Difference between revisions of "Electronic laboratory notebook"

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[[File:AGBell Notebook.jpg|right|thumb|Alexander Graham Bell's unpublished lab notebook, well before the invention of the ELN]]An '''electronic laboratory notebook''' (also known as electronic lab notebook or ELN) is a [[software]] program or package designed to replace more traditional paper [[laboratory notebook]]s. Laboratory notebooks in general are used by scientists and technicians to document, store, retrieve, and share fully electronic [[laboratory]] records in ways that meet all legal, regulatory, technical and scientific requirements. A laboratory notebook is often maintained to be a legal document and may be used in a court of law as evidence. Similar to an inventor's notebook, the lab notebook is also often referred to in patent prosecution and intellectual property litigation. Modern electronic lab notebooks have the advantage of being easier to search upon, support collaboration amongst many users, and can be made more secure than their paper counterparts.
{{About|the general software replacement for laboratory notebooks|other uses of the term "electronic laboratory notebook," "electronic lab notebook," or "ELN"|ELN}}<br />
[[File:AGBell Notebook.jpg|right|thumb|380px|Alexander Graham Bell's unpublished lab notebook, well before the invention of the ELN]]An '''electronic laboratory notebook''' (also known as '''electronic lab notebook''' or '''ELN''') is a [[software]] program or package designed to replace more traditional paper-based [[laboratory notebook]]s, which have for centuries been used by academic and industry researchers to document the procedures and results of experiments. ELNs in general are used by researchers to document, store, retrieve, and share fully electronic [[laboratory]] data and information—usually research-based—"in ways that meet all legal, regulatory, technical, and scientific requirements."<ref name="ZallTheNasc01">{{cite journal |title=The nascent paperless laboratory |journal=Chemical Innovation |author=Zall, M. |volume=31 |issue=2 |pages=14–21 |year=2001 |url=http://pubsapp.acs.org/subscribe/archive/ci/31/i02/html/02zall.html}}</ref> A well-designed ELN is also meant to act as legal documentation as well as scientific documentation, and it may be used in a court of law as evidence. Similar to an inventor's notebook, the lab notebook is also often referred to in patent prosecution and intellectual property litigation. Modern electronic lab notebooks have the advantage of being easier to search and share, better supporting collaboration among many users, and being more secure than their paper counterparts. However, the transition from paper-based laboratory notebooks to electronic versions can present a number of challenges to organizations, particularly in regards to researchers rejecting their use as being too time-consuming to learn, too difficult to use, and insufficient to meeting their needs.


==History of the ELN==
While some credit Dr. Keith Caserta with the concept of an electronic version of the laboratory notebook<ref name="EarlyELN">{{cite journal |title=Meeting Program Division of Chemical Education |journal=Chemical Information Bulletin |editor=Matthews, M. |volume=45 |issue=3 |page=64 |year=1993 |url=https://digital.library.unt.edu/ark:/67531/metadc5647/m1/48/}}</ref>, it's likely that others had similar early ideas on how to integrate computing into the process of laboratory note taking.<ref name="ELNLifeArch">{{cite web |url=http://web.me.com/evildrbob/Site/My_ELN_Life/My_ELN_Life.html |archiveurl=http://web.archive.org/web/20110515133816/http://web.me.com/evildrbob/Site/My_ELN_Life/My_ELN_Life.html |title=My ELN Life |author=Rumpf, W. |publisher=Wolfgang Rumpf, Ph.D |archivedate=15 May 2011 |accessdate=08 March 2024}}</ref> Significant discussion concerning the transition from a pen-and-paper laboratory notebook to an electronic format was already in full swing in the early 1990s. During the 206th National Meeting of the American Chemical Society in August of 1993, an entire day of the conference was dedicated to talking about "electronic notebooks" and ELNs.<ref name="MMattChemEd">{{cite journal |title=Meeting Program Division of Chemical Education |journal=Chemical Information Bulletin |editor=Matthews, M. |volume=45 |issue=3 |page=46 |year=1993 |url=https://digital.library.unt.edu/ark:/67531/metadc5647/m1/48/}}</ref> "A tetherless electronic equivalent of the paper notebook would be welcomed by the working scientist," noted Virginia Polytechnic Institute's Dr. Raymond E. Dessy for the conference.<ref name="EarlyELN" /> Dessy had in the mid-1980s begun postulating on the idea of an electronic notebook, and by 1994 he provided one of the first working examples of an ELN.<ref name="BormanELNRev">{{cite journal |url=https://pubs.acs.org/toc/cenear/72/21 |title=Electronic Laboratory Notebooks May Revolutionize Research Record Keeping |journal=Chemical Engineering News |author=Borman, S. |volume=72 |issue=21 |pages=10–20 |year=1994 |doi=10.1021/cen-v072n021.p010}}</ref>


==History of the ELN==
By 1997, a special interest group called the Collaborative Electronic Notebook Systems Association (CENSA) formed. Supported by 11 major pharmaceutical and chemical companies, the consortium worked with scientific software and hardware vendors to facilitate the creation of an ELN that met the technical and regulatory needs of its members.<ref name="LysakowskiTgeCikkav97">{{cite journal |title=The Collaborative Electronic Notebook Systems Consortium |journal=Proceedings of the 19th Annual International Conference of the IEEE Engineering in Medicine and Biology Society |author=Lysakowski, R. |volume=6 |pages=2659–2661 |year=1997 |doi=10.1109/IEMBS.1997.756879}}</ref> The consortium at that time envisioned a collaborative ELN that "teams of scientists worldwide can use to reliably capture, manage, securely share, and permanently archive and retrieve all common data and records generated by research and development and testing labs."<ref name="ChandlerDocument97">{{cite book |url=https://escholarship.org/uc/item/1m24k447#page-40 |title=Documenting the Biotechnology Industry in the San Francisco Bay Area |author=Chandler, R.L. |publisher=University of California - San Diego Libraries |page=40 |year=1997 |accessdate=21 March 2020}}</ref> That same year development of an enterprise-wide ELN at Kodak's research facilities in England was in full swing. The Kodak ELN was "implemented as a collection of Lotus Notes databases and applications," making it arguably one of the first enterprise ELN solutions in use at the time.<ref name="McLaughlinImpact99">{{cite book |chapter=Chapter 11: The Wired Laboratory |title=Impact of Advances in Computing and Communications Technologies on Chemical Science and Technology: Report of a Workshop |author=McLaughlin, D.R. |publisher=National Academy Press |year=1999 |pages=164 |isbn=0309065771 |url=https://www.nap.edu/read/9591/chapter/15#164}}</ref>
While some credit Dr. Keith Caserta with the concept of an electronic version of the laboratory notebook<ref name="EarlyELN">{{cite web|url=http://digital.library.unt.edu/ark:/67531/metadc5647/m1/48/ |title=Chemical Information Bulletin, Volume 45, Number 03, Summer 1993 |publisher=University of North Texas Digital Library |page=64 |date=1993 |accessdate=2011-05-03}}</ref>, it's likely that others had similar early ideas on how to integrate computing into the process of laboratory note taking.<ref>{{cite web|url=http://web.me.com/evildrbob/Site/My_ELN_Life/My_ELN_Life.html |title=My ELN Life|publisher=Wolfgang Rumpf, Ph.D |accessdate=2011-05-04}}</ref> Significant discussion concerning the transition from a pen-and-paper laboratory notebook to an electronic format was already in full swing in the early 1990s. During the 206th National Meeting of the American Chemical Society in August, 1993, an entire day of the conference was dedicated to talking about "electronic notebooks" and ELNs.<ref>{{cite web|url=http://digital.library.unt.edu/ark:/67531/metadc5647/m1/48/ |title=Chemical Information Bulletin, Volume 45, Number 03, Summer 1993 |publisher=University of North Texas Digital Library |page=46 |date=1993 |accessdate=2011-05-03}}</ref> "A tetherless electronic equivalent of the paper notebook would be welcomed by the working scientist," noted Virginia Polytechnic Institute's Dr. Raymond E. Dessy for the conference.<ref name="EarlyELN" /> Dessy had in the mid-1980s begun postulating on the idea of an electronic notebook, and by 1994 he provided one of the first working examples of an ELN.<ref>{{cite journal|journal=Chemical Engineering News|year=1994|volume=72|issue=21|pages=10–20|title=Electronic Laboratory Notebooks May Revolutionize Research Record Keeping |author=Borman, Stu|doi:10.1021/cen-v072n021.p010|url=http://pubs.acs.org/doi/abs/10.1021/cen-v072n021.p010|format=PDF}}</ref>


