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| [[File:PCR machine.jpg|thumb|right|A Bio-Rad thermal cycler as an example of a [[laboratory]] device that measures, processes, and sends information]]'''Laboratory informatics''' is the specialized application of information through a platform of instruments, software, and data management tools that allow scientific data to be captured, migrated, processed, and interpreted for immediate use, as well as stored, managed, and shared to support future research, development, and lab testing efforts while maximizing the efficiency of [[laboratory]] operations.<ref name="LM08Informatics">{{cite web |url=https://www.labmanager.com/laboratory-informatics-20964 |title=Informatics Are Really, Really, Really Important |author=Metrick, G. |work=Lab Manager Magazine |date=20 July 2008 |accessdate=27 March 2024}}</ref><ref name="CLIPaper">{{cite web |url=https://www.it.uu.se/edu/course/homepage/lims/vt12/ComprehensiveLaboratoryInformatics.pdf |archiveurl=https://web.archive.org/web/20170825181932/https://www.it.uu.se/edu/course/homepage/lims/vt12/ComprehensiveLaboratoryInformatics.pdf |format=PDF |title=Comprehensive Laboratory Informatics: A Multilayer Approach |author=Wood, S. |work=American Laboratory |date=September 2007 |pages=3 |archivedate=25 August 2017 |accessdate=27 March 2024}}</ref>
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| ==History==
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| The term "laboratory informatics" has been in use at least since the early 1980s<ref name="ExcerptaMedica">{{cite journal |url=https://books.google.com/books?id=z4GaAAAAIAAJ&q=%22laboratory+informatics%22&dq=%22laboratory+informatics%22&hl=en |journal=Excerpta Medica |title=Section 36: Health Economics and Hospital Management |volume=19 |issue=1 |year=1983 |page=72, 534}}</ref><ref name="NewSciLI">{{cite journal |url=https://books.google.com/books?id=uyceAQAAMAAJ&q=%22laboratory+informatics%22&dq=%22laboratory+informatics%22&hl=en |work=New Scientist |title=Research |publisher=New Science Publications |volume=109 |year=1986 |page=66}}</ref><ref name="InfoPath">{{cite journal |url=https://books.google.com/books?id=PbNYAAAAYAAJ&q=%22laboratory+informatics%22&dq=%22laboratory+informatics%22&hl=en |work=Informatics in Pathology |title=Introduction |publisher=Grune & Stratton |volume=1 |issue=1 |year=1986 |page=1}}</ref> and has expanded in meaning since then. Before the advent of computer technology, [[information management]] played an important role in laboratories and research efforts of all sorts. And while today the process of information management continues to be important, laboratory informatics tends to focus more on the technology and [[workflow]]s associated with that information management process.<ref name="InfoClinLab">{{cite book |url=https://books.google.com/books?id=OKqGfr6xgFkC&pg=PA9 |title=Informatics for the Clinical Laboratory: A Practical Guide |editor=Cowan, D. |year=2002 |pages=9 |edition=1st |publisher=Springer |isbn=9780387244495}}</ref>
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| The field itself is one which has seen significant growth as demand for fast and efficient electronic data exchange has boomed. A rapid series of technological developments have made laboratory equipment less static and more interactive, allowing large networks of integrated lab devices, computers, and telecommunications equipment to log, analyze, and distribute data. This has progressively enabled scientific research projects to move from a localized model to a more global model, one that allows "involved researchers to spend less time collecting data or waiting for information to arrive from another location, which in turn allows them to focus more on the work at hand and makes their research both faster and more efficient."<ref name="VI">{{cite web |url=http://www.virtualinformatics.com/content/Laboratory_informatics.htm |archiveurl=http://web.archive.org/web/20150425070143/http://virtualinformatics.com/content/Laboratory_informatics.htm |title=Laboratory Informatics |publisher=virtualinformatics.com |date=09 April 2011 |archivedate=25 April 2015 |accessdate=27 March 2024}}</ref> Tangentially, more robust and scalable data management systems have been developed to help laboratories stay competitive. Today, this often means adopting [[laboratory automation]] solutions that are capable of being developed and deployed in an agile fashion.<ref name="KrasovecLIMS09">{{cite journal |title=LIMS Get Agile |journal=International Clinical Trials |author=Krasovec, E. |volume=Spring 2009 |pages=32, 34 |year=2009 |url=https://www.informatics.abbott/shared/lims-get-agile.pdf |format=PDF |archiveurl=https://web.archive.org/web/20210126145540/https://www.informatics.abbott/shared/lims-get-agile.pdf |archivedate=26 January 2021 |accessdate=27 March 2024}}</ref><ref name="CSolsAgile19">{{cite web |url=https://www.csolsinc.com/blog/agile-development-in-laboratory-informatics/ |title=Agile Development in Laboratory Informatics |publisher=CSols, Inc. |date=05 December 2019 |accessdate=27 March 2024}}</ref> Additionally, the rapid rate of change in the technological (e.g., [[cloud computing]], big data) and operational needs (e.g., more automated [[workflow]]s) of researchers—coupled with growing competition—has led to a variety of related efforts, such as conferences and trade shows, to assist directors, managers, and researchers in better keeping up with the industry.<ref name="MetrickTrends10">{{cite web |url=https://www.labmanager.com/trends-in-laboratory-informatics-19119 |title=Trends in Laboratory Informatics |author=Metrick, G. |work=Lab Manager Magazine |date=08 December 2010 |accessdate=27 March 2024}}</ref>
