Difference between revisions of "Laboratory execution system"
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A '''laboratory execution system''' or '''LES''' is a "computer system | [[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> | ||
==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> | |||
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== | ||
{{Reflist|colwidth=30em}} | |||
<!---Place all category tags here--> | <!---Place all category tags here--> | ||
[[Category:Laboratory informatics]] | [[Category:Laboratory informatics]] | ||
[[Category:Software systems]] | [[Category:Software systems]] | ||
Latest revision as of 16:24, 22 March 2024
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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
- ↑ 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.
- ↑ 2.0 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.
- ↑ 3.0 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
- ↑ 4.0 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.
- ↑ 5.0 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.
- ↑ "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.
- ↑ 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.
- ↑ 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.
- ↑ "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.