By 1997, a special interest group called the Collaborative Electronic Notebook Systems Association (CENSA) formed. Supported by 11 major pharmaceutical and chemical companies, the consortium worked with scientific software and hardware vendors to facilitate the creation of an ELN that met the technical and regulatory needs of its members.<ref>{{cite journal|journal=Proceedings of the 19th Annual International Conference of the IEEE Engineering in Medicine and Biology Society|year=1997|volume=6|pages=2659–2661|title=The Collaborative Electronic Notebook Systems Consortium |author=Lysakowski, R.|doi:10.1109/IEMBS.1997.756879 |url=http://ieeexplore.ieee.org/xpl/freeabs_all.jsp?arnumber=756879}}</ref> The consortium at that time envisioned a collaborative ELN that "teams of scientists worldwide can use to reliably capture, manage, securely share, and permanently archive and retrieve all common data and records generated by research and development and testing labs."<ref>{{cite web|url=http://escholarship.org/uc/item/1m24k447?query=electronic%20lab%20notebook;hitNum=1#page-40 |title=Documenting the Biotechnology Industry in the San Francisco Bay Area |publisher=University of California - San Diego Libraries |page=40 |date=1997 |accessdate=2011-05-03}}</ref>
In 1998 one of the first web-based versions of an ELN was introduced in the form of the University of Oregon's Virtual Notebook Environment (ViNE), "a platform-independent, web-based interface designed to support a range of scientific activities across distributed, heterogeneous computing platforms."<ref name="SkidmoreAProto98">{{cite journal |title=A Prototype Notebook-Based Environment for Computational Tools Computational Tools |journal=Proceedings of the 1998 ACM/IEEE conference on Supercomputing |author=Skidmore, J.L.; Sottile, M.J.; Cuny, J.E.; Malony, A.D. |year=1998 |pages=22 |doi=10.1109/SC.1998.10031}}</ref> This innovation would go on to inspire vendors in the 2000s to develop web-based thin-client ELNs for laboratories everywhere. Yet it likely wasn't until the [[Electronic Signatures in Global and National Commerce Act]] (ESIGN) in June 2000 that the true legal implications of what a fully electronic laboratory notebook would have on the industry. If an ELN were to be responsible for providing validation during the patent processes and be valid for other types of [[audit]]s, a mechanism for authenticating the origin of the ideas would be necessary. The ESIGN act meant that electronic records could be authenticated and [[Electronic signature|digital signatures]] made legally binding, lending further relevancy to ELNs. Instead of searching through notebooks and piles of documents, printing material, and submitting thousands of pages for an FDA audit, ELN users could suddenly collate and submit electronic records, saving time and headaches.<ref name="ZallTheNasc01" />


In 1998 one of the first web-based versions of an ELN was introduced in the form of the University of Oregon's Virtual Notebook Environment (ViNE), "a platform-independent, web-based interface designed to support a range of scientific activities across distributed, heterogeneous computing platforms."<ref>{{cite journal|journal=Proceedings of the 1998 ACM/IEEE conference on Supercomputing|year=1998|pages=22|title=A Prototype Notebook-Based Environment for Computational Tools Computational Tools |author=Skidmore, Jenifer L.; Matthew J. Sottile; Janice E. Cuny; Allen D. Malony|doi:10.1109/SC.1998.10031|url=http://www.computer.org/portal/web/csdl/doi/10.1109/SC.1998.10031|format=PDF}}</ref> This innovation would go on to inspire vendors in the 2000s to develop web-based thin-client ELNs for laboratories everywhere. Yet it likely wasn't until the [[Electronic Signatures in Global and National Commerce Act]] (ESIGN) in June 2000 that the true legal implications of a fully electronic laboratory notebook would have on the industry. If an ELN were to be responsible for providing validation during the patent processes and be valid for other types of [[audit]]s, a mechanism for authenticating the origin of the ideas would be necessary. The ESIGN act meant that electronic records could be authenticated and digital signatures made legally binding, lending further relevancy to ELNs. Instead of searching through notebooks and piles of documents, printing material, and submitting thousands of pages for an FDA audit, ELN users could suddenly collate and submit electronic records, saving time and headaches.<ref>{{cite journal|journal=Chemical Innovation|year=2001|pages=14–21|title=The nascent paperless laboratory |author=Zall, Milton|url=http://pubs.acs.org/subscribe/archive/ci/31/i02/html/02zall.html}}</ref>
Enthusiasm for ELNs began to pick up again in the early 2000s, with a strong case for further data integration into ELNs being made at the CENSA-supported International Quality & Productivity Center (IQPC) conference in London during September 2004. During that conference the push for stronger [[data integration]] was made, with the base premise that "ELNs would improve corporate strategy by allowing information to be used more intelligently with the help of decision-support software."<ref name="ReesHowTo04">{{cite web |url=https://www.scientific-computing.com/feature/how-capture-data-share |title=How to capture data to share |author=Rees, P. |work=Scientific Computing World |publisher=Europa Science |date=01 November 2004 |accessdate=08 March 2024}}</ref> By early 2007, industry-specific ELNs were pushing growth in the market: ''Scientific Computing World'' estimated 83 percent of related organizations declaring interest in ELNs, with 43 percent of those organizations seriously considering an evaluation or purchase.<ref name="SciCompWorld1">{{cite web |url=https://www.scientific-computing.com/feature/state-eln-market |author=Elliot, M.H. |title=The state of the ELN Market |work=Scientific Computing World |publisher=Europa Science |date=01 December 2006 |accessdate=08 March 2024}}</ref>


Enthusiasm for ELNs began to pick up again in the early 2000s, with a strong case for further data integration into ELNs being made at the CENSA-sponsored International Quality & Productivity Center (IQPC) conference in London during September 2004. During that conference the push for stronger data integration was made, with the base premise that "ELNs would improve corporate strategy by allowing information to be used more intelligently with the help of decision-support software."<ref>{{cite web|url=http://www.scientific-computing.com/features/feature.php?feature_id=63 |title=How to capture data to share |publisher=Scientific Computing World |date=November/December 2004 |accessdate=2011-05-04}}</ref> By early 2007, industry-specific ELNs were pushing growth in the market: Scientific Computing World estimated 83 percent of related organizations declaring interest in ELNs, with 43 percent of those organizations seriously considering an evaluation or purchase.<ref name="SciCompWorld1">{{cite web|url=http://www.scientific-computing.com/features/feature.php?feature_id=50 |title=The state of the ELN Market |publisher=Scientific Computing World |date=December 2006/January 2007 |accessdate=2011-05-04}}</ref>
Despite the beginnings of an economic downturn in the late 2000s, Atrium Research later estimated that the ELN's market potential was around $1.7 billion.<ref>{{cite web |url=http://www.atriumresearch.com/html/PR/pr060109.htm |title=Atrium Research Announces Fourth Edition of Landmark Report on Electronic Laboratory Notebooks |publisher=Atrium Research |date=02 June 2009 |accessdate=04 May 2011}}{{Dead link|date=March 2024}}</ref><ref name="LFinderAtrium07">{{cite web |url=http://www.limsfinder.com/BlogDetail.aspx?id=32062_0_3_0_C |archiveurl=https://web.archive.org/web/20070908031324/http://www.limsfinder.com/BlogDetail.aspx?id=32062_0_3_0_C |title=Atrium Research Announces the Third Edition of Landmark Report on Electronic Laboratory Notebooks |work=LIMSfinder.org |date=07 May 2007 |archivedate=08 September 2007 |accessdate=21 March 2020}}</ref> During this time, scientists and academics—traditionally slow to adopt technological change—were gradually warming up to the benefits of an ELN. Academics in particular realized the problems the high turnover postdoc rate created in research laboratories. Postdocs would depart from the university, leaving [[PI]]s and directors scratching their heads on where the data ended up. ELNs changed that, allowing much more persistent data that can be found and referenced even after a postdoc departs.<ref name="DanceDigital10">{{cite journal |title=Digital Upgrade: How to choose your lab's next electronic lab notebook |journal=The Scientist |author=Dance, A. |volume=24 |issue=5 |pages=71 |year=2010 |url=https://www.the-scientist.com/digital-upgrade-43342}}</ref>


