Laboratory information management system - Revision history

Shawndouglas: Text replacement - "electronic health records" to "electronic health records"

2024-04-11T23:58:44Z

Text replacement - "electronic health records" to "electronic health records"

← Older revision		Revision as of 23:58, 11 April 2024
Line 43:		Line 43:

	====Electronic data exchange====		====Electronic data exchange====
	The exponentially growing volume of data created in laboratories, coupled with increased business demands and focuses on profitability, have pushed LIMS vendors to increase attention to how their LIMS handles the electronic exchange of data with other systems and instruments. The effectiveness of this data exchange is highly important to regulated industries that regularly report to an authority, as found with cannabis testing and some U.S. states' reporting requirements<ref name="AudinoManaging18" />, as well as clinical labs reporting to state- and federal-based public health agencies.<ref>{{Cite journal \|last=Rajamani \|first=Sripriya \|last2=Kayser \|first2=Ann \|last3=Emerson \|first3=Emily \|last4=Solarz \|first4=Sarah \|date=2018-09-21 \|title=Evaluation of Data Exchange Process for Interoperability and Impact on Electronic Laboratory Reporting Quality to a State Public Health Agency \|url=https://journals.uic.edu/ojs/index.php/ojphi/article/view/9317 \|journal=Online Journal of Public Health Informatics \|volume=10 \|issue=2 \|doi=10.5210/ojphi.v10i2.9317 \|issn=1947-2579 \|pmc=PMC6194099 \|pmid=30349622}}</ref> (Many labs' electronic systems' ability to exchange data with public health agencies was put to the test during the height of the [[COVID-19]] [[pandemic]].<ref name="DouglasWorkflow21">{{cite book \|url=https://www.limswiki.org/index.php/LII:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases) \|title=COVID-19 Testing, Reporting, and Information Management in the Laboratory \|chapter=4. Workflow and information management for COVID-19 (and other respiratory diseases) \|author=Douglas, S.E. \|publisher=LIMSwiki \|edition=Fall 2021 \|date=September 2021 \|accessdate=12 March 2024}}</ref> In some cases, academic clinical research labs with the means to test patients using their qPCR devices simply couldn't exchange data with health systems' [[electronic health records]] [EHRs], which ultimately excluded those labs from assisting with COVID-19 testing.<ref name="MaxmenThousands20">{{cite journal \|title=Thousands of coronavirus tests are going unused in US labs \|journal=Nature \|author=Maxmen, A. \|volume=580 \|issue=7803 \|pages=312–13 \|year=2020 \|doi=10.1038/d41586-020-01068-3 \|pmid=32273619}}</ref>)		The exponentially growing volume of data created in laboratories, coupled with increased business demands and focuses on profitability, have pushed LIMS vendors to increase attention to how their LIMS handles the electronic exchange of data with other systems and instruments. The effectiveness of this data exchange is highly important to regulated industries that regularly report to an authority, as found with cannabis testing and some U.S. states' reporting requirements<ref name="AudinoManaging18" />, as well as clinical labs reporting to state- and federal-based public health agencies.<ref>{{Cite journal \|last=Rajamani \|first=Sripriya \|last2=Kayser \|first2=Ann \|last3=Emerson \|first3=Emily \|last4=Solarz \|first4=Sarah \|date=2018-09-21 \|title=Evaluation of Data Exchange Process for Interoperability and Impact on Electronic Laboratory Reporting Quality to a State Public Health Agency \|url=https://journals.uic.edu/ojs/index.php/ojphi/article/view/9317 \|journal=Online Journal of Public Health Informatics \|volume=10 \|issue=2 \|doi=10.5210/ojphi.v10i2.9317 \|issn=1947-2579 \|pmc=PMC6194099 \|pmid=30349622}}</ref> (Many labs' electronic systems' ability to exchange data with public health agencies was put to the test during the height of the [[COVID-19]] [[pandemic]].<ref name="DouglasWorkflow21">{{cite book \|url=https://www.limswiki.org/index.php/LII:COVID-19_Testing,_Reporting,_and_Information_Management_in_the_Laboratory/Workflow_and_information_management_for_COVID-19_(and_other_respiratory_diseases) \|title=COVID-19 Testing, Reporting, and Information Management in the Laboratory \|chapter=4. Workflow and information management for COVID-19 (and other respiratory diseases) \|author=Douglas, S.E. \|publisher=LIMSwiki \|edition=Fall 2021 \|date=September 2021 \|accessdate=12 March 2024}}</ref> In some cases, academic clinical research labs with the means to test patients using their qPCR devices simply couldn't exchange data with health systems' [[Electronic health record\|electronic health records]] [EHRs], which ultimately excluded those labs from assisting with COVID-19 testing.<ref name="MaxmenThousands20">{{cite journal \|title=Thousands of coronavirus tests are going unused in US labs \|journal=Nature \|author=Maxmen, A. \|volume=580 \|issue=7803 \|pages=312–13 \|year=2020 \|doi=10.1038/d41586-020-01068-3 \|pmid=32273619}}</ref>)

	In particular, attention must be paid to how an instrument's input and output data is managed, how remote sample collection data is imported and exported, and how mobile and other third-party applications integrate with the LIMS. The successful transfer of data files in a wide variety of formats (including interoperable nonproprietary file types for better meeting the FAIR principles of making data and information more findable, accessible, interoperable, and reusable<ref name="BerezinTenSimp23" />), while maintaining the associated metadata and keeping it secure, is paramount. Historically speaking, the transition "from proprietary databases to standardized database management systems such as Oracle ... and SQL" has had significant impact on how data is managed and exchanged in laboratories<ref name="WoodCompLabInfo">{{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 \|page=1 \|date=September 2007 \|archivedate=25 August 2017 \|accessdate=12 March 2024}}</ref>, culminating today in cloud-based relational and NOSQL databases that can be set up, operated, and scaled with relative ease.<ref name="AWSAmazonRDS">{{cite web \|url=https://aws.amazon.com/rds/ \|title=Amazon Relational Database Service (RDS) \|publisher=Amazon Web Services, Inc \|accessdate=12 March 2024}}</ref><ref name="LardinoisGoogle17">{{cite web \|url=https://techcrunch.com/2017/02/14/google-launches-cloud-spanner-a-new-globally-distributed-database-service/ \|title=Google launches Cloud Spanner, its new globally distributed relational database service \|author=Lardionois, F. \|work=TechCrunch \|publisher=Oath, Inc \|date=14 February 2017 \|accessdate=12 March 2024}}</ref>		In particular, attention must be paid to how an instrument's input and output data is managed, how remote sample collection data is imported and exported, and how mobile and other third-party applications integrate with the LIMS. The successful transfer of data files in a wide variety of formats (including interoperable nonproprietary file types for better meeting the FAIR principles of making data and information more findable, accessible, interoperable, and reusable<ref name="BerezinTenSimp23" />), while maintaining the associated metadata and keeping it secure, is paramount. Historically speaking, the transition "from proprietary databases to standardized database management systems such as Oracle ... and SQL" has had significant impact on how data is managed and exchanged in laboratories<ref name="WoodCompLabInfo">{{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 \|page=1 \|date=September 2007 \|archivedate=25 August 2017 \|accessdate=12 March 2024}}</ref>, culminating today in cloud-based relational and NOSQL databases that can be set up, operated, and scaled with relative ease.<ref name="AWSAmazonRDS">{{cite web \|url=https://aws.amazon.com/rds/ \|title=Amazon Relational Database Service (RDS) \|publisher=Amazon Web Services, Inc \|accessdate=12 March 2024}}</ref><ref name="LardinoisGoogle17">{{cite web \|url=https://techcrunch.com/2017/02/14/google-launches-cloud-spanner-a-new-globally-distributed-database-service/ \|title=Google launches Cloud Spanner, its new globally distributed relational database service \|author=Lardionois, F. \|work=TechCrunch \|publisher=Oath, Inc \|date=14 February 2017 \|accessdate=12 March 2024}}</ref>

Shawndouglas: Text replacement - "Abbott Informatics Corporation" to "Abbott Informatics Corporation"

2024-04-04T22:15:11Z

Text replacement - "Abbott Informatics Corporation" to "Abbott Informatics Corporation"

