Difference between revisions of "Laboratory execution system"

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A '''laboratory execution system''' or '''LES''' is a "computer system employed in the [[laboratory]] at the analyst work level to aid in step enforcement for laboratory test method execution," according to the 2007 Annual Book of ASTM Standards.<ref name="LES_ASTM">{{cite book |url=https://books.google.com/books?id=znlGAAAAYAAJ&q=%22laboratory+execution+system%22&dq=%22laboratory+execution+system%22&hl=en&sa=X&ei=YKUiUbHrE4O9ywHH_YC4BA&ved=0CDYQ6AEwAA |title=Annual Book of ASTM Standards 2007 |author=American Society for Testing and Materials |year=2007 |publisher=ASTM |page=296 |isbn=0803142765}}</ref> The general purpose of the LES is to direct the user to follow specific steps to ensure the rigidity of the test method and and the process' end results, though alternate workflow routes may be applied in specific circumstances. The LES may encompass this functionality and more, including tasks like enforcing [[ELN feature#Document creation and management|standard operating procedures]] (SOPs), [[ELN feature#Data validation|validating]] calculations and instrument interfaces, and acquiring or importing procedural data from other systems into one common system.<ref name="SciCompQAQC">{{cite journal |url=https://www.thefreelibrary.com/QA%2FQC%3A+ELNs+have+come+a+long+way%3A+realizing+the+full+potential+of...-a0272245303 |journal=Scientific Computing |issue=1 |volume=28 |pages=19 |title=QA/QC: ELNs Have Come a Long Way |author=Metrick, G. |year=January 2011 |accessdate=21 March 2020}}</ref>
[[File:Generic Drug Research (5962) (8492611399).jpg|right|thumb|300px|A pharmaceutical quality control laboratory represents one example of a place where a laboratory execution system (LES) may be used.]]A '''laboratory execution system''' or '''LES''' is a "computer system used in the [[laboratory]] at the analyst work level to aid in step enforcement for laboratory test method execution," according to ASTM International.<ref name="LES_ASTM">{{cite book |url=https://books.google.com/books?id=znlGAAAAYAAJ&q=%22laboratory+execution+system%22&dq=%22laboratory+execution+system%22&hl=en&sa=X&ei=YKUiUbHrE4O9ywHH_YC4BA&ved=0CDYQ6AEwAA |title=Annual Book of ASTM Standards 2007 |author=American Society for Testing and Materials |year=2007 |publisher=ASTM |page=296 |isbn=0803142765}}</ref><ref name="ASTM_E1578">{{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 |page=4 |accessdate=21 March 2024}}</ref>  