Despite the beginnings of an economic downturn in the late 2000s, Atrium Research later estimated that ELN's market potential was around $1.7 billion.<ref>{{cite web|url=http://www.atriumresearch.com/html/PR/pr060109.htm |title=Atrium Research Announces Fourth Edition of Landmark Report on Electronic Laboratory Notebooks |publisher=Atrium Research |date=2009-06-02 |accessdate=2011-05-04}}</ref> During this time scientists and academics — traditionally slow to adopt technological change — were gradually warming up to the benefits of an electronic laboratory notebook. Academics in particular realized the problems the high turnover postdoc rate created in research laboratories. Postodocs would depart from the university, leaving [[PI]]s and directors scratching their heads on where the data ended up. ELNs changed that, allowing much more persistent data that can be found and referenced even after a postdoc departs.<ref>{{cite journal|journal=The Scientist|year=2010|volume=24|issue=5|pages=71|title=Digital Upgrade: How to choose your lab's next electronic lab notebook |author=Dance, Amber|url=http://www.the-scientist.com/article/display/57363/}}</ref> 
The movement towards ELN integration into other laboratory functions during the 2000s eventually led to the blurring of what an ELN actually is. In early 2007, ''Scientific Computing World'' reported that the definition of an ELN varied among scientists, with 35 percent of them stating they were "clear about the difference between a &#91;[[laboratory information management system]] (LIMS)&#93; and an ELN."<ref name="SciCompWorld1" /> Today, it's possible to see in some vendors' offerings the formerly distinct entity that was an ELN to now be completely integrated into a LIMS. {{As of|2024}}, ELNs can be found as standalone solutions or as integrated modules of some other software like a LIMS, running as locally installed software or in the [[Cloud computing|cloud]] under the [[software as a service]] model.  


The movement towards ELN integration into other laboratory functions during the 2000s eventually led to the blurring of what an ELN actually is. In early 2007 Scientific Computing World reported that the definition of an ELN varied among scientists, with 35 percent of them stating they were "clear about the difference between a [[LIMS]] and an ELN."<ref name="SciCompWorld1" /> Today it's possible to see in some vendors' offerings the formerly distinct entity that was ELN to now be completely integrated into a LIMS.
As modern laboratory research has increasingly incorporated more digital sources of data and information from instruments and other sources, labs conducting laboratory notebook-assisted research today—in both academic and industrial environments—have had to necessarily look at old paper notebook formats as antiquated and incompatible with modern research methods and increasingly digitalized workflows.<ref name="NussbeckTheLab14">{{cite journal |last=Nussbeck |first=Sara Y |last2=Weil |first2=Philipp |last3=Menzel |first3=Julia |last4=Marzec |first4=Bartlomiej |last5=Lorberg |first5=Kai |last6=Schwappach |first6=Blanche |year=2014 |title=The laboratory notebook in the 21 st century: The electronic laboratory notebook would enhance good scientific practice and increase research productivity |url=https://www.embopress.org/doi/10.15252/embr.201338358 |journal=EMBO reports |language=en |volume=15 |issue=6 |pages=631–634 |doi=10.15252/embr.201338358 |issn=1469-221X |pmc=PMC4197872 |pmid=24833749}}</ref><ref name="DirnaglAPocket16">{{cite journal |last=Dirnagl |first=Ulrich |last2=Przesdzing |first2=Ingo |date=2016-01-04 |title=A pocket guide to electronic laboratory notebooks in the academic life sciences |url=https://f1000research.com/articles/5-2/v1 |journal=F1000Research |language=en |volume=5 |pages=2 |doi=10.12688/f1000research.7628.1 |issn=2046-1402 |pmc=PMC4722687 |pmid=26835004}}</ref> With this greater need for an ELN, the ELN market was predicted in 2022 by Verified Market Research to reach nearly $795 million by 2028, below Atrium's late 2000s predictions but gaining ground again, with "the increasing need for data stored electronically ... imposing an assertive impact factor on the market."<ref name="VMSGlobal22">{{cite web |url=https://www.verifiedmarketresearch.com/product/electronic-lab-notebook-eln-market/ |title=Electronic Lab Notebook (ELN) Market Size And Forecast |publisher=Verified Market Research |date=May 2022 |accessdate=08 March 2024}}</ref> However, as ELNs have become more complex, often taking on additional functionality found in other laboratory systems like the LIMS, there has come with it a greater chance of overall cost and complexity of use increasing, in turn negatively impacting overall adoption of the ELN by laboratorians.<ref name="DirnaglAPocket16" /> As such, complex modern ELNs have needed to be more intuitive, easy-to-learn, and well-documented in order to better ensure full adoption.<ref name="HigginsConsider22">{{Cite journal |last=Higgins |first=Stuart G. |last2=Nogiwa-Valdez |first2=Akemi A. |last3=Stevens |first3=Molly M. |date=2022-02 |title=Considerations for implementing electronic laboratory notebooks in an academic research environment |url=https://www.nature.com/articles/s41596-021-00645-8 |journal=Nature Protocols |language=en |volume=17 |issue=2 |pages=179–189 |doi=10.1038/s41596-021-00645-8 |issn=1754-2189}}</ref>


==Regulations and legal aspects==
==Use of an ELN==
The laboratory accreditation criteria found in the [[ISO 17025]] standard needs to be considered for the protection and computer backup of electronic records. These criteria can be found specifically in clause 4.13.1.4 of the standard.  
An ELN is a modern electronic equivalent of the traditional paper-based [[laboratory notebook]], which historically has served as a collection of scribblings—often with individual, regional, or temporal idiosyncratic styles of "subjectivity, unruliness, and privacy"<ref name="HolmesArchRework03">{{cite book |title=Reworking the Bench - Research Notebooks in the History of Science |chapter=Introduction |series=Archimedes - New Studies in the History and Philosophy of Science and Technology |editor=Holmes, F.L.; Renn, J.; Rheinberger, H.-J. |publisher=Kluwer Academic Publishers |volume=7 |pages=vii–xv |year=2003 |isbn=9780306481529 |doi=10.1007/0-306-48152-9}}</ref>—concerning the notes and protocols of one or more particular scientific research endeavors.<ref name="NussbeckTheLab14" /><ref name="HolmesArchRework03" /> In recent times, these scribblings have become more recognizably organized and thorough as a necessary part of presenting all the details of experiments, observations, and analyses such that the results can be reproduced and verified by peers in the scientific community (often referred to as part of a broader "reproducibility crisis").<ref name="NussbeckTheLab14" /><ref name="DirnaglAPocket16" /><ref>{{Cite journal |last=Hunter |first=Philip |date=2017-09 |title=The reproducibility “crisis”: Reaction to replication crisis should not stifle innovation |url=https://www.embopress.org/doi/10.15252/embr.201744876 |journal=EMBO reports |language=en |volume=18 |issue=9 |pages=1493–1496 |doi=10.15252/embr.201744876 |issn=1469-221X |pmc=PMC5579390 |pmid=28794201}}</ref> As laboratory research has increasingly incorporated more digital sources of data and information from instruments and other sources, labs conducting laboratory notebook-assisted research today—in both academic and industrial environments—have had to necessarily look at old paper notebook formats as antiquated and incompatible with modern research methods and increasingly digitalized workflows.<ref name="NussbeckTheLab14" /><ref name="DirnaglAPocket16" />