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| Today, the concept of laboratory informatics continues to evolve, with market research groups like Gartner identifying need-based shifts towards multi-purpose solutions that address end-to-end management of laboratory data and operations.<ref name="ShanlerMarket21">{{cite web |url=https://www.gartner.com/en/documents/4004372 |title=Market Guide for Laboratory Informatics |author=Shanler, M.; Sinha, R. |publisher=Gartner, Inc |date=04 August 2021 |accessdate=27 March 2024}}</ref><ref name="AgiLabGartner21">{{cite web |url=https://www.agilab.com/gartner-market-guide-laboratory-informatics-2/ |title=Gartner Market Guide for Laboratory Informatics |publisher=AgiLab SAS |date=29 October 2021 |accessdate=27 March 2024}}</ref><ref name="ShanlerHype23">{{cite web |url=https://www.antaresvisiongroup.com/lifescience/wp-content/uploads/sites/3/2023/08/Hype_Cycle_for_Life__788244_ndx.pdf |format=PDF |title=Hype Cycle for Life Science Manufacturing, Quality and Supply Chain, 2023 |author=Shanler, M.; Franzosa, R.; Nieradka, M. |publisher=Gartner, Inc |date=27 July 2023 |accessdate=27 March 2024}}</ref><ref name="ThermoAccel23">{{cite web |url=https://assets.thermofisher.com/TFS-Assets/DSD/brochures/Thermo_RoleOfLIMSPlatform_EN.pdf |format=PDF |title=Accelerating science with a well-architected digital experience |publisher=Thermo Fisher Scientific, Inc |date=June 2023 |accessdate=27 March 2024}}</ref> This can be seen in developing concepts such as "enterprise laboratory informatics," which attempts to integrate laboratory informatics systems and functionality across an entire laboratory-supported enterprise, often through the use of a more unified, platform-based approach that uses future-focused software architectures to help reduce complexity, cost of ownership, and time to market while also improving efficiency and quality.<ref name="ShanlerHype23" /> This concept of unifying laboratory informatics systems and functionality into a more streamlined approach across an entire enterprise is most readily seen in laboratory-supported organizations that not only conduct research and development (R&D) activities but also manufacture their researched products.<ref name="ShanlerMarket21" /><ref name="AgiLabGartner21" /><ref name="ShanlerHype23" />
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| ==Sub-elements in laboratory informatics==
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| Laboratory informatics is often modeled as a central component or hub for other branching elements of the field. However, looking at the architecture in this fashion oversimplifies the field of laboratory informatics and risks giving the false appearance that branched elements of the field have greater importance than others. Instead, a multi-layered, non-hierarchical model of these elements that places an emphasis on an individual laboratory's identified business needs may be more appropriate.<ref name="CLIPaper" /> A cottage industry of businesses and consultants has developed from this philosophy, helping laboratories map their [[Informatics (academic field)|informatics]] needs to their corporate strategy.<ref name=">{{cite web |url=http://www.labvantage.com/services/laboratory-strategy.aspx |archiveurl=https://web.archive.org/web/20130213132659/http://www.labvantage.com/services/laboratory-strategy.aspx |title=Laboratory Informatics Strategy |publisher=Labvantage Solutions, Inc |archivedate=13 February 2013 |accessdate=27 March 2024}}</ref>
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| Yet it's difficult to deny the existence of branching elements of laboratory informatics. Many scientific pursuits require a laboratory, from medicine to astrophysics. This has led to special "sub-applications" of [[informatics]] to more specialized laboratories. [[Genome informatics]] developed as genetics laboratories sought more efficient ways to manage the large amounts of data being acquired from experiments and research. As scientists continue their pursuit of unlocking the secrets of the brain, [[neuroinformatics]] and its associated technology has developed to aid those researchers in their endeavors. And as hydrologists tackle the issues of equitable and efficient use of water for many different purposes, [[hydroinformatics]] and computational hydraulics have emerged.