For some, an LES may be considered a sub-branch of an [[electronic laboratory notebook]] (ELN) specifically made for laboratories engaging in quality control and quality assurance applications<ref name="SciCompQAQC" /><ref name="GITELNArt">{{cite journal |url=http://www.industriallabautomation.com/attachments/File/201111ELN-Mans-Many-Things-To-Many-People-GIT-Verlag-GLJ11-1211P.pdf |archiveurl=https://web.archive.org/web/20170328012245/http://www.industriallabautomation.com/attachments/File/201111ELN-Mans-Many-Things-To-Many-People-GIT-Verlag-GLJ11-1211P.pdf |journal=G.I.T. Laboratory Journal |issue=11-12 |volume=2011 |pages=14–16 |title=Electronic Laboratory Notebooks: ELN Means Many Things to Many People |author=Boogaard, Peter; Pijanowski, Patrick |year=Nov-Dec 2011 |archivedate=28 March 2017 |accessdate=21 March 2020}}</ref><ref name="LabAnswLES">{{cite web |url=http://labanswer.com/electronic-laboratory-notebooks-laboratory-execution-systems.asp |archiveurl=https://web.archive.org/web/20131012115959/http://labanswer.com/electronic-laboratory-notebooks-laboratory-execution-systems.asp |title=The Full Life-Cycle Development and Implementation of ELN/LES Systems |publisher=LabAnswer.com |archivedate=12 October 2013 |accessdate=21 March 2020}}</ref>, while others may consider it simply a separate set of functionality which may be found in an ELN or a [[laboratory information management system|LIMS]].<ref name="GITELNArt" /><ref name="LES_LIPost">{{cite web |url=https://www.limsforum.com/forum/is-a-lab-execution-system-just-another-name-for-a-lims/ |title=Is a Lab Execution System just another name for a LIMS? |author=Jones, J. |publisher=LIMSforum |date=January 2013 |accessdate=21 March 2020}}</ref> Some in the industry suggest the term "laboratory execution system" is a vendor-led morphing of the "method execution system," which was originally designed "to address the problem of standard operating procedure (SOP) compliance."<ref name="RoadmapClearELN">{{cite journal |url=http://www.scientificcomputing.com/article-in-Roadmap-to-a-Clear-Definition-of-ELN-051509.aspx |archiveurl=https://web.archive.org/web/20120814161250/http://www.scientificcomputing.com/article-in-Roadmap-to-a-Clear-Definition-of-ELN-051509.aspx |journal=Scientific Computing |issue=3 |volume=26 |pages=E11 |title=Roadmap to a Clear Definition of ELN |author=Hice, Randy C. |year=May 2009 |archivedate=14 August 2012 |accessdate=21 March 2020}}</ref>
==Purpose and use==
The general purpose of an LES is to direct the laboratory user to follow specific steps to ensure the rigidity of a test method or process' end results, though alternate workflow routes may be applied in specific circumstances. A lab technician would follow prompts from the system at every step of a method or process and sign off at each step through the LES.<ref name="KranjcIntro21">{{Citation |last=Kranjc |first=Tilen |date=2021-08-16 |editor-last=Zupancic |editor-first=Klemen |editor2-last=Pavlek |editor2-first=Tea |editor3-last=Erjavec |editor3-first=Jana |title=Introduction to Laboratory Software Solutions and Differences Between Them |url=https://onlinelibrary.wiley.com/doi/10.1002/9783527825042.ch3 |work=Digital Transformation of the Laboratory |language=en |edition=1 |publisher=Wiley |pages=75–84 |doi=10.1002/9783527825042.ch3 |isbn=978-3-527-34719-3}}</ref>  


