of
systems, and (5) provide function checklist examples for
the laboratory are met and that IT can support it. Customers
laboratory informatics systems that can be adopted within the
(internalandexternal)oflaboratoryinformationshouldalsobe
laboratory and integrated with the existing systems.
included in the laboratory informatics solution design, to
1.3 Laboratory Informatics Definition—Laboratory infor-
ensure there is full electronic integration between systems.
matics is the specialized application of information technology
1.5 The scope of this guide covers a wide range of labora-
aimed at optimizing laboratory operations. It is a collection of
tory types, industries, and sizes. Examples of laboratory types
informatics tools utilized within laboratory environments to
and industries are listed in the following:
collect, store, process, analyze, report, and archive data and
1.5.1 General Laboratories:
information from the laboratory and supporting processes.
1.5.1.1 Standards (ASTM, IEEE, ISO), and
Laboratory informatics includes the integration of systems, the
1.5.1.2 Government(EPA,FDA,JPL,NASA,NRC,USDA,
electronic delivery of results to customers, and the supporting
FERC).
systems including training and policies. Examples of labora-
1.5.2 Environmental:
tory informatics include: Laboratory Information Management
1.5.2.1 Environmental Monitoring.
Systems (LIMS), Electronic Laboratory Notebooks (ELNs),
1.5.3 Life Science Laboratories:
1.5.3.1 Biotechnology, and
1.5.3.2 Diagnostic.
1
This guide is under the jurisdiction of ASTM Committee E13 on Molecular
Spectroscopy and Separation Science and is
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: E1578 − 06 E1578 − 13
Standard Guide for
Laboratory Information Management Systems
1
(LIMS)Informatics
This standard is issued under the fixed designation E1578; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
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 from inception to retirement. The (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 High-Level Purpose—The purpose of this guide includes: (1) helphelping educate new users of Laboratory
Information Management Systems (LIMS), laboratory informatics tools, (2) provide a standard terminology that can be used by
LIMSdifferent vendors and end users, (3) establish minimum requirements for primary LIMS functions, laboratory informatics, (4)
provide guidance for the specification, evaluation, cost justification, implementation, project management, training, and
documentation, documentation of the systems, and (5) provide an example of a LIMS function checklist.function checklist
examples for laboratory informatics systems that can be adopted within the laboratory and integrated with the existing systems.
1.3 LIMS Laboratory Informatics Definition—The term Laboratory 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) describes the class of computer systems designed to manage laboratory information.(LIMS),
Electronic Laboratory Notebooks (ELNs), Chromatography Data Systems (CDS), and Scientific Data Management Systems
(SDMS).
NOTE 1—Laboratory 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 includ
...
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