Electronic lab notebooks used for development or research in regulated industries, such as medical devices or pharmaceuticals, are expected to comply with U.S. [[Food and Drug Administration]] (FDA) regulations related to software validation.<ref name="21CFR11">{{cite web|url=http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=11&showFR=1 |title=The Code of Federal Regulations Title 21 Part 11  |publisher=U.S. Food and Drug Administration |date=2010-04-01 |accessdate=2011-05-04}}</ref> The purpose of the regulations is to ensure the integrity of the entries in terms of time, authorship, and content. Unlike ELNs for patent protection, the FDA is not concerned with patent interference proceedings, but rather with avoidance of falsification.
As a modern substitute for the paper-based laboratory notebook, the ELN at its core intends to similarly provide a means to document experiments, observations, and analyses but in a more organized, consistent, readable, searchable, shareable, and legally defensible way. Because it is software, additional thought has gone into the development of an ELN to allow users to do their research more effectively while integrating with other digital instruments and software solutions to capture and manage data and information closer to real-time. As a result, today's ELNs take many shapes and forms, many of them being developed to address the needs of specific research activities, such as biology and DNA [[sequencing]]<ref name="BarillariOpenBIS16">{{Cite journal |last=Barillari |first=Caterina |last2=Ottoz |first2=Diana S. M. |last3=Fuentes-Serna |first3=Juan Mariano |last4=Ramakrishnan |first4=Chandrasekhar |last5=Rinn |first5=Bernd |last6=Rudolf |first6=Fabian |date=2016-02-15 |title=openBIS ELN-LIMS: an open-source database for academic laboratories |url=https://academic.oup.com/bioinformatics/article/32/4/638/1743839 |journal=Bioinformatics |language=en |volume=32 |issue=4 |pages=638–640 |doi=10.1093/bioinformatics/btv606 |issn=1367-4811 |pmc=PMC4743625 |pmid=26508761}}</ref><ref name="PlassUsing23">{{Cite journal |last=Plass |first=Fabian |last2=Englisch |first2=Silvan |last3=Apeleo Zubiri |first3=Benjamin |last4=Pflug |first4=Lukas |last5=Spiecker |first5=Erdmann |last6=Stingl |first6=Michael |date=2023-11-22 |title=Using OpenBIS&nbsp;as Virtual Research Environment: An ELN-LIMS Open-Source Database Tool as a Framework within the CRC 1411 Design of Particulate Products |url=https://account.datascience.codata.org/index.php/up-j-dsj/article/view/1500 |journal=Data Science Journal |volume=22 |pages=44 |doi=10.5334/dsj-2023-044 |issn=1683-1470}}</ref> or chemical analysis.<ref name="PlassUsing23" /><ref>{{Cite journal |last=Tremouilhac |first=Pierre |last2=Nguyen |first2=An |last3=Huang |first3=Yu-Chieh |last4=Kotov |first4=Serhii |last5=Lütjohann |first5=Dominic Sebastian |last6=Hübsch |first6=Florian |last7=Jung |first7=Nicole |last8=Bräse |first8=Stefan |date=2017-12 |title=Chemotion ELN: an Open Source electronic lab notebook for chemists in academia |url=https://jcheminf.biomedcentral.com/articles/10.1186/s13321-017-0240-0 |journal=Journal of Cheminformatics |language=en |volume=9 |issue=1 |pages=54 |doi=10.1186/s13321-017-0240-0 |issn=1758-2946 |pmc=PMC5612905 |pmid=29086216}}</ref>


Typical provisions related to software validation are included in the medical device regulations at 21 CFR 820 (et seq.) and [[21 CFR Part 11|21 CFR 11]].  Essentially, the requirements are that the software has been designed and implemented to be suitable for its intended purposes.  Evidence to show that this is the case is often provided by a software requirements specification (SRS) that lays out the intended uses and needs that the ELN will meet. The SRS typically includes one or more testing protocols that, when followed, demonstrate that the ELN meets the requirements of the specification and that the requirements are satisfied under worst-case conditions.  Security, audit trails, prevention of unauthorized changes without substantial collusion of otherwise independent personnel (i.e. those having no interest in the content of the ELN such as independent quality unit personnel) are all fundamental to the ELN. Finally, one or more reports demonstrating the results of the testing in accordance with the predefined protocols are required prior to release of the ELN software for use.  If the reports show that the software failed to satisfy any of the SRS requirements, then [[corrective and preventive action]] (CAPA) must be undertaken and documented.  Such CAPA may extend to minor software revisions, or changes in architecture or major revisions.  CAPA activities need to be documented as well.<ref>{{cite web|url=http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm170612.htm |title=Corrective and Preventive Actions (CAPA) |publisher=U.S. Food and Drug Administration |date=2010-06-28 |accessdate=2011-05-04}}</ref>
For academic and industry organizations both, getting stakeholder buy-in for the use of an ELN throughout the organization often comes with challenges. From the complexity of use and learning curve to personal cost, lack of vendor and institutional support, and organizational security policies, organizations seeking greater use of ELNs will likely need to change the research culture.<ref name="HigginsConsider22" /><ref name="FosterImplem22">{{Cite journal |last=Foster |first=Erin D. |last2=Whipple |first2=Elizabeth C. |last3=Rios |first3=Gabriel R. |date=2022-04-26 |title=Implementing an institution-wide electronic lab notebook initiative |url=https://jmla.pitt.edu/ojs/jmla/article/view/1407 |journal=Journal of the Medical Library Association |volume=110 |issue=2 |doi=10.5195/jmla.2022.1407 |issn=1558-9439 |pmc=PMC9014952 |pmid=35440896}}</ref> Developing sufficient infrastructure to enable use, providing an easy and efficient user interface, building a sense of community around ELNs to make them more normative, clearly providing information on the incentives and efficiency gains of ELNs while highlighting the rewards, and updating and balancing policy advising ELN use based on those incentives and efficiency gains provides structure to any initiative seeking to change the research culture.<ref name="FosterImplem22" />


==Modern features of an ELN==
==Modern features of an ELN==
ELNs are generally divided into two categories<ref name="SciCompWorld1" />:
ELNs are generally divided into two categories<ref name="SciCompWorld1" />:


* A "specific" ELN contains features designed to work within specific applications, scientific instrumentation, or data types.
*A "specific" ELN contains features designed to work within specific applications, scientific instrumentation, or data types.


* A cross-disciplinary or "generic" ELN is designed to support access to all data and information that needs to be recorded in a lab notebook.
*A cross-disciplinary or "generic" ELN is designed to support access to all data and information that needs to be recorded in a lab notebook.


Among these two general categories are ELNs that capture two particular markets: individual researchers and group research teams. ELNs can be tailored to one or both types of markets, with both groups and individuals benefiting from the ELN's inherent ability to add structure to research records. Groups utilizing an ELN typically require two additional abilities: to share research data and communicate about their research.<ref>{{cite web |url=http://www.researchspace.com/electronic-lab-notebook/blog/lab/?tag=record |archiveurl=https://web.archive.org/web/20170929193010/http://www.researchspace.com/electronic-lab-notebook/blog/lab/?tag=record |title=Are electronic lab notebooks for individuals or groups? |author=Macneil, R. |work=The electronic lab notebook blog |publisher=ResearchSpace/Axiope |date=11 November 2010 |archivedate=29 September 2017 |accessdate=21 March 2020}}</ref>