← Older revision		Revision as of 22:15, 4 April 2024
Line 155:		Line 155:
	3. A LIMS is most competitive in group-centric settings (dealing with "batches" and "samples") that often deal with mostly anonymous research-specific laboratory data, whereas a LIS is usually most competitive in patient-centric settings (dealing with "subjects" and "specimens") and clinical labs.<ref name="analytica" /><ref name="lislims2">{{cite web \|url=http://labsoftnews.typepad.com/lab_soft_news/2008/11/lis-vs-lims.html \|title=LIS vs. LIMS: Some New Insights \|author=Friedman, B. \|work=Lab Soft News \|date=19 November 2008 \|accessdate=13 March 2024}}</ref><ref name="starlims">{{cite web \|url=http://blog.starlims.com/2009/07/01/swimming-in-the-clinical-pool-why-lims-are-supplanting-old-school-clinical-lis-applications/ \|archiveurl=https://web.archive.org/web/20110313145726/http://blog.starlims.com/2009/07/01/swimming-in-the-clinical-pool-why-lims-are-supplanting-old-school-clinical-lis-applications/ \|title=Swimming in the Clinical Pool: Why LIMS are supplanting old-school clinical LIS applications \|author=Hice, R. \|publisher=STARLIMS Corporation \|date=01 July 2009 \|archivedate=13 March 2011 \|accessdate=13 March 2024}}</ref>		3. A LIMS is most competitive in group-centric settings (dealing with "batches" and "samples") that often deal with mostly anonymous research-specific laboratory data, whereas a LIS is usually most competitive in patient-centric settings (dealing with "subjects" and "specimens") and clinical labs.<ref name="analytica" /><ref name="lislims2">{{cite web \|url=http://labsoftnews.typepad.com/lab_soft_news/2008/11/lis-vs-lims.html \|title=LIS vs. LIMS: Some New Insights \|author=Friedman, B. \|work=Lab Soft News \|date=19 November 2008 \|accessdate=13 March 2024}}</ref><ref name="starlims">{{cite web \|url=http://blog.starlims.com/2009/07/01/swimming-in-the-clinical-pool-why-lims-are-supplanting-old-school-clinical-lis-applications/ \|archiveurl=https://web.archive.org/web/20110313145726/http://blog.starlims.com/2009/07/01/swimming-in-the-clinical-pool-why-lims-are-supplanting-old-school-clinical-lis-applications/ \|title=Swimming in the Clinical Pool: Why LIMS are supplanting old-school clinical LIS applications \|author=Hice, R. \|publisher=STARLIMS Corporation \|date=01 July 2009 \|archivedate=13 March 2011 \|accessdate=13 March 2024}}</ref>

	However, these distinctions began to fade somewhat in the early 2010s as some LIMS vendors began to adopt the case-centric information management normally reserved for a LIS, blurring the lines between the two components further.<ref name="starlims" /> [[Vendor:Thermo Scientific\|Thermo Scientific]]'s Clinical LIMS was an example of this merger of LIMS with LIS, with Dave Champagne, informatics vice president and general manager, stating: "Routine molecular diagnostics requires a convergence of the up-to-now separate systems that have managed work in the lab (the LIMS) and the clinic (the LIS). The industry is asking for, and the science is requiring, a single lab-centric solution that delivers patient-centric results."<ref name="ConvergeLimsLis">{{cite web \|url=https://clpmag.com/lab-essentials/information-technology/convergence-of-lims-and-lis/ \|title=Convergence of LIMS and LIS \|author=Tufel, G. \|work=Clinical Lab Products \|publisher=MEDQOR \|date=01 February 2012 \|accessdate=13 March 2024}}</ref> [[Abbott Informatics Corporation]]'s STARLIMS product was another example of this LIMS/LIS merger.<ref name="StarlimsLimsLis" /> With the distinction between the two entities becoming less clear, discussions within the laboratory informatics community began to includes the question of whether or not the two entities should be considered the same.<ref name="LinkedInDifLisLims">{{cite web \|url=https://www.linkedin.com/feed/update/urn:li:groupPost:2069898-98494737/ \|title=What is the difference between a LIS and a LIMS? \|author=Jones, J. \|publisher=LinkedIn \|date=March 2012 \|accessdate=13 March 2024}}</ref><ref name="LinkedInLisLimsSame">{{cite web \|url=http://www.linkedin.com/groups/Are-LIMS-LIS-same-thing-2069898.S.147132083 \|title=Are LIMS and LIS the same thing? \|author=Jones, John \|publisher=LinkedIn \|date=September 2012 \|accessdate=07 November 2012}}{{Dead link}}</ref> {{As of\|2024}}, vendors continue to recognize the historical differences between the two products while also continuing to acknowledge that some developed LIMS are taking on more of the clinical aspects usually reserved for a LIS.<ref name="AgilabFAQ">{{cite web \|url=http://agilab.com/faq/ \|archiveurl=https://web.archive.org/web/20190325075813/http://agilab.com/faq/ \|title=FAQ: What is the difference between a LIMS and a medical laboratory quality system? \|publisher=AgiLab SAS \|archivedate=25 March 2019 \|accessdate=13 March 2024}}</ref><ref name="ReisenwitzWhatIs17">{{cite web \|url=https://www.capterra.com/resources/what-is-a-laboratory-information-management-system/ \|title=What Is a Laboratory Information Management System? \|author=Reisenwitz, C. \|work=Capterra Medical Software Blog \|publisher=Capterra, Inc \|date=11 May 2017 \|accessdate=13 March 2024}}</ref><ref name="CloudLISDifference16">{{cite web \|url=https://cloudlims.com/lims-vs-lis/ \|title=LIS vs LIMS: Uncover the Difference & Choose the Right Informatics Solution \|publisher=CloudLIMS.com, LLC \|date=12 October 2023 \|accessdate=13 March 2024}}</ref>		However, these distinctions began to fade somewhat in the early 2010s as some LIMS vendors began to adopt the case-centric information management normally reserved for a LIS, blurring the lines between the two components further.<ref name="starlims" /> [[Vendor:Thermo Scientific\|Thermo Scientific]]'s Clinical LIMS was an example of this merger of LIMS with LIS, with Dave Champagne, informatics vice president and general manager, stating: "Routine molecular diagnostics requires a convergence of the up-to-now separate systems that have managed work in the lab (the LIMS) and the clinic (the LIS). The industry is asking for, and the science is requiring, a single lab-centric solution that delivers patient-centric results."<ref name="ConvergeLimsLis">{{cite web \|url=https://clpmag.com/lab-essentials/information-technology/convergence-of-lims-and-lis/ \|title=Convergence of LIMS and LIS \|author=Tufel, G. \|work=Clinical Lab Products \|publisher=MEDQOR \|date=01 February 2012 \|accessdate=13 March 2024}}</ref> [[Vendor:Abbott Informatics Corporation\|Abbott Informatics Corporation]]'s STARLIMS product was another example of this LIMS/LIS merger.<ref name="StarlimsLimsLis" /> With the distinction between the two entities becoming less clear, discussions within the laboratory informatics community began to includes the question of whether or not the two entities should be considered the same.<ref name="LinkedInDifLisLims">{{cite web \|url=https://www.linkedin.com/feed/update/urn:li:groupPost:2069898-98494737/ \|title=What is the difference between a LIS and a LIMS? \|author=Jones, J. \|publisher=LinkedIn \|date=March 2012 \|accessdate=13 March 2024}}</ref><ref name="LinkedInLisLimsSame">{{cite web \|url=http://www.linkedin.com/groups/Are-LIMS-LIS-same-thing-2069898.S.147132083 \|title=Are LIMS and LIS the same thing? \|author=Jones, John \|publisher=LinkedIn \|date=September 2012 \|accessdate=07 November 2012}}{{Dead link}}</ref> {{As of\|2024}}, vendors continue to recognize the historical differences between the two products while also continuing to acknowledge that some developed LIMS are taking on more of the clinical aspects usually reserved for a LIS.<ref name="AgilabFAQ">{{cite web \|url=http://agilab.com/faq/ \|archiveurl=https://web.archive.org/web/20190325075813/http://agilab.com/faq/ \|title=FAQ: What is the difference between a LIMS and a medical laboratory quality system? \|publisher=AgiLab SAS \|archivedate=25 March 2019 \|accessdate=13 March 2024}}</ref><ref name="ReisenwitzWhatIs17">{{cite web \|url=https://www.capterra.com/resources/what-is-a-laboratory-information-management-system/ \|title=What Is a Laboratory Information Management System? \|author=Reisenwitz, C. \|work=Capterra Medical Software Blog \|publisher=Capterra, Inc \|date=11 May 2017 \|accessdate=13 March 2024}}</ref><ref name="CloudLISDifference16">{{cite web \|url=https://cloudlims.com/lims-vs-lis/ \|title=LIS vs LIMS: Uncover the Difference & Choose the Right Informatics Solution \|publisher=CloudLIMS.com, LLC \|date=12 October 2023 \|accessdate=13 March 2024}}</ref>

	==Regulations, standards, and best practices affecting LIMS development and use==		==Regulations, standards, and best practices affecting LIMS development and use==

Shawndouglas: Text replacement - "Thermo Scientific" to "Thermo Scientific"

2024-03-28T01:18:53Z

Text replacement - "Thermo Scientific" to "Thermo Scientific"