In France, the English word "Middleware" is used to define a LES.
Historically, some have considered the LES a sub-branch of an [[electronic laboratory notebook]] (ELN) specifically made for laboratories engaging in quality control and quality assurance applications with rigid test methods<ref name="ASTM_E1578" /><ref name="SciCompQAQC">{{cite journal |url=https://www.thefreelibrary.com/QA%2FQC%3A+ELNs+have+come+a+long+way%3A+realizing+the+full+potential+of...-a0272245303 |archiveurl=https://web.archive.org/web/20210125174410/https://www.thefreelibrary.com/QA%2FQC%3A+ELNs+have+come+a+long+way%3A+realizing+the+full+potential+of...-a0272245303 |journal=Scientific Computing |issue=1 |volume=28 |pages=19 |title=QA/QC: ELNs Have Come a Long Way |author=Metrick, G. |year=2011 |archivedate=25 January 2021 |accessdate=21 March 2024}}</ref><ref name="GITELNArt">{{cite journal |url=http://www.industriallabautomation.com/attachments/File/201111ELN-Mans-Many-Things-To-Many-People-GIT-Verlag-GLJ11-1211P.pdf |archiveurl=https://web.archive.org/web/20170328012245/http://www.industriallabautomation.com/attachments/File/201111ELN-Mans-Many-Things-To-Many-People-GIT-Verlag-GLJ11-1211P.pdf |journal=G.I.T. Laboratory Journal |issue=11-12 |volume=2011 |pages=14–16 |title=Electronic Laboratory Notebooks: ELN Means Many Things to Many People |author=Boogaard, Peter; Pijanowski, Patrick |year=Nov-Dec 2011 |archivedate=28 March 2017 |accessdate=21 March 2024}}</ref><ref name="LabAnswLES">{{cite web |url=http://labanswer.com/electronic-laboratory-notebooks-laboratory-execution-systems.asp |archiveurl=https://web.archive.org/web/20131012115959/http://labanswer.com/electronic-laboratory-notebooks-laboratory-execution-systems.asp |title=The Full Life-Cycle Development and Implementation of ELN/LES Systems |publisher=LabAnswer.com |archivedate=12 October 2013 |accessdate=21 March 2024}}</ref>, while others may consider it simply a separate set of functionality which may be found in an ELN or a LIMS.<ref name="ASTM_E1578" /><ref name="GITELNArt" /><ref name="LES_LIPost">{{cite web |url=https://www.limsforum.com/forum/is-a-lab-execution-system-just-another-name-for-a-lims/ |title=Is a Lab Execution System just another name for a LIMS? |author=Jones, J. |publisher=LIMSforum |date=January 2013 |accessdate=21 March 2024}}</ref> Some in the industry suggest the term "laboratory execution system" is a vendor-led morphing of the "method execution system," which was originally designed "to address the problem of standard operating procedure (SOP) compliance."<ref name="RoadmapClearELN">{{cite journal |url=http://www.scientificcomputing.com/article-in-Roadmap-to-a-Clear-Definition-of-ELN-051509.aspx |archiveurl=https://web.archive.org/web/20120814161250/http://www.scientificcomputing.com/article-in-Roadmap-to-a-Clear-Definition-of-ELN-051509.aspx |journal=Scientific Computing |issue=3 |volume=26 |pages=E11 |title=Roadmap to a Clear Definition of ELN |author=Hice, Randy C. |year=May 2009 |archivedate=14 August 2012 |accessdate=21 March 2024}}</ref>
 
Aside from workflow step enforcement, a LES may have a variety of other functionality, including<ref name="KranjcIntro21" /><ref name="SciCompQAQC" /><ref name="CSolsThreeAreas17">{{cite web |url=https://www.csolsinc.com/blog/3-ways-a-laboratory-execution-system-saves-time-and-money/ |title=3 Areas a LES Can Drive Cost Savings |publisher=CSols, Inc |date=17 August 2017 |accessdate=21 March 2024}}</ref>:
 
* management of [[standard operating procedure]]s (SOPs);
* validation of inputs, calculations, expiration dates, instrument interfaces, etc.;
* acquisition or importing of procedural data from other systems into one common system;
* automation of calculations;
* verification of steps or results and sign-off using electronic signatures;
* support for audit trails with timestamps;
* management and alerting of non-conformances and out-of-specification results; and
* integration with third-party software, e.g., [[middleware]], statistical processing, data mining, and data visualization applications.


==References==
==References==
<references />
{{Reflist|colwidth=30em}}


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[[Category:Laboratory informatics]]
[[Category:Laboratory informatics]]
[[Category:Software systems]]
[[Category:Software systems]]

Latest revision as of 16:24, 22 March 2024

A pharmaceutical quality control laboratory represents one example of a place where a laboratory execution system (LES) may be used.

A laboratory execution system or LES is a "computer system used in the laboratory at the analyst work level to aid in step enforcement for laboratory test method execution," according to ASTM International.[1][2]

Purpose and use

The general purpose of an LES is to direct the laboratory user to follow specific steps to ensure the rigidity of a test method or process' end results, though alternate workflow routes may be applied in specific circumstances. A lab technician would follow prompts from the system at every step of a method or process and sign off at each step through the LES.[3]

Historically, some have considered the LES a sub-branch of an electronic laboratory notebook (ELN) specifically made for laboratories engaging in quality control and quality assurance applications with rigid test methods[2][4][5][6], while others may consider it simply a separate set of functionality which may be found in an ELN or a LIMS.[2][5][7] Some in the industry suggest the term "laboratory execution system" is a vendor-led morphing of the "method execution system," which was originally designed "to address the problem of standard operating procedure (SOP) compliance."[8]

Aside from workflow step enforcement, a LES may have a variety of other functionality, including[3][4][9]:

  • management of standard operating procedures (SOPs);
  • validation of inputs, calculations, expiration dates, instrument interfaces, etc.;
  • acquisition or importing of procedural data from other systems into one common system;
  • automation of calculations;
  • verification of steps or results and sign-off using electronic signatures;
  • support for audit trails with timestamps;
  • management and alerting of non-conformances and out-of-specification results; and
  • integration with third-party software, e.g., middleware, statistical processing, data mining, and data visualization applications.