Among these two general categories are ELNs that capture two particular markets: individual researchers and group research teams. ELNs can be tailored to one or both types of markets, with both groups and individuals benefiting from the ELN's inherent ability to add structure to research records. Groups utilizing an ELN typically require two additional abilities: to share research data and communicate about their research.<ref>{{cite web|url=http://elnblog.axiope.com/?p=543 |title=Are electronic lab notebooks for individuals or groups? |publisher=Axiope |date=2010-11-11 |accessdate=2011-05-04}}</ref>
Modern features include, but are not limited to<ref name="NussbeckTheLab14" /><ref name="DirnaglAPocket16" /><ref name="HigginsConsider22" /><ref name="PlassUsing23" /><ref name="LoveluckFind20">{{Cite web |last=Loveluck, J. |date=08 October 2020 |title=Finding the Right Electronic Lab Notebook with the Corey Lab |work=Harvard Research Data Management |url=https://datamanagement.hms.harvard.edu/news/finding-right-electronic-lab-notebook-corey-lab |publisher=Harvard Medical School |accessdate=11 March 2024}}</ref><ref name="KanzaElect17">{{Cite journal |last=Kanza |first=Samantha |last2=Willoughby |first2=Cerys |last3=Gibbins |first3=Nicholas |last4=Whitby |first4=Richard |last5=Frey |first5=Jeremy Graham |last6=Erjavec |first6=Jana |last7=Zupančič |first7=Klemen |last8=Hren |first8=Matjaž |last9=Kovač |first9=Katarina |date=2017-12 |title=Electronic lab notebooks: can they replace paper? |url=https://jcheminf.biomedcentral.com/articles/10.1186/s13321-017-0221-3 |journal=Journal of Cheminformatics |language=en |volume=9 |issue=1 |pages=31 |doi=10.1186/s13321-017-0221-3 |issn=1758-2946 |pmc=PMC5443717 |pmid=29086051}}</ref><ref name="KnippenbergBest18">{{Cite web |last=Knippenberg, R. |title=Best Practices for Electronic Laboratory Notebook Implementation in R&D Labs |work=Astrix Insights |url=https://astrixinc.com/best-practices-for-electronic-laboratory-notebook-implementation-in-rd-labs/ |publisher=Astrix, Inc |archiveurl=https://web.archive.org/web/20231208184311/https://astrixinc.com/best-practices-for-electronic-laboratory-notebook-implementation-in-rd-labs/ |archivedate=08 December 2023 |date=30 June 2018 |accessdate=05 March 2024}}</ref><ref name="CoveyElectronic19">{{cite web |url=https://www.rockefeller.edu/markus-library/uploads/www.rockefeller.edu/sites/207/2019/05/Electronic-Notebooks-CCTS.pdf |format=PDF |title=Electronic Lab Notebooks: From paper to screen, keeping track of your research |author=Covey, M.; Goto, R.; Ceglia, I. |publisher=Rita and Frits Markus Library, Rockefeller University |date=May 2019 |accessdate=05 March 2024}}</ref><ref name=":2">{{Cite journal |last=Argento |first=Nicolas |date=2020-03-04 |title=Institutional ELN/LIMS deployment: Highly customizable ELN/LIMS platform as a cornerstone of digital transformation for life sciences research institutes |url=https://www.embopress.org/doi/10.15252/embr.201949862 |journal=EMBO reports |language=en |volume=21 |issue=3 |pages=e49862 |doi=10.15252/embr.201949862 |issn=1469-221X |pmc=PMC7054672 |pmid=32129000}}</ref>:


Modern features include, but are not limited to<ref>{{cite web|url=http://elnblog.axiope.com/?p=451 |title=What are electronic lab notebooks for? |publisher=Axiope |date=2010-10-06 |accessdate=2011-05-04}}</ref><ref>{{cite web|url=http://www.genengnews.com/gen-articles/lab-notebooks-offer-efficiency-gains/1951/ |title=Lab Notebooks Offer Efficiency Gains |publisher=Genetic Engineering & Biotechnology News |date=2006-12-01 |accessdate=2011-05-04}}</ref><ref>{{cite web|url=http://www.scientificcomputing.com/a-look-at-the-state-of-electronic.aspx |title=A Look at the State of Electronic Lab Notebook Technology |publisher=Scientific Computing |date=2008-10-09 |accessdate=2011-05-04}}</ref>:
*direct real-time recording of data and information in various (standard) formats like text, images, tables, chromatograms, and raw data files;
*robust support for tagging, searching, and reusing data, information, files, etc.;
*support for standard vocabularies and [[metadata]] schemes, including semantic enrichment schemes<ref name="PASemantic24">{{cite web |url=https://www.pistoiaalliance.org/projects/current-projects/semantic-enrichment-of-eln-data/ |title=Semantic Enrichment of Electronic Lab Notebook Data |author=Prior, D. |publisher=Pistoia Alliance |date=21 January 2024 |accessdate=06 March 2024}}</ref>;
*lending of structure to data and information through the use of preformatted or customizable templates with drag-and-drop support;
*flexible creation of links between records, including reference managers and other notebooks;
*group, project, and experiment management;
*import and export functionality, particularly in standard, portable file formats;
*storage of fully searchable records in a secure database format, with automatic backup;
*inclusion of messaging and commenting functionality for better collaboration;
*inclusion of safety data, including flags for dangerous chemicals;
*data integrity and security tools like electronic signatures, time-stamped audit logs, controlled access levels, version control, automated import of instrument data, and archiving capabilities;
*generation of secure forms that accept laboratory data input real-time via a computing device and/or laboratory equipment (i.e., integration);
*accommodation of a scheduling option for routine procedures such as equipment qualification and study-related timelines;
*support for standard chemical, genetic, and other molecular libraries, visualization, and nomenclature formats, e.g., LaTeX; and
*inventory management of instruments, reagents, samples, etc.
 
==Regulations and legal aspects==
ELNs used for research or development in regulated clinical industries, such as medical devices 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 trail]]s, signed records, and secured access to data.<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=08 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=08 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=08 March 2024}}</ref> Additionally, record keeping requirements of laboratory-related standards such as [[ISO/IEC 17025]] and [[ISO 15189]] place additional pressure on ELN vendors to supply functionality that helps ELN users better comply to accreditation to those standards.<ref name="HigginsConsider22" /> Regulations similar to 21 CFR Part 11 in other countries, such as Europe's Annex 11 and Japan's PFSB 040122, will also require similar demands from ELN.<ref name="RDEditorsAQuick12" /> However just because an ELN is electronic doesn't automatically make it secure and compliant with standards and regulations, putting the onus on adopters of the technology to validate the ELN to what it's purported to do.


* importation of data which has already been captured elsewhere
In addition to regulatory compliance, R&D organizations of all types using paper or electronic laboratory notebooks are concerned with the explicit protection of the data and information found in those notebooks, as well as in any other documents or electronic systems.<ref name="DeptaKnowledge15">{{Cite journal |last=Depta |first=Ryszard |date=2015 |title=Knowledge management in R&D centres, in the field of biomedicine, using contemporary information and communication technology and the methodology of continuous improvement |url=https://doi.org/10.14611/minib.17.03.2015.10 |journal=Marketing of Scientific and Research Organizations |volume=17 |issue=3 |pages=55–102 |doi=10.14611/minib.17.03.2015.10}}</ref> From prototypes of new products and technologies to proprietary recipes and more, protection of intellectual property for maintaining patentability and market share are important to organizations, and any ELNs containing such material must be designed with this in mind. Ensuring access to information on a "need to know" basis based upon role, security level, or location is useful toward legally protecting data and information in an ELN. Traceability and provenance mechanisms such as [[audit trail]]s and [[electronic signature]]s—which combined link an individual to one or more time-stamped actions—allow organizations employing ELNs to determine cases of unauthorized access, data and information destruction, and compromising of [[data integrity]]. Long-term archiving of records and authentication information is also an important aspect of ELNs and protecting data and information.<ref name="HigginsConsider22" /><ref name="DeptaKnowledge15" /><ref name="FlintonProving11">{{cite web |url=https://www.labmanager.com/proving-ownership-18567 |title=Proving Ownership |author=Flinton, R.P. |work=Lab Manager |date=05 June 2011 |accessdate=11 March 2024}}</ref><ref name="BirdLab13">{{Cite journal |last=Bird |first=Colin L. |last2=Willoughby |first2=Cerys |last3=Frey |first3=Jeremy G. |date=2013 |title=Laboratory notebooks in the digital era: the role of ELNs in record keeping for chemistry and other sciences |url=http://xlink.rsc.org/?DOI=c3cs60122f |journal=Chemical Society Reviews |language=en |volume=42 |issue=20 |pages=8157 |doi=10.1039/c3cs60122f |issn=0306-0012}}</ref>
* direct recording of data in various forms like text, images, and tables
* lending of structure to data and information through the use of preformatted or customizable templates which include a range of field types
* creation of links between records
* storage of fully searchable records in a secure database format
* inclusion of a messaging system for better collaboration
* a secure yet flexible environment to protect the integrity of both data and process while allowing for process changes
* generation of secure forms that accept laboratory data input via a computing device and/or laboratory equipment
* accommodation for networked or wireless communications
* a scheduling option for routine procedures such as equipment qualification and study-related timelines
* configurable qualification requirements


== References ==
==Further reading==
<references />
* {{cite journal |last=Higgins |first=Stuart G. |last2=Nogiwa-Valdez |first2=Akemi A. |last3=Stevens |first3=Molly M. |date=2022-02 |title=Considerations for implementing electronic laboratory notebooks in an academic research environment |url=https://www.nature.com/articles/s41596-021-00645-8 |journal=Nature Protocols |language=en |volume=17 |issue=2 |pages=179–189 |doi=10.1038/s41596-021-00645-8 |issn=1754-2189}}
* {{cite journal |title=Electronic lab notebooks: Can they replace paper? |journal=Journal of Cheminformatics |author=Kanza, S.; Willoughby, C.; Gibbins, N. et al. |volume=9 |pages=31 |year=2017 |doi=10.1186/s13321-017-0221-3 |pmc=PMC5443717}}
==References==
{{Reflist|colwidth=30em}}


== Further reading ==
<!---Place all category tags here-->
* [http://www.labcompliance.com/ LabCompliance News]
[[Category:Laboratory informatics]]
[[Category:Software systems]]

Latest revision as of 22:49, 11 March 2024

This article is about the general software replacement for laboratory notebooks. For other uses of the term "electronic laboratory notebook," "electronic lab notebook," or "ELN", see ELN.