← Older revision		Revision as of 01:18, 28 March 2024
Line 155:		Line 155:
	3. A LIMS is most competitive in group-centric settings (dealing with "batches" and "samples") that often deal with mostly anonymous research-specific laboratory data, whereas a LIS is usually most competitive in patient-centric settings (dealing with "subjects" and "specimens") and clinical labs.<ref name="analytica" /><ref name="lislims2">{{cite web \|url=http://labsoftnews.typepad.com/lab_soft_news/2008/11/lis-vs-lims.html \|title=LIS vs. LIMS: Some New Insights \|author=Friedman, B. \|work=Lab Soft News \|date=19 November 2008 \|accessdate=13 March 2024}}</ref><ref name="starlims">{{cite web \|url=http://blog.starlims.com/2009/07/01/swimming-in-the-clinical-pool-why-lims-are-supplanting-old-school-clinical-lis-applications/ \|archiveurl=https://web.archive.org/web/20110313145726/http://blog.starlims.com/2009/07/01/swimming-in-the-clinical-pool-why-lims-are-supplanting-old-school-clinical-lis-applications/ \|title=Swimming in the Clinical Pool: Why LIMS are supplanting old-school clinical LIS applications \|author=Hice, R. \|publisher=STARLIMS Corporation \|date=01 July 2009 \|archivedate=13 March 2011 \|accessdate=13 March 2024}}</ref>		3. A LIMS is most competitive in group-centric settings (dealing with "batches" and "samples") that often deal with mostly anonymous research-specific laboratory data, whereas a LIS is usually most competitive in patient-centric settings (dealing with "subjects" and "specimens") and clinical labs.<ref name="analytica" /><ref name="lislims2">{{cite web \|url=http://labsoftnews.typepad.com/lab_soft_news/2008/11/lis-vs-lims.html \|title=LIS vs. LIMS: Some New Insights \|author=Friedman, B. \|work=Lab Soft News \|date=19 November 2008 \|accessdate=13 March 2024}}</ref><ref name="starlims">{{cite web \|url=http://blog.starlims.com/2009/07/01/swimming-in-the-clinical-pool-why-lims-are-supplanting-old-school-clinical-lis-applications/ \|archiveurl=https://web.archive.org/web/20110313145726/http://blog.starlims.com/2009/07/01/swimming-in-the-clinical-pool-why-lims-are-supplanting-old-school-clinical-lis-applications/ \|title=Swimming in the Clinical Pool: Why LIMS are supplanting old-school clinical LIS applications \|author=Hice, R. \|publisher=STARLIMS Corporation \|date=01 July 2009 \|archivedate=13 March 2011 \|accessdate=13 March 2024}}</ref>

	However, these distinctions began to fade somewhat in the early 2010s as some LIMS vendors began to adopt the case-centric information management normally reserved for a LIS, blurring the lines between the two components further.<ref name="starlims" /> [[Thermo Scientific]]'s Clinical LIMS was an example of this merger of LIMS with LIS, with Dave Champagne, informatics vice president and general manager, stating: "Routine molecular diagnostics requires a convergence of the up-to-now separate systems that have managed work in the lab (the LIMS) and the clinic (the LIS). The industry is asking for, and the science is requiring, a single lab-centric solution that delivers patient-centric results."<ref name="ConvergeLimsLis">{{cite web \|url=https://clpmag.com/lab-essentials/information-technology/convergence-of-lims-and-lis/ \|title=Convergence of LIMS and LIS \|author=Tufel, G. \|work=Clinical Lab Products \|publisher=MEDQOR \|date=01 February 2012 \|accessdate=13 March 2024}}</ref> [[Abbott Informatics Corporation]]'s STARLIMS product was another example of this LIMS/LIS merger.<ref name="StarlimsLimsLis" /> With the distinction between the two entities becoming less clear, discussions within the laboratory informatics community began to includes the question of whether or not the two entities should be considered the same.<ref name="LinkedInDifLisLims">{{cite web \|url=https://www.linkedin.com/feed/update/urn:li:groupPost:2069898-98494737/ \|title=What is the difference between a LIS and a LIMS? \|author=Jones, J. \|publisher=LinkedIn \|date=March 2012 \|accessdate=13 March 2024}}</ref><ref name="LinkedInLisLimsSame">{{cite web \|url=http://www.linkedin.com/groups/Are-LIMS-LIS-same-thing-2069898.S.147132083 \|title=Are LIMS and LIS the same thing? \|author=Jones, John \|publisher=LinkedIn \|date=September 2012 \|accessdate=07 November 2012}}{{Dead link}}</ref> {{As of\|2024}}, vendors continue to recognize the historical differences between the two products while also continuing to acknowledge that some developed LIMS are taking on more of the clinical aspects usually reserved for a LIS.<ref name="AgilabFAQ">{{cite web \|url=http://agilab.com/faq/ \|archiveurl=https://web.archive.org/web/20190325075813/http://agilab.com/faq/ \|title=FAQ: What is the difference between a LIMS and a medical laboratory quality system? \|publisher=AgiLab SAS \|archivedate=25 March 2019 \|accessdate=13 March 2024}}</ref><ref name="ReisenwitzWhatIs17">{{cite web \|url=https://www.capterra.com/resources/what-is-a-laboratory-information-management-system/ \|title=What Is a Laboratory Information Management System? \|author=Reisenwitz, C. \|work=Capterra Medical Software Blog \|publisher=Capterra, Inc \|date=11 May 2017 \|accessdate=13 March 2024}}</ref><ref name="CloudLISDifference16">{{cite web \|url=https://cloudlims.com/lims-vs-lis/ \|title=LIS vs LIMS: Uncover the Difference & Choose the Right Informatics Solution \|publisher=CloudLIMS.com, LLC \|date=12 October 2023 \|accessdate=13 March 2024}}</ref>		However, these distinctions began to fade somewhat in the early 2010s as some LIMS vendors began to adopt the case-centric information management normally reserved for a LIS, blurring the lines between the two components further.<ref name="starlims" /> [[Vendor:Thermo Scientific\|Thermo Scientific]]'s Clinical LIMS was an example of this merger of LIMS with LIS, with Dave Champagne, informatics vice president and general manager, stating: "Routine molecular diagnostics requires a convergence of the up-to-now separate systems that have managed work in the lab (the LIMS) and the clinic (the LIS). The industry is asking for, and the science is requiring, a single lab-centric solution that delivers patient-centric results."<ref name="ConvergeLimsLis">{{cite web \|url=https://clpmag.com/lab-essentials/information-technology/convergence-of-lims-and-lis/ \|title=Convergence of LIMS and LIS \|author=Tufel, G. \|work=Clinical Lab Products \|publisher=MEDQOR \|date=01 February 2012 \|accessdate=13 March 2024}}</ref> [[Abbott Informatics Corporation]]'s STARLIMS product was another example of this LIMS/LIS merger.<ref name="StarlimsLimsLis" /> With the distinction between the two entities becoming less clear, discussions within the laboratory informatics community began to includes the question of whether or not the two entities should be considered the same.<ref name="LinkedInDifLisLims">{{cite web \|url=https://www.linkedin.com/feed/update/urn:li:groupPost:2069898-98494737/ \|title=What is the difference between a LIS and a LIMS? \|author=Jones, J. \|publisher=LinkedIn \|date=March 2012 \|accessdate=13 March 2024}}</ref><ref name="LinkedInLisLimsSame">{{cite web \|url=http://www.linkedin.com/groups/Are-LIMS-LIS-same-thing-2069898.S.147132083 \|title=Are LIMS and LIS the same thing? \|author=Jones, John \|publisher=LinkedIn \|date=September 2012 \|accessdate=07 November 2012}}{{Dead link}}</ref> {{As of\|2024}}, vendors continue to recognize the historical differences between the two products while also continuing to acknowledge that some developed LIMS are taking on more of the clinical aspects usually reserved for a LIS.<ref name="AgilabFAQ">{{cite web \|url=http://agilab.com/faq/ \|archiveurl=https://web.archive.org/web/20190325075813/http://agilab.com/faq/ \|title=FAQ: What is the difference between a LIMS and a medical laboratory quality system? \|publisher=AgiLab SAS \|archivedate=25 March 2019 \|accessdate=13 March 2024}}</ref><ref name="ReisenwitzWhatIs17">{{cite web \|url=https://www.capterra.com/resources/what-is-a-laboratory-information-management-system/ \|title=What Is a Laboratory Information Management System? \|author=Reisenwitz, C. \|work=Capterra Medical Software Blog \|publisher=Capterra, Inc \|date=11 May 2017 \|accessdate=13 March 2024}}</ref><ref name="CloudLISDifference16">{{cite web \|url=https://cloudlims.com/lims-vs-lis/ \|title=LIS vs LIMS: Uncover the Difference & Choose the Right Informatics Solution \|publisher=CloudLIMS.com, LLC \|date=12 October 2023 \|accessdate=13 March 2024}}</ref>

	==Regulations, standards, and best practices affecting LIMS development and use==		==Regulations, standards, and best practices affecting LIMS development and use==

