Difference between revisions of "Laboratory informatics"

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[[Image:Pcr machine.jpg|thumb|right|An Eppendorf [[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 and managed to support future product development while maximizing [[laboratory]] operations.  
[[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/computing-and-automation/laboratory-informatics-20964 |title=Informatics Are Really, Really, Really Important |author=Metrick, G. |work=Lab Manager Magazine |date=21 July 2008 |accessdate=19 March 2020}}</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=25 August 2017}}</ref>


The field of laboratory informatics is a relatively new, rapidly developing field that 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>{{cite web_short|url=http://www.virtualinformatics.com/content/Laboratory_informatics.htm |title=Laboratory Informatics |publisher=virtualinformatics.com |date=09 April 2011 |accessdate=22 April 2011}}</ref> This has led to laboratories requiring more robust and scalable data management systems to stay competitive. The rapid rate of change in the technological and environmental needs of researchers — coupled with growing competition — has led to the creation of conferences like the [[IQPC]] [[Forum on Laboratory Informatics]] to help directors, managers, and researchers better keep up with the industry.<ref>{{cite web|url=http://www.labinformaticsforum.com/Event.aspx?id=428334 |title=IQPC 8th Forum on Laboratory Informatics |publisher=International Quality and Productivity Center |accessdate=2011-04-22}}</ref>
==History==


== Sub-topics in Laboratory Informatics ==
The term "laboratory [[Informatics (academic field)|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 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>


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>Wood, Simon (2007). [http://www.starlims.com/AL-Wood-Reprint-9-07.pdf "Comprehensive Laboratory Informatics: A Multilayer Approach"], pp. 2–3.</ref> A tiny but important cottage industry of businesses and consultants has developed from this philosophy, helping laboratories map their informatics needs to their corporate strategy.<ref>{{cite web_short|url=http://www.labvantage.com/services/services/labstrategy.aspx |title=Laboratory Informatics Strategy |publisher=labvantage.com |accessdate=22 April 2011}}</ref>
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=17 February 2017}}</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}}</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=19 March 2020}}</ref> Additionally, the rapid rate of change in the technological (e.g., cloud-computing, big data) and environmental needs (e.g., more automated workflows) 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/laboratory-technology/trends-in-laboratory-informatics-19119 |title=Trends in Laboratory Informatics |author=Metrick, G. |work=Lab Manager Magazine |date=08 December 2010 |accessdate=19 March 2020}}</ref>


{{As of|May 2019}}, market researchers such as Research and Markets have estimated the global market for laboratory informatics applications will reach $3.8 billion (U.S.) by 2024, up from roughly $2.6 billion in 2019. "The increasing need for laboratory automation; development of integrated lab informatics solutions; need to comply with regulatory requirements; and the growing demand in biobanks/biorepositories, academic research institutes, and CROs are the major factors driving the growth of the laboratory informatics market," says Research and Markets.<ref name="PRN3.8Bn19">{{cite web |url=https://www.prnewswire.com/news-releases/3-8-bn-laboratory-informatics-market---global-forecasts-to-2024-growing-demand-in-biobanksbiorepositories-academic-research-institutes-and-cros-300848731.html |title=$3.8 Bn Laboratory Informatics Market - Global Forecasts to 2024: Growing Demand in Biobanks/Biorepositories, Academic Research Institutes, and CROs |author=Research and Markets |work=PR Newswire |date=14 March 2019 |accessdate=19 March 2020}}</ref>


Important elements of laboratory informatics include but are not limited to:
==Sub-elements in laboratory informatics==


* [[Chromatography data management system]] (CDMS)
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 needs to their corporate strategy.<ref name=">{{cite web_short|url=http://www.labvantage.com/services/laboratory-strategy.aspx |title=Laboratory Informatics Strategy |publisher=labvantage.com |accessdate=01 January 2013}}</ref>
* [[Electronic laboratory notebook]] (ELN)
 
* [[Enterprise resource planning]] (ERP)
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.
* [[Laboratory information management system]] (LIMS)
 
* [[Manufacturing enterprise system]] (MES)
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-2018, the standard not only covers applications of informatics to general 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/Standards/E1578.htm |title=ASTM E1578 - 18: Standard Guide for Laboratory Informatics |publisher=ASTM International |accessdate=19 March 2020}}</ref><ref name="JonesASTME1578_18">{{cite web |url=https://cdn2.mindmeister.com/943721819/astm-e1578-scope-elements-of-laboratory-informatics?fullscreen=1 |title=ASTM 1578 (Scope & Elements of Laboratory Informatics) |author=Jones, J. |work=MindMeister |date=2018 |accessdate=19 March 2020}}</ref>
* [[Process analytical technology]] (PAT)
 