Alexander Graham Bell's unpublished lab notebook, well before the invention of the ELN

An electronic laboratory notebook (also known as electronic lab notebook or ELN) is a software program or package designed to replace more traditional paper-based laboratory notebooks, which have for centuries been used by academic and industry researchers to document the procedures and results of experiments. ELNs in general are used by researchers to document, store, retrieve, and share fully electronic laboratory data and information—usually research-based—"in ways that meet all legal, regulatory, technical, and scientific requirements."[1] A well-designed ELN is also meant to act as legal documentation as well as scientific documentation, and it may be used in a court of law as evidence. Similar to an inventor's notebook, the lab notebook is also often referred to in patent prosecution and intellectual property litigation. Modern electronic lab notebooks have the advantage of being easier to search and share, better supporting collaboration among many users, and being more secure than their paper counterparts. However, the transition from paper-based laboratory notebooks to electronic versions can present a number of challenges to organizations, particularly in regards to researchers rejecting their use as being too time-consuming to learn, too difficult to use, and insufficient to meeting their needs.

History of the ELN

While some credit Dr. Keith Caserta with the concept of an electronic version of the laboratory notebook[2], it's likely that others had similar early ideas on how to integrate computing into the process of laboratory note taking.[3] Significant discussion concerning the transition from a pen-and-paper laboratory notebook to an electronic format was already in full swing in the early 1990s. During the 206th National Meeting of the American Chemical Society in August of 1993, an entire day of the conference was dedicated to talking about "electronic notebooks" and ELNs.[4] "A tetherless electronic equivalent of the paper notebook would be welcomed by the working scientist," noted Virginia Polytechnic Institute's Dr. Raymond E. Dessy for the conference.[2] Dessy had in the mid-1980s begun postulating on the idea of an electronic notebook, and by 1994 he provided one of the first working examples of an ELN.[5]

By 1997, a special interest group called the Collaborative Electronic Notebook Systems Association (CENSA) formed. Supported by 11 major pharmaceutical and chemical companies, the consortium worked with scientific software and hardware vendors to facilitate the creation of an ELN that met the technical and regulatory needs of its members.[6] The consortium at that time envisioned a collaborative ELN that "teams of scientists worldwide can use to reliably capture, manage, securely share, and permanently archive and retrieve all common data and records generated by research and development and testing labs."[7] That same year development of an enterprise-wide ELN at Kodak's research facilities in England was in full swing. The Kodak ELN was "implemented as a collection of Lotus Notes databases and applications," making it arguably one of the first enterprise ELN solutions in use at the time.[8]

In 1998 one of the first web-based versions of an ELN was introduced in the form of the University of Oregon's Virtual Notebook Environment (ViNE), "a platform-independent, web-based interface designed to support a range of scientific activities across distributed, heterogeneous computing platforms."[9] This innovation would go on to inspire vendors in the 2000s to develop web-based thin-client ELNs for laboratories everywhere. Yet it likely wasn't until the Electronic Signatures in Global and National Commerce Act (ESIGN) in June 2000 that the true legal implications of what a fully electronic laboratory notebook would have on the industry. If an ELN were to be responsible for providing validation during the patent processes and be valid for other types of audits, a mechanism for authenticating the origin of the ideas would be necessary. The ESIGN act meant that electronic records could be authenticated and digital signatures made legally binding, lending further relevancy to ELNs. Instead of searching through notebooks and piles of documents, printing material, and submitting thousands of pages for an FDA audit, ELN users could suddenly collate and submit electronic records, saving time and headaches.[1]

Enthusiasm for ELNs began to pick up again in the early 2000s, with a strong case for further data integration into ELNs being made at the CENSA-supported International Quality & Productivity Center (IQPC) conference in London during September 2004. During that conference the push for stronger data integration was made, with the base premise that "ELNs would improve corporate strategy by allowing information to be used more intelligently with the help of decision-support software."[10] By early 2007, industry-specific ELNs were pushing growth in the market: Scientific Computing World estimated 83 percent of related organizations declaring interest in ELNs, with 43 percent of those organizations seriously considering an evaluation or purchase.[11]

Despite the beginnings of an economic downturn in the late 2000s, Atrium Research later estimated that the ELN's market potential was around $1.7 billion.[12][13] During this time, scientists and academics—traditionally slow to adopt technological change—were gradually warming up to the benefits of an ELN. Academics in particular realized the problems the high turnover postdoc rate created in research laboratories. Postdocs would depart from the university, leaving PIs and directors scratching their heads on where the data ended up. ELNs changed that, allowing much more persistent data that can be found and referenced even after a postdoc departs.[14]

The movement towards ELN integration into other laboratory functions during the 2000s eventually led to the blurring of what an ELN actually is. In early 2007, Scientific Computing World reported that the definition of an ELN varied among scientists, with 35 percent of them stating they were "clear about the difference between a [laboratory information management system (LIMS)] and an ELN."[11] Today, it's possible to see in some vendors' offerings the formerly distinct entity that was an ELN to now be completely integrated into a LIMS. As of 2024, ELNs can be found as standalone solutions or as integrated modules of some other software like a LIMS, running as locally installed software or in the cloud under the software as a service model.

As modern laboratory research has increasingly incorporated more digital sources of data and information from instruments and other sources, labs conducting laboratory notebook-assisted research today—in both academic and industrial environments—have had to necessarily look at old paper notebook formats as antiquated and incompatible with modern research methods and increasingly digitalized workflows.[15][16] With this greater need for an ELN, the ELN market was predicted in 2022 by Verified Market Research to reach nearly $795 million by 2028, below Atrium's late 2000s predictions but gaining ground again, with "the increasing need for data stored electronically ... imposing an assertive impact factor on the market."[17] However, as ELNs have become more complex, often taking on additional functionality found in other laboratory systems like the LIMS, there has come with it a greater chance of overall cost and complexity of use increasing, in turn negatively impacting overall adoption of the ELN by laboratorians.[16] As such, complex modern ELNs have needed to be more intuitive, easy-to-learn, and well-documented in order to better ensure full adoption.[18]

Use of an ELN

An ELN is a modern electronic equivalent of the traditional paper-based laboratory notebook, which historically has served as a collection of scribblings—often with individual, regional, or temporal idiosyncratic styles of "subjectivity, unruliness, and privacy"[19]—concerning the notes and protocols of one or more particular scientific research endeavors.[15][19] In recent times, these scribblings have become more recognizably organized and thorough as a necessary part of presenting all the details of experiments, observations, and analyses such that the results can be reproduced and verified by peers in the scientific community (often referred to as part of a broader "reproducibility crisis").[15][16][20] As laboratory research has increasingly incorporated more digital sources of data and information from instruments and other sources, labs conducting laboratory notebook-assisted research today—in both academic and industrial environments—have had to necessarily look at old paper notebook formats as antiquated and incompatible with modern research methods and increasingly digitalized workflows.[15][16]

As a modern substitute for the paper-based laboratory notebook, the ELN at its core intends to similarly provide a means to document experiments, observations, and analyses but in a more organized, consistent, readable, searchable, shareable, and legally defensible way. Because it is software, additional thought has gone into the development of an ELN to allow users to do their research more effectively while integrating with other digital instruments and software solutions to capture and manage data and information closer to real-time. As a result, today's ELNs take many shapes and forms, many of them being developed to address the needs of specific research activities, such as biology and DNA sequencing[21][22] or chemical analysis.[22][23]

For academic and industry organizations both, getting stakeholder buy-in for the use of an ELN throughout the organization often comes with challenges. From the complexity of use and learning curve to personal cost, lack of vendor and institutional support, and organizational security policies, organizations seeking greater use of ELNs will likely need to change the research culture.[18][24] Developing sufficient infrastructure to enable use, providing an easy and efficient user interface, building a sense of community around ELNs to make them more normative, clearly providing information on the incentives and efficiency gains of ELNs while highlighting the rewards, and updating and balancing policy advising ELN use based on those incentives and efficiency gains provides structure to any initiative seeking to change the research culture.[24]

Modern features of an ELN

ELNs are generally divided into two categories[11]:

  • A "specific" ELN contains features designed to work within specific applications, scientific instrumentation, or data types.
  • A cross-disciplinary or "generic" ELN is designed to support access to all data and information that needs to be recorded in a lab notebook.