Shawndouglas: /* History */ Fix

2024-03-20T15:36:41Z

History: Fix

← Older revision		Revision as of 15:36, 20 March 2024
Line 9:		Line 9:
	Up until the late 1970s, management of laboratory samples and their associated analysis and reporting was a time-consuming manual processes often riddled with transcription errors. This gave some organizations impetus to streamline the collection of data and how it was reported. Custom in-house solutions were developed by a few individual laboratories, while some enterprising entities at the same time sought to develop a more commercial reporting solution in the form of special instrument-based systems.<ref name="LIMSHistory">{{cite journal \|title=A brief history of LIMS \|journal=Laboratory Automation and Information Management \|author=Gibbon, G.A. \|volume=32 \|issue=1 \|pages=1–5 \|year=1996 \|doi=10.1016/1381-141X(95)00024-K}}</ref>		Up until the late 1970s, management of laboratory samples and their associated analysis and reporting was a time-consuming manual processes often riddled with transcription errors. This gave some organizations impetus to streamline the collection of data and how it was reported. Custom in-house solutions were developed by a few individual laboratories, while some enterprising entities at the same time sought to develop a more commercial reporting solution in the form of special instrument-based systems.<ref name="LIMSHistory">{{cite journal \|title=A brief history of LIMS \|journal=Laboratory Automation and Information Management \|author=Gibbon, G.A. \|volume=32 \|issue=1 \|pages=1–5 \|year=1996 \|doi=10.1016/1381-141X(95)00024-K}}</ref>

	In 1982, the first generation of LIMS was introduced in the form of a single centralized minicomputer, which offered laboratories the first opportunity to utilize automated reporting tools. As the interest in these early LIMS grew, industry leaders like Gerst Gibbon of the Federal Energy Technology Centre in Pittsburgh began planting the seeds through LIMS-related conferences. By 1988, the second-generation commercial offerings were tapping into [[~~Relational database~~\|relational databases]] to expand LIMS into more application-specific territory, and international LIMS conferences were in full swing. As personal computers became more powerful and prominent, a third generation of LIMS emerged in the early 1990s. These new LIMS took advantage of the developing client/server architecture, allowing laboratories to implement better data processing and exchanges.<ref name="LIMSHistory" />		In 1982, the first generation of LIMS was introduced in the form of a single centralized minicomputer, which offered laboratories the first opportunity to utilize automated reporting tools. As the interest in these early LIMS grew, industry leaders like Gerst Gibbon of the Federal Energy Technology Centre in Pittsburgh began planting the seeds through LIMS-related conferences. By 1988, the second-generation commercial offerings were tapping into [[Database\|relational databases]] to expand LIMS into more application-specific territory, and international LIMS conferences were in full swing. As personal computers became more powerful and prominent, a third generation of LIMS emerged in the early 1990s. These new LIMS took advantage of the developing client/server architecture, allowing laboratories to implement better data processing and exchanges.<ref name="LIMSHistory" />

	By 1995, the client/server tools had developed to the point of allowing processing of data anywhere on the network. Web-enabled LIMS were introduced the following year, enabling researchers to extend operations outside the confines of the laboratory. From 1996 to 2002, additional functionality was included in LIMS, from wireless networking capabilities and georeferencing of samples, to the adoption of [[XML]] standards and the development of internet-based purchasing.<ref name="LIMSHistory" />		By 1995, the client/server tools had developed to the point of allowing processing of data anywhere on the network. Web-enabled LIMS were introduced the following year, enabling researchers to extend operations outside the confines of the laboratory. From 1996 to 2002, additional functionality was included in LIMS, from wireless networking capabilities and georeferencing of samples, to the adoption of [[XML]] standards and the development of internet-based purchasing.<ref name="LIMSHistory" />

Shawndouglas: /* Regulations, standards, and best practices affecting LIMS development and use */ Typo

2024-03-15T17:03:36Z

Regulations, standards, and best practices affecting LIMS development and use: Typo

← Older revision		Revision as of 17:03, 15 March 2024
Line 160:		Line 160:
	A LIMS' development and use is affected by regulations, standards, and best practices such as:		A LIMS' development and use is affected by regulations, standards, and best practices such as:

	*[[21 CFR Part 11]] ''Electronic records; Electronic signature'': Regulated clinical-focused industries, such as [[medical device]]s or pharmaceuticals, are expected to comply with U.S. [[Food and Drug Administration]] (FDA) regulations like 21 CFR Part 11, which address matters of software validation, data integrity, [[data retention]], audit trails, signed records, and secured access to data. These matters pertain to software systems like LIMS and ELN, as well as ~~otheremployed~~ in modern laboratories.<ref name="21CFR11">{{cite web \|url=https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=11&showFR=1 \|title=CFR - Code of Federal Regulations Title 21, Part 11 Electronic Records; Electronic Signatures \|publisher=U.S. Food and Drug Administration \|date=22 December 2023 \|accessdate=12 March 2024}}</ref><ref name="RDEditorsAQuick12">{{cite web \|url=https://www.rdworldonline.com/a-quick-guide-to-eln-regulatory-requirements/ \|title=A Quick Guide to ELN Regulatory Requirements \|author=R&D Editors \|work=R&D World \|date=10 May 2012 \|accessdate=12 March 2024}}</ref><ref name="LFWhite20">{{cite web \|url=https://labfolder.com/wp-content/uploads/2020/01/Labfolder-CFR21-Part11-Whitepaper.docx-2.pdf \|format=PDF \|title=Whitepaper: FDA's 21 CFR Part 11 \|publisher=Labforward GmbH \|date=January 2020 \|accessdate=12 March 2024}}</ref>		*[[21 CFR Part 11]] ''Electronic records; Electronic signature'': Regulated clinical-focused industries, such as [[medical device]]s or pharmaceuticals, are expected to comply with U.S. [[Food and Drug Administration]] (FDA) regulations like 21 CFR Part 11, which address matters of software validation, data integrity, [[data retention]], audit trails, signed records, and secured access to data. These matters pertain to software systems like LIMS and ELN, as well as other systems employed in modern laboratories.<ref name="21CFR11">{{cite web \|url=https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=11&showFR=1 \|title=CFR - Code of Federal Regulations Title 21, Part 11 Electronic Records; Electronic Signatures \|publisher=U.S. Food and Drug Administration \|date=22 December 2023 \|accessdate=12 March 2024}}</ref><ref name="RDEditorsAQuick12">{{cite web \|url=https://www.rdworldonline.com/a-quick-guide-to-eln-regulatory-requirements/ \|title=A Quick Guide to ELN Regulatory Requirements \|author=R&D Editors \|work=R&D World \|date=10 May 2012 \|accessdate=12 March 2024}}</ref><ref name="LFWhite20">{{cite web \|url=https://labfolder.com/wp-content/uploads/2020/01/Labfolder-CFR21-Part11-Whitepaper.docx-2.pdf \|format=PDF \|title=Whitepaper: FDA's 21 CFR Part 11 \|publisher=Labforward GmbH \|date=January 2020 \|accessdate=12 March 2024}}</ref>
	*[[ASTM E1578]] ''Standard Guide for Laboratory Informatics'': This standard is geared towards a variety of stakeholders having some sort of professional interest in laboratory informatics. It intends to educate on and recommend approaches to laboratory software development, acquisition, implementation, and maintenance, including as how they relate to LIMS.<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=13 March 2024}}</ref>		*[[ASTM E1578]] ''Standard Guide for Laboratory Informatics'': This standard is geared towards a variety of stakeholders having some sort of professional interest in laboratory informatics. It intends to educate on and recommend approaches to laboratory software development, acquisition, implementation, and maintenance, including as how they relate to LIMS.<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=13 March 2024}}</ref>
	*[[Good laboratory practice]] (GLP): GLP is a quality- and data-driven approach to ensuring the safety, consistency, high quality, and reliability of developed and produced goods. These best practices address a variety of aspects of non-clinical research and manufacturing laboratory workflows, from personnel and equipment to tests and reporting. Some LIMS are developed to help labs better enforce a GLP approach to its operations.<ref>{{Cite book \|date=2023 \|editor-last=Elzagheid \|editor-first=Mohamed \|title=Chemical technicians: good laboratory practice and laboratory information management systems \|series=De Gruyter Textbook \|edition=1st \|publisher=De Gruyter \|place=Boston \|isbn=978-3-11-119110-2}}</ref>		*[[Good laboratory practice]] (GLP): GLP is a quality- and data-driven approach to ensuring the safety, consistency, high quality, and reliability of developed and produced goods. These best practices address a variety of aspects of non-clinical research and manufacturing laboratory workflows, from personnel and equipment to tests and reporting. Some LIMS are developed to help labs better enforce a GLP approach to its operations.<ref>{{Cite book \|date=2023 \|editor-last=Elzagheid \|editor-first=Mohamed \|title=Chemical technicians: good laboratory practice and laboratory information management systems \|series=De Gruyter Textbook \|edition=1st \|publisher=De Gruyter \|place=Boston \|isbn=978-3-11-119110-2}}</ref>