* [[Scientific data management system]] (SDMS)
===Additional considerations in laboratory informatics===
The actual processes 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 |title=An Explanation of Laboratory Governing Bodies, Regulations, and Applicable Laws |author=Poosa, S. |publisher=BC Solutions, LLC |date=November 2015 |accessdate=19 March 2020}}</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://pdfs.semanticscholar.org/033e/3f4cb88026804d1de861b6e1944d652cbd74.pdf |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 must take into account<ref name="ASTME1578" />:
 
* [[Audit trail|audit trail implementation]]
* [[wikipedia:Authentication protocol|authentication protocol]]s
* [[wikipedia:Configuration management|configuration management]]
* [[Backup|data backup]]
* [[data integrity]]
* [[Electronic signature|electronic signature implementation]]
* [[encryption]]
* [[information privacy]]
* [[network security]]
 
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=19 March 2020}}</ref>
 
==Technology of laboratory informatics==
 
Important hardware and software systems that play a role in laboratory informatics include but are not limited to:
 
* [[Chromatography data system]]s (CDS)
* [[Electronic laboratory notebook]]s (ELN)
* Enterprise content management applications (ECM)
* Enterprise resource planning applications (ERP)
* [[Laboratory execution system]]s (LES)
* [[Laboratory information management system]]s (LIMS)
* [[Laboratory information system]]s (LIS)
* Manufacturing enterprise systems (MES)
* Process analytical technology (PAT)
* [[Scientific data management system]]s (SDMS)


==References==
==References==
<references/>
{{Reflist|colwidth=30em}}
 
[[Category:Informatics]]
[[Category:Laboratory informatics]]

Revision as of 22:32, 19 March 2020

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.[1][2]

History

The term "laboratory informatics" has been in use at least since the early 1980s[3][4][5] 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 associated with that information management process.[6]

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."[7] 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.[8][9] Additionally, the rapid rate of change in the technological (e.g., cloud-computing, big data) and environmental needs (e.g., more automated workflows) 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.[10]

As of May 2019, market researchers such as Research and Markets have estimated the global market for laboratory informatics applications will reach $3.8 billion (U.S.) by 2024, up from roughly $2.6 billion in 2019. "The increasing need for laboratory automation; development of integrated lab informatics solutions; need to comply with regulatory requirements; and the growing demand in biobanks/biorepositories, academic research institutes, and CROs are the major factors driving the growth of the laboratory informatics market," says Research and Markets.[11]

Sub-elements in laboratory informatics

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.[2] A cottage industry of businesses and consultants has developed from this philosophy, helping laboratories map their informatics needs to their corporate strategy.[12]

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.

These sub-applications of laboratory informatics are also discussed in ASTM International's ASTM E1578-18 Standard Guide for Laboratory Informatics. Updated in mid-2018, the standard not only covers applications of informatics to general 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.[13][14]

Additional considerations in laboratory informatics

The actual processes 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.[15][16] This type of regulation has, of course, had an impact on the development of software in general[17][18], including laboratory informatics applications. Developers of these applications must take into account[13]:

These and other considerations are discussed in standards such as ASTM E1578-18[13] and ISO/IEC 17025.[19]

Technology of laboratory informatics

Important hardware and software systems that play a role in laboratory informatics include but are not limited to:

References

  1. Metrick, G. (21 July 2008). "Informatics Are Really, Really, Really Important". Lab Manager Magazine. https://www.labmanager.com/computing-and-automation/laboratory-informatics-20964. Retrieved 19 March 2020. 
  2. 2.0 2.1 Wood, S. (September 2007). "Comprehensive Laboratory Informatics: A Multilayer Approach" (PDF). American Laboratory. pp. 3. Archived from the original on 25 August 2017. https://web.archive.org/web/20170825181932/https://www.it.uu.se/edu/course/homepage/lims/vt12/ComprehensiveLaboratoryInformatics.pdf. Retrieved 25 August 2017. 
  3. "Section 36: Health Economics and Hospital Management". Excerpta Medica 19 (1): 72, 534. 1983. https://books.google.com/books?id=z4GaAAAAIAAJ&q=%22laboratory+informatics%22&dq=%22laboratory+informatics%22&hl=en. 
  4. "Research". New Scientist (New Science Publications) 109: 66. 1986. https://books.google.com/books?id=uyceAQAAMAAJ&q=%22laboratory+informatics%22&dq=%22laboratory+informatics%22&hl=en. 
  5. "Introduction". Informatics in Pathology (Grune & Stratton) 1 (1): 1. 1986. https://books.google.com/books?id=PbNYAAAAYAAJ&q=%22laboratory+informatics%22&dq=%22laboratory+informatics%22&hl=en. 
  6. Cowan, D., ed. (2002). Informatics for the Clinical Laboratory: A Practical Guide (1st ed.). Springer. pp. 9. ISBN 9780387244495. https://books.google.com/books?id=OKqGfr6xgFkC&pg=PA9. 
  7. "Laboratory Informatics". virtualinformatics.com. 9 April 2011. Archived from the original on 25 April 2015. http://web.archive.org/web/20150425070143/http://virtualinformatics.com/content/Laboratory_informatics.htm. Retrieved 17 February 2017. 
  8. Krasovec, E. (2009). "LIMS Get Agile" (PDF). International Clinical Trials Spring 2009: 32, 34. https://www.informatics.abbott/shared/lims-get-agile.pdf. 
  9. "Agile Development in Laboratory Informatics". CSols, Inc.. 5 December 2019. https://www.csolsinc.com/blog/agile-development-in-laboratory-informatics/. Retrieved 19 March 2020. 
  10. Metrick, G. (8 December 2010). "Trends in Laboratory Informatics". Lab Manager Magazine. https://www.labmanager.com/laboratory-technology/trends-in-laboratory-informatics-19119. Retrieved 19 March 2020. 
  11. Research and Markets (14 March 2019). "$3.8 Bn Laboratory Informatics Market - Global Forecasts to 2024: Growing Demand in Biobanks/Biorepositories, Academic Research Institutes, and CROs". PR Newswire. https://www.prnewswire.com/news-releases/3-8-bn-laboratory-informatics-market---global-forecasts-to-2024-growing-demand-in-biobanksbiorepositories-academic-research-institutes-and-cros-300848731.html. Retrieved 19 March 2020. 
  12. 13.0 13.1 13.2 "ASTM E1578 - 18: Standard Guide for Laboratory Informatics". ASTM International. https://www.astm.org/Standards/E1578.htm. Retrieved 19 March 2020. 
  13. Jones, J. (2018). "ASTM 1578 (Scope & Elements of Laboratory Informatics)". MindMeister. https://cdn2.mindmeister.com/943721819/astm-e1578-scope-elements-of-laboratory-informatics?fullscreen=1. Retrieved 19 March 2020. 
  14. Matsushita, H.; Miyachi, H. (2009). "Compliance with laboratory requirements regarding the secondary use of clinical specimens and laboratory data". Rinsho Byori 57 (7): 678–82. PMID 19708538. 
  15. Poosa, S. (November 2015). "An Explanation of Laboratory Governing Bodies, Regulations, and Applicable Laws". BC Solutions, LLC. http://www.bcsolutionsrfn.com/wp-content/uploads/2015/11/explanation-of-laboratory-governing-bodies-regulations-and-applicable-laws.pdf. Retrieved 19 March 2020. 
  16. Hamou-Lhadj, A. (2010). "Regulatory Compliance and its Impact on Software Development" (PDF). Proceedings from the First Workshop on Law Compliancy Issues in Organisational Systems and Strategies (iComply10): 1–5. https://pdfs.semanticscholar.org/033e/3f4cb88026804d1de861b6e1944d652cbd74.pdf. 
  17. Miri, M.; Foomany, F.H.; Mohammed, N. (2018). "Complying With GDPR: An Agile Case Study". ISACA Journal 2: 1–7. https://www.isaca.org/resources/isaca-journal/issues/2018/volume-2/complying-with-gdpr-an-agile-case-study. 
  18. "ISO/IEC 17025:2017(en) - General requirements for the competence of testing and calibration laboratories". ISO Online Browsing Platform (OBP). International Organization for Standardization. 2017. https://www.iso.org/obp/ui/#iso:std:iso-iec:17025:ed-3:v1:en. Retrieved 19 March 2020.