Among these two general categories are ELNs that capture two particular markets: individual researchers and group research teams. ELNs can be tailored to one or both types of markets, with both groups and individuals benefiting from the ELN's inherent ability to add structure to research records. Groups utilizing an ELN typically require two additional abilities: to share research data and communicate about their research.[25]

Modern features include, but are not limited to[15][16][18][22][26][27][28][29][30]:

  • direct real-time recording of data and information in various (standard) formats like text, images, tables, chromatograms, and raw data files;
  • robust support for tagging, searching, and reusing data, information, files, etc.;
  • support for standard vocabularies and metadata schemes, including semantic enrichment schemes[31];
  • lending of structure to data and information through the use of preformatted or customizable templates with drag-and-drop support;
  • flexible creation of links between records, including reference managers and other notebooks;
  • group, project, and experiment management;
  • import and export functionality, particularly in standard, portable file formats;
  • storage of fully searchable records in a secure database format, with automatic backup;
  • inclusion of messaging and commenting functionality for better collaboration;
  • inclusion of safety data, including flags for dangerous chemicals;
  • data integrity and security tools like electronic signatures, time-stamped audit logs, controlled access levels, version control, automated import of instrument data, and archiving capabilities;
  • generation of secure forms that accept laboratory data input real-time via a computing device and/or laboratory equipment (i.e., integration);
  • accommodation of a scheduling option for routine procedures such as equipment qualification and study-related timelines;
  • support for standard chemical, genetic, and other molecular libraries, visualization, and nomenclature formats, e.g., LaTeX; and
  • inventory management of instruments, reagents, samples, etc.

Regulations and legal aspects

ELNs used for research or development in regulated clinical industries, such as medical devices 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.[32][33][34] Additionally, record keeping requirements of laboratory-related standards such as ISO/IEC 17025 and ISO 15189 place additional pressure on ELN vendors to supply functionality that helps ELN users better comply to accreditation to those standards.[18] Regulations similar to 21 CFR Part 11 in other countries, such as Europe's Annex 11 and Japan's PFSB 040122, will also require similar demands from ELN.[33] However just because an ELN is electronic doesn't automatically make it secure and compliant with standards and regulations, putting the onus on adopters of the technology to validate the ELN to what it's purported to do.

In addition to regulatory compliance, R&D organizations of all types using paper or electronic laboratory notebooks are concerned with the explicit protection of the data and information found in those notebooks, as well as in any other documents or electronic systems.[35] From prototypes of new products and technologies to proprietary recipes and more, protection of intellectual property for maintaining patentability and market share are important to organizations, and any ELNs containing such material must be designed with this in mind. Ensuring access to information on a "need to know" basis based upon role, security level, or location is useful toward legally protecting data and information in an ELN. Traceability and provenance mechanisms such as audit trails and electronic signatures—which combined link an individual to one or more time-stamped actions—allow organizations employing ELNs to determine cases of unauthorized access, data and information destruction, and compromising of data integrity. Long-term archiving of records and authentication information is also an important aspect of ELNs and protecting data and information.[18][35][36][37]