Shawndouglas: /* Regulations, standards, and best practices affecting LIMS development and use */ Spacing

2024-03-15T17:00:54Z

Regulations, standards, and best practices affecting LIMS development and use: Spacing

← Older revision		Revision as of 17:00, 15 March 2024
Line 163:		Line 163:
	*[[ASTM E1578]] ''Standard Guide for Laboratory Informatics'': This standard is geared towards a variety of stakeholders having some sort of professional interest in laboratory informatics. It intends to educate on and recommend approaches to laboratory software development, acquisition, implementation, and maintenance, including as how they relate to LIMS.<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=13 March 2024}}</ref>		*[[ASTM E1578]] ''Standard Guide for Laboratory Informatics'': This standard is geared towards a variety of stakeholders having some sort of professional interest in laboratory informatics. It intends to educate on and recommend approaches to laboratory software development, acquisition, implementation, and maintenance, including as how they relate to LIMS.<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=13 March 2024}}</ref>
	*[[Good laboratory practice]] (GLP): GLP is a quality- and data-driven approach to ensuring the safety, consistency, high quality, and reliability of developed and produced goods. These best practices address a variety of aspects of non-clinical research and manufacturing laboratory workflows, from personnel and equipment to tests and reporting. Some LIMS are developed to help labs better enforce a GLP approach to its operations.<ref>{{Cite book \|date=2023 \|editor-last=Elzagheid \|editor-first=Mohamed \|title=Chemical technicians: good laboratory practice and laboratory information management systems \|series=De Gruyter Textbook \|edition=1st \|publisher=De Gruyter \|place=Boston \|isbn=978-3-11-119110-2}}</ref>		*[[Good laboratory practice]] (GLP): GLP is a quality- and data-driven approach to ensuring the safety, consistency, high quality, and reliability of developed and produced goods. These best practices address a variety of aspects of non-clinical research and manufacturing laboratory workflows, from personnel and equipment to tests and reporting. Some LIMS are developed to help labs better enforce a GLP approach to its operations.<ref>{{Cite book \|date=2023 \|editor-last=Elzagheid \|editor-first=Mohamed \|title=Chemical technicians: good laboratory practice and laboratory information management systems \|series=De Gruyter Textbook \|edition=1st \|publisher=De Gruyter \|place=Boston \|isbn=978-3-11-119110-2}}</ref>

	*[[ISO 15189]] ''Medical laboratories — Requirements for quality and competence'': This standard specifies quality management approaches to clinical laboratory settings. It pulls inspiration from ISO/IEC 17025 while acknowledging the unique characteristics and needs of the clinical lab. The standard's requirements on laboratory need for addressing cybersecurity, system validation, and more apply directly to LIMS development and implementation.<ref>{{Cite journal \|last=Ilinca \|first=Radu \|last2=Chiriac \|first2=Ionuț A. \|last3=Luțescu \|first3=Dan A. \|last4=Ganea \|first4=Ionela \|last5=Hristodorescu-Grigore \|first5=Smaranda \|last6=Dănciulescu-Miulescu \|first6=Rucsandra-Elena \|date=2023-04-01 \|title=Understanding the key differences between ISO 15189:2022 and ISO 15189:2012 for an improved medical laboratory quality of service \|url=https://www.sciendo.com/article/10.2478/rrlm-2023-0011 \|journal=Revista Romana de Medicina de Laborator \|language=en \|volume=31 \|issue=2 \|pages=77–82 \|doi=10.2478/rrlm-2023-0011 \|issn=2284-5623}}</ref>		*[[ISO 15189]] ''Medical laboratories — Requirements for quality and competence'': This standard specifies quality management approaches to clinical laboratory settings. It pulls inspiration from ISO/IEC 17025 while acknowledging the unique characteristics and needs of the clinical lab. The standard's requirements on laboratory need for addressing cybersecurity, system validation, and more apply directly to LIMS development and implementation.<ref>{{Cite journal \|last=Ilinca \|first=Radu \|last2=Chiriac \|first2=Ionuț A. \|last3=Luțescu \|first3=Dan A. \|last4=Ganea \|first4=Ionela \|last5=Hristodorescu-Grigore \|first5=Smaranda \|last6=Dănciulescu-Miulescu \|first6=Rucsandra-Elena \|date=2023-04-01 \|title=Understanding the key differences between ISO 15189:2022 and ISO 15189:2012 for an improved medical laboratory quality of service \|url=https://www.sciendo.com/article/10.2478/rrlm-2023-0011 \|journal=Revista Romana de Medicina de Laborator \|language=en \|volume=31 \|issue=2 \|pages=77–82 \|doi=10.2478/rrlm-2023-0011 \|issn=2284-5623}}</ref>

	*[[ISO/IEC 17025]] ''General requirements for the competence of testing and calibration laboratories'': This standard has evolved significantly over the years, today expressing how analytical and calibration labs should best handle quality management through its operations.<ref>{{Cite journal \|last=Miguel \|first=Anna \|last2=Moreira \|first2=Renata \|last3=Oliveira \|first3=André \|date=2021 \|title=ISO/IEC 17025: History and introduction of concepts \|url=http://quimicanova.sbq.org.br/audiencia_pdf.asp?aid2=9279&nomeArquivo=AG2020-0467.pdf \|journal=Química Nova \|doi=10.21577/0100-4042.20170726}}</ref> Like ISO 15189, this standard addresses many activities of these labs and how they should best performed to conform to a high level of quality. A LIMS has many ways to address the needs of a lab attempting to comply with the standard.<ref name="DouglasWhatKeyISO23" />		*[[ISO/IEC 17025]] ''General requirements for the competence of testing and calibration laboratories'': This standard has evolved significantly over the years, today expressing how analytical and calibration labs should best handle quality management through its operations.<ref>{{Cite journal \|last=Miguel \|first=Anna \|last2=Moreira \|first2=Renata \|last3=Oliveira \|first3=André \|date=2021 \|title=ISO/IEC 17025: History and introduction of concepts \|url=http://quimicanova.sbq.org.br/audiencia_pdf.asp?aid2=9279&nomeArquivo=AG2020-0467.pdf \|journal=Química Nova \|doi=10.21577/0100-4042.20170726}}</ref> Like ISO 15189, this standard addresses many activities of these labs and how they should best performed to conform to a high level of quality. A LIMS has many ways to address the needs of a lab attempting to comply with the standard.<ref name="DouglasWhatKeyISO23" />

Shawndouglas: Updated for 2024

2024-03-13T18:54:06Z

Updated for 2024

Show changes

Shawndouglas: Seed-to-sale

2023-12-27T22:54:46Z

Seed-to-sale

← Older revision		Revision as of 22:54, 27 December 2023
Line 41:		Line 41:
	In addition, a LIMS typically allows for the import and management of raw assay data results.<ref name="LBAssays">{{cite book \|title=Ligand-Binding Assays: Development, Validation, and Implementation in the Drug Development Arena \|author=Khan, Masood N.; Findlay, John W. \|chapter=11.6 Integration: Tying It All Together \|year=2009 \|pages=324 \|publisher=John Wiley & Sons \|url=https://books.google.com/books?id=QzM0LUMfdAkC \|isbn=0470041382 \|accessdate=21 March 2020}}</ref> Modern targeted assays such as qPCR and deep [[sequencing]] can produce tens of thousands of data points per sample. Furthermore, in the case of drug and diagnostic development, a dozen or more assays may be run for each sample. In order to track this data, a LIMS solution needs to be adaptable to many different assay formats at both the data layer and import creation layer, while maintaining a high level of overall performance.		In addition, a LIMS typically allows for the import and management of raw assay data results.<ref name="LBAssays">{{cite book \|title=Ligand-Binding Assays: Development, Validation, and Implementation in the Drug Development Arena \|author=Khan, Masood N.; Findlay, John W. \|chapter=11.6 Integration: Tying It All Together \|year=2009 \|pages=324 \|publisher=John Wiley & Sons \|url=https://books.google.com/books?id=QzM0LUMfdAkC \|isbn=0470041382 \|accessdate=21 March 2020}}</ref> Modern targeted assays such as qPCR and deep [[sequencing]] can produce tens of thousands of data points per sample. Furthermore, in the case of drug and diagnostic development, a dozen or more assays may be run for each sample. In order to track this data, a LIMS solution needs to be adaptable to many different assay formats at both the data layer and import creation layer, while maintaining a high level of overall performance.