References

  1. ↑ American Society for Testing and Materials (2007). Annual Book of ASTM Standards 2007. ASTM. p. 296. ISBN 0803142765. https://books.google.com/books?id=znlGAAAAYAAJ&q=%22laboratory+execution+system%22&dq=%22laboratory+execution+system%22&hl=en&sa=X&ei=YKUiUbHrE4O9ywHH_YC4BA&ved=0CDYQ6AEwAA. 
  2. ↑ 2.0 2.1 2.2 "ASTM E1578-18 Standard Guide for Laboratory Informatics". ASTM International. 23 August 2019. p. 4. https://www.astm.org/e1578-18.html. Retrieved 21 March 2024. 
  3. ↑ 3.0 3.1 Kranjc, Tilen (16 August 2021), Zupancic, Klemen; Pavlek, Tea; Erjavec, Jana, eds., "Introduction to Laboratory Software Solutions and Differences Between Them" (in en), Digital Transformation of the Laboratory (Wiley): 75–84, doi:10.1002/9783527825042.ch3, ISBN 978-3-527-34719-3, https://onlinelibrary.wiley.com/doi/10.1002/9783527825042.ch3 
  4. ↑ 4.0 4.1 Metrick, G. (2011). "QA/QC: ELNs Have Come a Long Way". Scientific Computing 28 (1): 19. Archived from the original on 25 January 2021. https://web.archive.org/web/20210125174410/https://www.thefreelibrary.com/QA%2FQC%3A+ELNs+have+come+a+long+way%3A+realizing+the+full+potential+of...-a0272245303. Retrieved 21 March 2024. 
  5. ↑ 5.0 5.1 Boogaard, Peter; Pijanowski, Patrick (Nov-Dec 2011). "Electronic Laboratory Notebooks: ELN Means Many Things to Many People". G.I.T. Laboratory Journal 2011 (11-12): 14–16. Archived from the original on 28 March 2017. https://web.archive.org/web/20170328012245/http://www.industriallabautomation.com/attachments/File/201111ELN-Mans-Many-Things-To-Many-People-GIT-Verlag-GLJ11-1211P.pdf. Retrieved 21 March 2024. 
  6. ↑ "The Full Life-Cycle Development and Implementation of ELN/LES Systems". LabAnswer.com. Archived from the original on 12 October 2013. https://web.archive.org/web/20131012115959/http://labanswer.com/electronic-laboratory-notebooks-laboratory-execution-systems.asp. Retrieved 21 March 2024. 
  7. ↑ Jones, J. (January 2013). "Is a Lab Execution System just another name for a LIMS?". LIMSforum. https://www.limsforum.com/forum/is-a-lab-execution-system-just-another-name-for-a-lims/. Retrieved 21 March 2024. 
  8. ↑ Hice, Randy C. (May 2009). "Roadmap to a Clear Definition of ELN". Scientific Computing 26 (3): E11. Archived from the original on 14 August 2012. https://web.archive.org/web/20120814161250/http://www.scientificcomputing.com/article-in-Roadmap-to-a-Clear-Definition-of-ELN-051509.aspx. Retrieved 21 March 2024. 
  9. ↑ "3 Areas a LES Can Drive Cost Savings". CSols, Inc. 17 August 2017. https://www.csolsinc.com/blog/3-ways-a-laboratory-execution-system-saves-time-and-money/. Retrieved 21 March 2024. 
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