Further reading

References

  1. ↑ 1.0 1.1 Zall, M. (2001). "The nascent paperless laboratory". Chemical Innovation 31 (2): 14–21. http://pubsapp.acs.org/subscribe/archive/ci/31/i02/html/02zall.html. 
  2. ↑ 2.0 2.1 Matthews, M., ed. (1993). "Meeting Program Division of Chemical Education". Chemical Information Bulletin 45 (3): 64. https://digital.library.unt.edu/ark:/67531/metadc5647/m1/48/. 
  3. ↑ Rumpf, W.. "My ELN Life". Wolfgang Rumpf, Ph.D. Archived from the original on 15 May 2011. http://web.archive.org/web/20110515133816/http://web.me.com/evildrbob/Site/My_ELN_Life/My_ELN_Life.html. Retrieved 08 March 2024. 
  4. ↑ Matthews, M., ed. (1993). "Meeting Program Division of Chemical Education". Chemical Information Bulletin 45 (3): 46. https://digital.library.unt.edu/ark:/67531/metadc5647/m1/48/. 
  5. ↑ Borman, S. (1994). "Electronic Laboratory Notebooks May Revolutionize Research Record Keeping". Chemical Engineering News 72 (21): 10–20. doi:10.1021/cen-v072n021.p010. https://pubs.acs.org/toc/cenear/72/21. 
  6. ↑ Lysakowski, R. (1997). "The Collaborative Electronic Notebook Systems Consortium". Proceedings of the 19th Annual International Conference of the IEEE Engineering in Medicine and Biology Society 6: 2659–2661. doi:10.1109/IEMBS.1997.756879. 
  7. ↑ Chandler, R.L. (1997). Documenting the Biotechnology Industry in the San Francisco Bay Area. University of California - San Diego Libraries. p. 40. https://escholarship.org/uc/item/1m24k447#page-40. Retrieved 21 March 2020. 
  8. ↑ McLaughlin, D.R. (1999). "Chapter 11: The Wired Laboratory". Impact of Advances in Computing and Communications Technologies on Chemical Science and Technology: Report of a Workshop. National Academy Press. pp. 164. ISBN 0309065771. https://www.nap.edu/read/9591/chapter/15#164. 
  9. ↑ Skidmore, J.L.; Sottile, M.J.; Cuny, J.E.; Malony, A.D. (1998). "A Prototype Notebook-Based Environment for Computational Tools Computational Tools". Proceedings of the 1998 ACM/IEEE conference on Supercomputing: 22. doi:10.1109/SC.1998.10031. 
  10. ↑ Rees, P. (1 November 2004). "How to capture data to share". Scientific Computing World. Europa Science. https://www.scientific-computing.com/feature/how-capture-data-share. Retrieved 08 March 2024. 
  11. ↑ 11.0 11.1 11.2 Elliot, M.H. (1 December 2006). "The state of the ELN Market". Scientific Computing World. Europa Science. https://www.scientific-computing.com/feature/state-eln-market. Retrieved 08 March 2024. 
  12. ↑ "Atrium Research Announces Fourth Edition of Landmark Report on Electronic Laboratory Notebooks". Atrium Research. 2 June 2009. http://www.atriumresearch.com/html/PR/pr060109.htm. Retrieved 04 May 2011. [dead link]
  13. ↑ "Atrium Research Announces the Third Edition of Landmark Report on Electronic Laboratory Notebooks". LIMSfinder.org. 7 May 2007. Archived from the original on 08 September 2007. https://web.archive.org/web/20070908031324/http://www.limsfinder.com/BlogDetail.aspx?id=32062_0_3_0_C. Retrieved 21 March 2020. 
  14. ↑ Dance, A. (2010). "Digital Upgrade: How to choose your lab's next electronic lab notebook". The Scientist 24 (5): 71. https://www.the-scientist.com/digital-upgrade-43342. 
  15. ↑ 15.0 15.1 15.2 15.3 15.4 Nussbeck, Sara Y; Weil, Philipp; Menzel, Julia; Marzec, Bartlomiej; Lorberg, Kai; Schwappach, Blanche (2014). "The laboratory notebook in the 21 st century: The electronic laboratory notebook would enhance good scientific practice and increase research productivity" (in en). EMBO reports 15 (6): 631–634. doi:10.15252/embr.201338358. ISSN 1469-221X. PMC PMC4197872. PMID 24833749. https://www.embopress.org/doi/10.15252/embr.201338358. 
  16. ↑ 16.0 16.1 16.2 16.3 16.4 Dirnagl, Ulrich; Przesdzing, Ingo (4 January 2016). "A pocket guide to electronic laboratory notebooks in the academic life sciences" (in en). F1000Research 5: 2. doi:10.12688/f1000research.7628.1. ISSN 2046-1402. PMC PMC4722687. PMID 26835004. https://f1000research.com/articles/5-2/v1. 
  17. ↑ "Electronic Lab Notebook (ELN) Market Size And Forecast". Verified Market Research. May 2022. https://www.verifiedmarketresearch.com/product/electronic-lab-notebook-eln-market/. Retrieved 08 March 2024. 
  18. ↑ 18.0 18.1 18.2 18.3 18.4 Higgins, Stuart G.; Nogiwa-Valdez, Akemi A.; Stevens, Molly M. (1 February 2022). "Considerations for implementing electronic laboratory notebooks in an academic research environment" (in en). Nature Protocols 17 (2): 179–189. doi:10.1038/s41596-021-00645-8. ISSN 1754-2189. https://www.nature.com/articles/s41596-021-00645-8. 
  19. ↑ 19.0 19.1 Holmes, F.L.; Renn, J.; Rheinberger, H.-J., ed. (2003). "Introduction". Reworking the Bench - Research Notebooks in the History of Science. Archimedes - New Studies in the History and Philosophy of Science and Technology. 7. Kluwer Academic Publishers. pp. vii–xv. doi:10.1007/0-306-48152-9. ISBN 9780306481529. 
  20. ↑ Hunter, Philip (1 September 2017). "The reproducibility “crisis”: Reaction to replication crisis should not stifle innovation" (in en). EMBO reports 18 (9): 1493–1496. doi:10.15252/embr.201744876. ISSN 1469-221X. PMC PMC5579390. PMID 28794201. https://www.embopress.org/doi/10.15252/embr.201744876. 
  21. ↑ Barillari, Caterina; Ottoz, Diana S. M.; Fuentes-Serna, Juan Mariano; Ramakrishnan, Chandrasekhar; Rinn, Bernd; Rudolf, Fabian (15 February 2016). "openBIS ELN-LIMS: an open-source database for academic laboratories" (in en). Bioinformatics 32 (4): 638–640. doi:10.1093/bioinformatics/btv606. ISSN 1367-4811. PMC PMC4743625. PMID 26508761. https://academic.oup.com/bioinformatics/article/32/4/638/1743839. 
  22. ↑ 22.0 22.1 22.2 Plass, Fabian; Englisch, Silvan; Apeleo Zubiri, Benjamin; Pflug, Lukas; Spiecker, Erdmann; Stingl, Michael (22 November 2023). "Using OpenBIS as Virtual Research Environment: An ELN-LIMS Open-Source Database Tool as a Framework within the CRC 1411 Design of Particulate Products". Data Science Journal 22: 44. doi:10.5334/dsj-2023-044. ISSN 1683-1470. https://account.datascience.codata.org/index.php/up-j-dsj/article/view/1500. 
  23. ↑ Tremouilhac, Pierre; Nguyen, An; Huang, Yu-Chieh; Kotov, Serhii; Lütjohann, Dominic Sebastian; Hübsch, Florian; Jung, Nicole; Bräse, Stefan (1 December 2017). "Chemotion ELN: an Open Source electronic lab notebook for chemists in academia" (in en). Journal of Cheminformatics 9 (1): 54. doi:10.1186/s13321-017-0240-0. ISSN 1758-2946. PMC PMC5612905. PMID 29086216. https://jcheminf.biomedcentral.com/articles/10.1186/s13321-017-0240-0. 
  24. ↑ 24.0 24.1 Foster, Erin D.; Whipple, Elizabeth C.; Rios, Gabriel R. (26 April 2022). "Implementing an institution-wide electronic lab notebook initiative". Journal of the Medical Library Association 110 (2). doi:10.5195/jmla.2022.1407. ISSN 1558-9439. PMC PMC9014952. PMID 35440896. https://jmla.pitt.edu/ojs/jmla/article/view/1407. 
  25. ↑ Macneil, R. (11 November 2010). "Are electronic lab notebooks for individuals or groups?". The electronic lab notebook blog. ResearchSpace/Axiope. Archived from the original on 29 September 2017. https://web.archive.org/web/20170929193010/http://www.researchspace.com/electronic-lab-notebook/blog/lab/?tag=record. Retrieved 21 March 2020. 
  26. ↑ Loveluck, J. (8 October 2020). "Finding the Right Electronic Lab Notebook with the Corey Lab". Harvard Research Data Management. Harvard Medical School. https://datamanagement.hms.harvard.edu/news/finding-right-electronic-lab-notebook-corey-lab. Retrieved 11 March 2024. 
  27. ↑ Kanza, Samantha; Willoughby, Cerys; Gibbins, Nicholas; Whitby, Richard; Frey, Jeremy Graham; Erjavec, Jana; Zupančič, Klemen; Hren, Matjaž et al. (1 December 2017). "Electronic lab notebooks: can they replace paper?" (in en). Journal of Cheminformatics 9 (1): 31. doi:10.1186/s13321-017-0221-3. ISSN 1758-2946. PMC PMC5443717. PMID 29086051. https://jcheminf.biomedcentral.com/articles/10.1186/s13321-017-0221-3. 
  28. ↑ Knippenberg, R. (30 June 2018). "Best Practices for Electronic Laboratory Notebook Implementation in R&D Labs". Astrix Insights. Astrix, Inc. Archived from the original on 08 December 2023. https://web.archive.org/web/20231208184311/https://astrixinc.com/best-practices-for-electronic-laboratory-notebook-implementation-in-rd-labs/. Retrieved 05 March 2024. 
  29. ↑ Covey, M.; Goto, R.; Ceglia, I. (May 2019). "Electronic Lab Notebooks: From paper to screen, keeping track of your research" (PDF). Rita and Frits Markus Library, Rockefeller University. https://www.rockefeller.edu/markus-library/uploads/www.rockefeller.edu/sites/207/2019/05/Electronic-Notebooks-CCTS.pdf. Retrieved 05 March 2024. 
  30. ↑ Argento, Nicolas (4 March 2020). "Institutional ELN/LIMS deployment: Highly customizable ELN/LIMS platform as a cornerstone of digital transformation for life sciences research institutes" (in en). EMBO reports 21 (3): e49862. doi:10.15252/embr.201949862. ISSN 1469-221X. PMC PMC7054672. PMID 32129000. https://www.embopress.org/doi/10.15252/embr.201949862. 
  31. ↑ Prior, D. (21 January 2024). "Semantic Enrichment of Electronic Lab Notebook Data". Pistoia Alliance. https://www.pistoiaalliance.org/projects/current-projects/semantic-enrichment-of-eln-data/. Retrieved 06 March 2024. 
  32. ↑ "CFR - Code of Federal Regulations Title 21, Part 11 Electronic Records; Electronic Signatures". U.S. Food and Drug Administration. 22 December 2023. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=11&showFR=1. Retrieved 08 March 2024. 
  33. ↑ 33.0 33.1 R&D Editors (10 May 2012). "A Quick Guide to ELN Regulatory Requirements". R&D World. https://www.rdworldonline.com/a-quick-guide-to-eln-regulatory-requirements/. Retrieved 08 March 2024. 
  34. ↑ "Whitepaper: FDA's 21 CFR Part 11" (PDF). Labforward GmbH. January 2020. https://labfolder.com/wp-content/uploads/2020/01/Labfolder-CFR21-Part11-Whitepaper.docx-2.pdf. Retrieved 08 March 2024. 
  35. ↑ 35.0 35.1 Depta, Ryszard (2015). "Knowledge management in R&D centres, in the field of biomedicine, using contemporary information and communication technology and the methodology of continuous improvement". Marketing of Scientific and Research Organizations 17 (3): 55–102. doi:10.14611/minib.17.03.2015.10. https://doi.org/10.14611/minib.17.03.2015.10. 
  36. ↑ Flinton, R.P. (5 June 2011). "Proving Ownership". Lab Manager. https://www.labmanager.com/proving-ownership-18567. Retrieved 11 March 2024. 
  37. ↑ Bird, Colin L.; Willoughby, Cerys; Frey, Jeremy G. (2013). "Laboratory notebooks in the digital era: the role of ELNs in record keeping for chemistry and other sciences" (in en). Chemical Society Reviews 42 (20): 8157. doi:10.1039/c3cs60122f. ISSN 0306-0012. http://xlink.rsc.org/?DOI=c3cs60122f. 
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