	Increasingly, a LIMS also provides the ability to integrate with third-party applications such as [[enterprise resource planning]] systems or regulatory compliance systems (such as [[~~cannaqawiki:~~Seed-to-sale\|seed-to-sale]] reporting systems for [[wikipedia:Cannabis\|cannabis]] testing).<ref name="CSols10Ways17">{{cite web \|url=https://www.csolsinc.com/blog/10-ways-lims-can-automate-lab/ \|title=10 Ways LIMS Can Automate Your Lab \|publisher=CSols, Inc \|date=09 February 2017 \|accessdate=13 March 2020}}</ref><ref name="AudinoManaging18">{{cite web \|url=https://cannabisindustryjournal.com/feature_article/managing-cannabis-testing-lab-workflows-using-lims/ \|title=Managing Cannabis Testing Lab Workflows using LIMS \|author=Audino, S. \|work=Cannabis Industry Journal \|date=07 February 2018 \|accessdate=13 March 2019}}</ref> This integration is typically achieved through the use of an [[application programming interface]] (API)<ref name="CSols10Ways17" /><ref name="AudinoManaging18" />, code which serves as an interface between different software programs and facilitates their interaction.		Increasingly, a LIMS also provides the ability to integrate with third-party applications such as [[enterprise resource planning]] systems or regulatory compliance systems (such as [[Seed-to-sale\|seed-to-sale]] reporting systems for [[wikipedia:Cannabis\|cannabis]] testing).<ref name="CSols10Ways17">{{cite web \|url=https://www.csolsinc.com/blog/10-ways-lims-can-automate-lab/ \|title=10 Ways LIMS Can Automate Your Lab \|publisher=CSols, Inc \|date=09 February 2017 \|accessdate=13 March 2020}}</ref><ref name="AudinoManaging18">{{cite web \|url=https://cannabisindustryjournal.com/feature_article/managing-cannabis-testing-lab-workflows-using-lims/ \|title=Managing Cannabis Testing Lab Workflows using LIMS \|author=Audino, S. \|work=Cannabis Industry Journal \|date=07 February 2018 \|accessdate=13 March 2019}}</ref> This integration is typically achieved through the use of an [[application programming interface]] (API)<ref name="CSols10Ways17" /><ref name="AudinoManaging18" />, code which serves as an interface between different software programs and facilitates their interaction.

	====Electronic data exchange====		====Electronic data exchange====

Shawndouglas: Updated URLs for 2022

2022-01-06T22:13:03Z

Updated URLs for 2022

← Older revision		Revision as of 22:13, 6 January 2022
Line 47:		Line 47:

	====Additional functions====		====Additional functions====
	Aside from the key functions of sample management, instrument and application integration, and electronic data exchange, there are numerous additional operations that can be managed in a LIMS. This includes but is not limited to<ref name="ASTM_E1578">{{cite web \|url=https://www.astm.org/~~Standards/E1578~~.~~htm~~ \|title=ASTM E1578 - 18 Standard Guide for Laboratory Informatics \|publisher=ASTM International \|accessdate=~~21 March 2020~~}}</ref><ref name="TennenhouseHowOur16">{{cite web \|url=https://www.labmanager.com/surveys/how-our-readers-are-using-lims-4171 \|title=2016 LIMS User Survey Results \|author=Tennenhouse, E. \|work=Lab Manager \|publisher=LabX Media Group \|date=22 December 2016 \|accessdate=21 March 2020}}</ref><ref name="Barrington-LightDataInt17">{{cite web \|url=https://www.biosciencetechnology.com/article/2017/07/data-integrity-challenges-pharmaceutical-manufacturing-meeting-tomorrows-guidelines-today \|archiveurl=https://web.archive.org/web/20170914180035/https://www.biosciencetechnology.com/article/2017/07/data-integrity-challenges-pharmaceutical-manufacturing-meeting-tomorrows-guidelines-today \|title=Data Integrity Challenges in Pharmaceutical Manufacturing: Meeting Tomorrow’s Guidelines Today \|author=Barrington–Light, D. \|work=Bioscience Technology \|publisher=Advantage Business Media \|date=31 July 2017 \|archivedate=14 September 2017 \|accessdate=21 March 2020}}</ref>:		Aside from the key functions of sample management, instrument and application integration, and electronic data exchange, there are numerous additional operations that can be managed in a LIMS. This includes but is not limited to<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 \|accessdate=06 January 2022}}</ref><ref name="TennenhouseHowOur16">{{cite web \|url=https://www.labmanager.com/surveys/how-our-readers-are-using-lims-4171 \|title=2016 LIMS User Survey Results \|author=Tennenhouse, E. \|work=Lab Manager \|publisher=LabX Media Group \|date=22 December 2016 \|accessdate=21 March 2020}}</ref><ref name="Barrington-LightDataInt17">{{cite web \|url=https://www.biosciencetechnology.com/article/2017/07/data-integrity-challenges-pharmaceutical-manufacturing-meeting-tomorrows-guidelines-today \|archiveurl=https://web.archive.org/web/20170914180035/https://www.biosciencetechnology.com/article/2017/07/data-integrity-challenges-pharmaceutical-manufacturing-meeting-tomorrows-guidelines-today \|title=Data Integrity Challenges in Pharmaceutical Manufacturing: Meeting Tomorrow’s Guidelines Today \|author=Barrington–Light, D. \|work=Bioscience Technology \|publisher=Advantage Business Media \|date=31 July 2017 \|archivedate=14 September 2017 \|accessdate=21 March 2020}}</ref>:

	; [[Audit\|audit]] management		; [[Audit\|audit]] management
Line 109:		Line 109:
	=== LIMS configurability ===		=== LIMS configurability ===

	LIMS implementations are notorious for often being lengthy and costly.<ref name="SciCompRisksBens">{{cite web \|url=https://www.scientificcomputing.com/article/2010/03/industry-insights-examining-risks-benefits-and-trade-offs-today%E2%80%99s-lims \|title=Industry Insights: Examining the Risks, Benefits and Trade-offs of Today’s LIMS \|author=Royce, J.R. \|work=Scientific Computing \|publisher=Advantage Business Media \|date=31 March 2010 \|accessdate=14 September 2017}}</ref> This is due in part to the diversity of requirements within each lab, but also to the inflexible nature of LIMS products for adapting to these widely varying requirements. The technology of LIMS solutions has improved as software design methodologies have improved, however, and many more configurable and adaptable options exist than previously. This means not only that implementations are much faster, but also that the costs are lower and the risk of obsolescence is minimized.		LIMS implementations are notorious for often being lengthy and costly.<ref name="SciCompRisksBens">{{cite web \|url=https://www.scientificcomputing.com/article/2010/03/industry-insights-examining-risks-benefits-and-trade-offs-today%E2%80%99s-lims \|title=Industry Insights: Examining the Risks, Benefits and Trade-offs of Today’s LIMS \|author=Royce, J.R. \|work=Scientific Computing \|publisher=Advantage Business Media \|date=31 March 2010 \|accessdate=14 September 2017}}</ref>{{Dead link}} This is due in part to the diversity of requirements within each lab, but also to the inflexible nature of LIMS products for adapting to these widely varying requirements. The technology of LIMS solutions has improved as software design methodologies have improved, however, and many more configurable and adaptable options exist than previously. This means not only that implementations are much faster, but also that the costs are lower and the risk of obsolescence is minimized.

	==The distinction between a LIMS and a LIS==		==The distinction between a LIMS and a LIS==
	Historically, the LIMS and LIS have exhibited a few key differences, making them noticeably separate entities<ref name="StarlimsLimsLis">{{cite web \|url=http://www.starlims.com/en-us/services-and-resources/resources/lis-vs-lims/ \|archiveurl=https://web.archive.org/web/20140428060811/http://www.starlims.com/en-us/resources/white-papers/lis-vs-lims/ \|title=Adding "Management" to Your LIS \|publisher=STARLIMS Corporation \|date=2012 \|archivedate=28 April 2014 \|accessdate=14 September 2017}}</ref>:		Historically, the LIMS and LIS have exhibited a few key differences, making them noticeably separate entities<ref name="StarlimsLimsLis">{{cite web \|url=http://www.starlims.com/en-us/services-and-resources/resources/lis-vs-lims/ \|archiveurl=https://web.archive.org/web/20140428060811/http://www.starlims.com/en-us/resources/white-papers/lis-vs-lims/ \|title=Adding "Management" to Your LIS \|publisher=STARLIMS Corporation \|date=2012 \|archivedate=28 April 2014 \|accessdate=14 September 2017}}</ref>:

	1. A LIMS traditionally has been designed to process and report data related to batches of samples from biology labs, water treatment facilities, drug trials, and other entities that handle complex batches of data. A LIS has been designed primarily for processing and reporting data related to individual patients in a clinical setting.<ref name="lislims1">{{cite web \|url=http://labsoftnews.typepad.com/lab_soft_news/2008/11/liss-vs-limss-its-time-to-consider-merging-the-two-types-of-systems.html \|title=LIS vs. LIMS: It's Time to Blend the Two Types of Lab Information Systems \|author=Friedman, B. \|work=Lab Soft News \|date=04 November 2008 \|accessdate=07 November 2012}}</ref><ref name="analytica">{{cite web \|url=~~http~~://www.analytica-world.com/en/news/35566/lims-lis-market-and-poct-supplement.html \|title=LIMS/LIS Market and POCT Supplement \|work=analytica-world.com \|date=20 February 2004 \|accessdate=~~07 November 2012~~}}</ref>		1. A LIMS traditionally has been designed to process and report data related to batches of samples from biology labs, water treatment facilities, drug trials, and other entities that handle complex batches of data. A LIS has been designed primarily for processing and reporting data related to individual patients in a clinical setting.<ref name="lislims1">{{cite web \|url=http://labsoftnews.typepad.com/lab_soft_news/2008/11/liss-vs-limss-its-time-to-consider-merging-the-two-types-of-systems.html \|title=LIS vs. LIMS: It's Time to Blend the Two Types of Lab Information Systems \|author=Friedman, B. \|work=Lab Soft News \|date=04 November 2008 \|accessdate=07 November 2012}}</ref><ref name="analytica">{{cite web \|url=https://www.analytica-world.com/en/news/35566/lims-lis-market-and-poct-supplement.html \|title=LIMS/LIS Market and POCT Supplement \|work=analytica-world.com \|date=20 February 2004 \|accessdate=06 January 2022}}</ref>

	2. A LIMS needs to satisfy good manufacturing practice (GMP) and meet the reporting and audit needs of the U.S. [[Food and Drug Administration]] and research scientists in many different industries. A LIS, however, must satisfy the reporting and auditing needs of [[hospital]] accreditation agencies, [[HIPAA]], and other clinical medical practitioners.<ref name="lislims1" />		2. A LIMS needs to satisfy good manufacturing practice (GMP) and meet the reporting and audit needs of the U.S. [[Food and Drug Administration]] and research scientists in many different industries. A LIS, however, must satisfy the reporting and auditing needs of [[hospital]] accreditation agencies, [[HIPAA]], and other clinical medical practitioners.<ref name="lislims1" />
Line 120:		Line 120:
	3. A LIMS is most competitive in group-centric settings (dealing with "batches" and "samples") that often deal with mostly anonymous research-specific laboratory data, whereas a LIS is usually most competitive in patient-centric settings (dealing with "subjects" and "specimens") and clinical labs.<ref name="analytica" /><ref name="lislims2">{{cite web \|url=http://labsoftnews.typepad.com/lab_soft_news/2008/11/lis-vs-lims.html \|title=LIS vs. LIMS: Some New Insights \|author=Friedman, B. \|work=Lab Soft News \|date=19 November 2008 \|accessdate=07 November 2012}}</ref><ref name="starlims">{{cite web \|url=http://blog.starlims.com/2009/07/01/swimming-in-the-clinical-pool-why-lims-are-supplanting-old-school-clinical-lis-applications/ \|archiveurl=https://web.archive.org/web/20110313145726/http://blog.starlims.com/2009/07/01/swimming-in-the-clinical-pool-why-lims-are-supplanting-old-school-clinical-lis-applications/ \|title=Swimming in the Clinical Pool: Why LIMS are supplanting old-school clinical LIS applications \|author=Hice, R. \|publisher=STARLIMS Corporation \|date=01 July 2009 \|archivedate=13 March 2011 \|accessdate=14 September 2017}}</ref>		3. A LIMS is most competitive in group-centric settings (dealing with "batches" and "samples") that often deal with mostly anonymous research-specific laboratory data, whereas a LIS is usually most competitive in patient-centric settings (dealing with "subjects" and "specimens") and clinical labs.<ref name="analytica" /><ref name="lislims2">{{cite web \|url=http://labsoftnews.typepad.com/lab_soft_news/2008/11/lis-vs-lims.html \|title=LIS vs. LIMS: Some New Insights \|author=Friedman, B. \|work=Lab Soft News \|date=19 November 2008 \|accessdate=07 November 2012}}</ref><ref name="starlims">{{cite web \|url=http://blog.starlims.com/2009/07/01/swimming-in-the-clinical-pool-why-lims-are-supplanting-old-school-clinical-lis-applications/ \|archiveurl=https://web.archive.org/web/20110313145726/http://blog.starlims.com/2009/07/01/swimming-in-the-clinical-pool-why-lims-are-supplanting-old-school-clinical-lis-applications/ \|title=Swimming in the Clinical Pool: Why LIMS are supplanting old-school clinical LIS applications \|author=Hice, R. \|publisher=STARLIMS Corporation \|date=01 July 2009 \|archivedate=13 March 2011 \|accessdate=14 September 2017}}</ref>

	However, these distinctions began to fade somewhat in the early 2010s as some LIMS vendors began to adopt the case-centric information management normally reserved for a LIS, blurring the lines between the two components further.<ref name="starlims" /> [[Thermo Scientific]]'s Clinical LIMS was an example of this merger of LIMS with LIS, with Dave Champagne, informatics vice president and general manager, stating: "Routine molecular diagnostics requires a convergence of the up-to-now separate systems that have managed work in the lab (the LIMS) and the clinic (the LIS). The industry is asking for, and the science is requiring, a single lab-centric solution that delivers patient-centric results."<ref name="ConvergeLimsLis">{{cite web \|url=~~http~~://~~www.~~clpmag.com/~~2012~~/02/convergence-of-lims-and-lis/ \|title=Convergence of LIMS and LIS \|author=Tufel, G. \|work=Clinical Lab Products \|publisher=MEDQOR \|date=01 February 2012 \|accessdate=~~14 September 2017~~}}</ref> [[Abbott Informatics Corporation]]'s STARLIMS product was another example of this LIMS/LIS merger.<ref name="StarlimsLimsLis" /> With the distinction between the two entities becoming less clear, discussions within the laboratory informatics community began to includes the question of whether or not the two entities should be considered the same.<ref name="LinkedInDifLisLims">{{cite web \|url=https://www.linkedin.com/feed/update/urn:li:groupPost:2069898-98494737/ \|title=What is the difference between a LIS and a LIMS? \|author=Jones, J. \|publisher=LinkedIn \|date=March 2012 \|accessdate=14 September 2017}}</ref><ref name="LinkedInLisLimsSame">{{cite web \|url=http://www.linkedin.com/groups/Are-LIMS-LIS-same-thing-2069898.S.147132083 \|title=Are LIMS and LIS the same thing? \|author=Jones, John \|publisher=LinkedIn \|date=September 2012 \|accessdate=07 November 2012}}</ref> {{As of\|2017}}, vendors continue to recognize the historical differences between the two products while also continuing to acknowledge that some developed LIMS are taking on more of the clinical aspects usually reserved for a LIS.<ref name="AgilabFAQ">{{cite web \|url=http://agilab.com/faq/ \|archiveurl=https://web.archive.org/web/20190325075813/http://agilab.com/faq/ \|title=FAQ: What is the difference between a LIMS and a medical laboratory quality system? \|publisher=AgiLab SAS \|archivedate=25 March 2019 \|accessdate=21 March 2020}}</ref><ref name="CloudLISDifference16">{{cite web \|url=https://cloudlims.com/lims/lims-vs-lis.html \|title=Difference Between LIS and LIMS \|publisher=CloudLIMS.com, LLC \|date=01 October 2016 \|accessdate=14 September 2017}}</ref><ref name="ReisenwitzWhatIs17">{{cite web \|url=~~http~~://blog.capterra.com/what-is-a-laboratory-information-management-system/ \|title=What Is a Laboratory Information Management System? \|author=Reisenwitz, C. \|work=Capterra Medical Software Blog \|publisher=Capterra, Inc \|date=11 May 2017 \|accessdate=~~14 September 2017~~}}</ref>		However, these distinctions began to fade somewhat in the early 2010s as some LIMS vendors began to adopt the case-centric information management normally reserved for a LIS, blurring the lines between the two components further.<ref name="starlims" /> [[Thermo Scientific]]'s Clinical LIMS was an example of this merger of LIMS with LIS, with Dave Champagne, informatics vice president and general manager, stating: "Routine molecular diagnostics requires a convergence of the up-to-now separate systems that have managed work in the lab (the LIMS) and the clinic (the LIS). The industry is asking for, and the science is requiring, a single lab-centric solution that delivers patient-centric results."<ref name="ConvergeLimsLis">{{cite web \|url=https://clpmag.com/lab-essentials/information-technology/convergence-of-lims-and-lis/ \|title=Convergence of LIMS and LIS \|author=Tufel, G. \|work=Clinical Lab Products \|publisher=MEDQOR \|date=01 February 2012 \|accessdate=06 January 2022}}</ref> [[Abbott Informatics Corporation]]'s STARLIMS product was another example of this LIMS/LIS merger.<ref name="StarlimsLimsLis" /> With the distinction between the two entities becoming less clear, discussions within the laboratory informatics community began to includes the question of whether or not the two entities should be considered the same.<ref name="LinkedInDifLisLims">{{cite web \|url=https://www.linkedin.com/feed/update/urn:li:groupPost:2069898-98494737/ \|title=What is the difference between a LIS and a LIMS? \|author=Jones, J. \|publisher=LinkedIn \|date=March 2012 \|accessdate=14 September 2017}}</ref><ref name="LinkedInLisLimsSame">{{cite web \|url=http://www.linkedin.com/groups/Are-LIMS-LIS-same-thing-2069898.S.147132083 \|title=Are LIMS and LIS the same thing? \|author=Jones, John \|publisher=LinkedIn \|date=September 2012 \|accessdate=07 November 2012}}</ref> {{As of\|2017}}, vendors continue to recognize the historical differences between the two products while also continuing to acknowledge that some developed LIMS are taking on more of the clinical aspects usually reserved for a LIS.<ref name="AgilabFAQ">{{cite web \|url=http://agilab.com/faq/ \|archiveurl=https://web.archive.org/web/20190325075813/http://agilab.com/faq/ \|title=FAQ: What is the difference between a LIMS and a medical laboratory quality system? \|publisher=AgiLab SAS \|archivedate=25 March 2019 \|accessdate=21 March 2020}}</ref><ref name="CloudLISDifference16">{{cite web \|url=https://cloudlims.com/lims/lims-vs-lis.html \|title=Difference Between LIS and LIMS \|publisher=CloudLIMS.com, LLC \|date=01 October 2016 \|accessdate=14 September 2017}}</ref><ref name="ReisenwitzWhatIs17">{{cite web \|url=https://blog.capterra.com/what-is-a-laboratory-information-management-system/ \|title=What Is a Laboratory Information Management System? \|author=Reisenwitz, C. \|work=Capterra Medical Software Blog \|publisher=Capterra, Inc \|date=11 May 2017 \|accessdate=06 January 2022}}</ref>