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| These sub-applications of laboratory informatics are also discussed in [[ASTM International]]'s [[ASTM E1578|ASTM E1578-18]] ''Standard Guide for Laboratory Informatics''. Updated in mid-2019, the standard not only covers applications of informatics to general analytical laboratories but also to environmental, life science, medical, industrial, and public sector labs. The update brought with it new insights into laboratory informatics tools and how to integrate them into laboratory workflow, and with other hardware and software. And though relatively in their infancy in laboratory application, the revision added content about the application of the [[internet of things]] (IoT), [[artificial intelligence]] (AI), and smart objects to the laboratory.<ref name="ASTME1578">{{cite web |url=https://www.astm.org/e1578-18.html |title=ASTM E1578-18 Standard Guide for Laboratory Informatics |publisher=ASTM International |date=23 August 2019 |accessdate=27 March 2024}}</ref>
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| ===Additional considerations in laboratory informatics===
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| The actual processes (i.e., workflows) that involve information management in the laboratory should not be overlooked. Laboratories are usually required to meet regulatory requirements that dictate what data should be managed; when it should be collected and stored; how it should be collected, used, and stored; where it should be housed; and who has access to it.<ref name="MatsushitaCompl09">{{cite journal |title=Compliance with laboratory requirements regarding the secondary use of clinical specimens and laboratory data |journal=Rinsho Byori |author=Matsushita, H.; Miyachi, H. |volume=57 |issue=7 |pages=678–82 |year=2009 |pmid=19708538}}</ref><ref name="PoosaAnExpl15">{{cite web |url=http://www.bcsolutionsrfn.com/wp-content/uploads/2015/11/explanation-of-laboratory-governing-bodies-regulations-and-applicable-laws.pdf |archiveurl=https://web.archive.org/web/20200319213139/http://www.bcsolutionsrfn.com/wp-content/uploads/2015/11/explanation-of-laboratory-governing-bodies-regulations-and-applicable-laws.pdf |format=PDF |title=An Explanation of Laboratory Governing Bodies, Regulations, and Applicable Laws |author=Poosa, S. |publisher=BC Solutions, LLC |date=November 2015 |archivedate=19 March 2020 |accessdate=27 March 2024}}</ref> This type of regulation has, of course, had an impact on the development of software in general<ref name="Hamou-LhadjRegulatory10">{{cite journal |title=Regulatory Compliance and its Impact on Software Development |journal=Proceedings from the First Workshop on Law Compliancy Issues in Organisational Systems and Strategies (iComply10) |author=Hamou-Lhadj, A. |pages=1–5 |year=2010 |url=https://www.semanticscholar.org/paper/Regulatory-Compliance-and-its-Impact-on-Software-Hamou-Lhadj/033e3f4cb88026804d1de861b6e1944d652cbd74?p2df |format=PDF}}</ref><ref name="MiriComply18">{{cite journal |title=Complying With GDPR: An Agile Case Study |journal=ISACA Journal |author=Miri, M.; Foomany, F.H.; Mohammed, N. |volume=2 |pages=1–7 |year=2018 |url=https://www.isaca.org/resources/isaca-journal/issues/2018/volume-2/complying-with-gdpr-an-agile-case-study}}</ref>, including laboratory informatics applications. Developers of these applications, including enterprise laboratory informatics applications, must take into account<ref name="ShanlerHype23" /><ref name="ASTME1578" />:
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| * [[Database|shared database support]],
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| * [[Audit trail|shared audit trail implementation]],
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| * [[wikipedia:Authentication protocol|authentication protocol]]s,
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| * [[wikipedia:Configuration management|robust configuration management]],
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| * [[System integration|standardized integration methods]],
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| * [[Data model|standardized data models]],
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| * [[Data analysis|data analytics]],
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| * [[Backup|data backup]],
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| * [[data integrity]],
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| * [[Electronic signature|electronic signature implementation]],
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| * [[encryption]],
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| * [[information privacy]], and
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| * [[network security]].
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| These and other considerations are discussed in standards such as ASTM E1578-18<ref name="ASTME1578" /> and [[ISO/IEC 17025]].<ref name="ISO17025Peak">{{cite web |url=https://www.iso.org/obp/ui/#iso:std:iso-iec:17025:ed-3:v1:en |title=ISO/IEC 17025:2017(en) - General requirements for the competence of testing and calibration laboratories |work=ISO Online Browsing Platform (OBP) |publisher=International Organization for Standardization |date=2017 |accessdate=27 March 2024}}</ref>
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| ==Technology of laboratory informatics==
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| Important hardware and software systems that play a role in laboratory informatics include but are not limited to:
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| * [[Chromatography data system]]s (CDS)
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| * [[Electronic laboratory notebook]]s (ELN)
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| * [[Enterprise content management]] applications (ECM)
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| * [[Enterprise resource planning]] applications (ERP)
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| * [[Laboratory execution system]]s (LES)
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| * [[Laboratory information management system]]s (LIMS)
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| * [[Laboratory information system]]s (LIS)
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| * [[Manufacturing execution system]]s (MES)
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| * [[Scientific data management system]]s (SDMS)
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| ==See also==
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| For specialized applications of informatics to scientific disciplines, many of them involving laboratory work, see the [[informatics]] page.
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| ==References==
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| {{Reflist|colwidth=30em}}
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