	==Standards affecting LIMS==		==Standards affecting LIMS==
Line 139:		Line 139:

	==Further reading==		==Further reading==

	* {{cite journal \|title=A brief history of LIMS \|journal=Laboratory Automation and Information Management\|author=Gibbon, G.A. \|volume=32 \|issue=1 \|pages=1–5 \|year=1996 \|doi=10.1016/1381-141X(95)00024-K}}		* {{cite journal \|title=A brief history of LIMS \|journal=Laboratory Automation and Information Management\|author=Gibbon, G.A. \|volume=32 \|issue=1 \|pages=1–5 \|year=1996 \|doi=10.1016/1381-141X(95)00024-K}}

	* {{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 \|page=1 \|date=September 2007 \|archivedate=25 August 2017}}		* {{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 \|page=1 \|date=September 2007 \|archivedate=25 August 2017}}

	==References==		==References==
	{{Reflist\|colwidth=30em}}		{{Reflist\|colwidth=30em}}

Shawndouglas: More minor updates for 2020

2020-03-21T21:29:50Z

More minor updates for 2020

Show changes

← Older revision		Revision as of 17:00, 15 March 2024
Line 163:		Line 163:
	*[[ASTM E1578]] ''Standard Guide for Laboratory Informatics'': This standard is geared towards a variety of stakeholders having some sort of professional interest in laboratory informatics. It intends to educate on and recommend approaches to laboratory software development, acquisition, implementation, and maintenance, including as how they relate to LIMS.<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=13 March 2024}}</ref>		*[[ASTM E1578]] ''Standard Guide for Laboratory Informatics'': This standard is geared towards a variety of stakeholders having some sort of professional interest in laboratory informatics. It intends to educate on and recommend approaches to laboratory software development, acquisition, implementation, and maintenance, including as how they relate to LIMS.<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=13 March 2024}}</ref>
	*[[Good laboratory practice]] (GLP): GLP is a quality- and data-driven approach to ensuring the safety, consistency, high quality, and reliability of developed and produced goods. These best practices address a variety of aspects of non-clinical research and manufacturing laboratory workflows, from personnel and equipment to tests and reporting. Some LIMS are developed to help labs better enforce a GLP approach to its operations.<ref>{{Cite book \|date=2023 \|editor-last=Elzagheid \|editor-first=Mohamed \|title=Chemical technicians: good laboratory practice and laboratory information management systems \|series=De Gruyter Textbook \|edition=1st \|publisher=De Gruyter \|place=Boston \|isbn=978-3-11-119110-2}}</ref>		*[[Good laboratory practice]] (GLP): GLP is a quality- and data-driven approach to ensuring the safety, consistency, high quality, and reliability of developed and produced goods. These best practices address a variety of aspects of non-clinical research and manufacturing laboratory workflows, from personnel and equipment to tests and reporting. Some LIMS are developed to help labs better enforce a GLP approach to its operations.<ref>{{Cite book \|date=2023 \|editor-last=Elzagheid \|editor-first=Mohamed \|title=Chemical technicians: good laboratory practice and laboratory information management systems \|series=De Gruyter Textbook \|edition=1st \|publisher=De Gruyter \|place=Boston \|isbn=978-3-11-119110-2}}</ref>

	*[[ISO 15189]] ''Medical laboratories — Requirements for quality and competence'': This standard specifies quality management approaches to clinical laboratory settings. It pulls inspiration from ISO/IEC 17025 while acknowledging the unique characteristics and needs of the clinical lab. The standard's requirements on laboratory need for addressing cybersecurity, system validation, and more apply directly to LIMS development and implementation.<ref>{{Cite journal \|last=Ilinca \|first=Radu \|last2=Chiriac \|first2=Ionuț A. \|last3=Luțescu \|first3=Dan A. \|last4=Ganea \|first4=Ionela \|last5=Hristodorescu-Grigore \|first5=Smaranda \|last6=Dănciulescu-Miulescu \|first6=Rucsandra-Elena \|date=2023-04-01 \|title=Understanding the key differences between ISO 15189:2022 and ISO 15189:2012 for an improved medical laboratory quality of service \|url=https://www.sciendo.com/article/10.2478/rrlm-2023-0011 \|journal=Revista Romana de Medicina de Laborator \|language=en \|volume=31 \|issue=2 \|pages=77–82 \|doi=10.2478/rrlm-2023-0011 \|issn=2284-5623}}</ref>		*[[ISO 15189]] ''Medical laboratories — Requirements for quality and competence'': This standard specifies quality management approaches to clinical laboratory settings. It pulls inspiration from ISO/IEC 17025 while acknowledging the unique characteristics and needs of the clinical lab. The standard's requirements on laboratory need for addressing cybersecurity, system validation, and more apply directly to LIMS development and implementation.<ref>{{Cite journal \|last=Ilinca \|first=Radu \|last2=Chiriac \|first2=Ionuț A. \|last3=Luțescu \|first3=Dan A. \|last4=Ganea \|first4=Ionela \|last5=Hristodorescu-Grigore \|first5=Smaranda \|last6=Dănciulescu-Miulescu \|first6=Rucsandra-Elena \|date=2023-04-01 \|title=Understanding the key differences between ISO 15189:2022 and ISO 15189:2012 for an improved medical laboratory quality of service \|url=https://www.sciendo.com/article/10.2478/rrlm-2023-0011 \|journal=Revista Romana de Medicina de Laborator \|language=en \|volume=31 \|issue=2 \|pages=77–82 \|doi=10.2478/rrlm-2023-0011 \|issn=2284-5623}}</ref>

	*[[ISO/IEC 17025]] ''General requirements for the competence of testing and calibration laboratories'': This standard has evolved significantly over the years, today expressing how analytical and calibration labs should best handle quality management through its operations.<ref>{{Cite journal \|last=Miguel \|first=Anna \|last2=Moreira \|first2=Renata \|last3=Oliveira \|first3=André \|date=2021 \|title=ISO/IEC 17025: History and introduction of concepts \|url=http://quimicanova.sbq.org.br/audiencia_pdf.asp?aid2=9279&nomeArquivo=AG2020-0467.pdf \|journal=Química Nova \|doi=10.21577/0100-4042.20170726}}</ref> Like ISO 15189, this standard addresses many activities of these labs and how they should best performed to conform to a high level of quality. A LIMS has many ways to address the needs of a lab attempting to comply with the standard.<ref name="DouglasWhatKeyISO23" />		*[[ISO/IEC 17025]] ''General requirements for the competence of testing and calibration laboratories'': This standard has evolved significantly over the years, today expressing how analytical and calibration labs should best handle quality management through its operations.<ref>{{Cite journal \|last=Miguel \|first=Anna \|last2=Moreira \|first2=Renata \|last3=Oliveira \|first3=André \|date=2021 \|title=ISO/IEC 17025: History and introduction of concepts \|url=http://quimicanova.sbq.org.br/audiencia_pdf.asp?aid2=9279&nomeArquivo=AG2020-0467.pdf \|journal=Química Nova \|doi=10.21577/0100-4042.20170726}}</ref> Like ISO 15189, this standard addresses many activities of these labs and how they should best performed to conform to a high level of quality. A LIMS has many ways to address the needs of a lab attempting to comply with the standard.<ref name="DouglasWhatKeyISO23" />