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Electronic lab notebook

February 06, 2023

An electronic lab notebook (also known as electronic laboratory notebook, or ELN) is a computer program designed to replace paper laboratory notebooks. Lab notebooks in general are used by scientists, engineers, and technicians to document research, experiments, and procedures performed in a laboratory. A lab 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.

Electronic lab notebooks offer many benefits to the user as well as organizations; they are easier to search upon, simplify data copying and backups, and support collaboration amongst many users.[1] ELNs can have fine-grained access controls, and can be more secure than their paper counterparts.[2] They also allow the direct incorporation of data from instruments, replacing the practice of printing out data to be stapled into a paper notebook.[3]

Types

ELNs can be divided into two categories:

  • "Specific ELNs" contain features designed to work with specific applications, scientific instrumentation or data types.
  • "Cross-disciplinary ELNs" or "Generic ELNs" are designed to support access to all data and information that needs to be recorded in a lab notebook.

Solutions range from specialized programs designed from the ground up for use as an ELN, to modifications or direct use of more general programs. Examples of using more general software include using OpenWetWare, a MediaWiki install (running the same software that Wikipedia uses), as an ELN, or the use of general note taking software such as OneNote as an ELN.[3]

ELN's come in many different forms. They can be standalone programs, use a client-server model, or be entirely web-based. Some use a lab-notebook approach, others resemble a blog.

A good many variations on the "ELN" acronym have appeared.[4] Differences between systems with different names are often subtle, with considerable functional overlap between them. Examples include "ERN" (Electronic Research Notebook), "ERMS" (Electronic Resource (or Research or Records) Management System (or Software) and SDMS (Scientific Data (or Document) Management System (or Software). Ultimately, these types of systems all strive to do the same thing: Capture, record, centralize and protect scientific data in a way that is highly searchable, historically accurate, and legally stringent, and which also promotes secure collaboration, greater efficiency, reduced mistakes and lowered total research costs.

Objectives

A good electronic laboratory notebook should offer a secure environment to protect the integrity of both data and process, whilst also affording the flexibility to adopt new processes or changes to existing processes without recourse to further software development. The package architecture should be a modular design, so as to offer the benefit of minimizing validation costs of any subsequent changes that you may wish to make in the future as your needs change.

A good electronic laboratory notebook should be an "out of the box" solution that, as standard, has fully configurable forms to comply with the requirements of regulated analytical groups through to a sophisticated ELN for inclusion of structures, spectra, chromatograms, pictures, text, etc. where a preconfigured form is less appropriate. All data within the system may be stored in a database (e.g. MySQL, MS-SQL, Oracle) and be fully searchable. The system should enable data to be collected, stored and retrieved through any combination of forms or ELN that best meets the requirements of the user.

The application should enable secure forms to be generated that accept laboratory data input via PCs and/or laptops / palmtops, and should be directly linked to electronic devices such as laboratory balances, pH meters, etc. Networked or wireless communications should be accommodated for by the package which will allow data to be interrogated, tabulated, checked, approved, stored and archived to comply with the latest regulatory guidance and legislation. A system should also include a scheduling option for routine procedures such as equipment qualification and study related timelines. It should include configurable qualification requirements to automatically verify that instruments have been cleaned and calibrated within a specified time period, that reagents have been quality-checked and have not expired, and that workers are trained and authorized to use the equipment and perform the procedures.

Regulatory and legal aspects

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.[5]

Electronic lab notebooks used for development or research in regulated industries, such as medical devices or pharmaceuticals, are expected to comply with FDA regulations related to software validation. 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, FDA is not concerned with patent interference proceedings, but is concerned with avoidance of falsification. Typical provisions related to software validation are included in the medical device regulations at 21 CFR 820 (et seq.)[6] and Title 21 CFR Part 11.[7] 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) setting forth the intended uses and the needs that the ELN will meet; 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) and similar tests are fundamental. 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.

Aside from the requirements to follow such steps for regulated industry, such an approach is generally a good practice in terms of development and release of any software to assure its quality and fitness for use. There are standards related to software development and testing that can be applied (see ref.).

See also

References

  1. ^ Myers, James; Elena Mendoza; Bonnie Hoopes (2001). A Collaborative Electronic Notebook. Proceedings of the IASTED International Conference on Internet and Multimedia Systems and Applications.
  2. ^ Myers, James (2003). (PDF). Proceedings of the 2003 International Symposium on Collaborative Technologies and Systems. Archived from the original (PDF) on 2011-10-15. Retrieved 2011-12-12.
  3. ^ a b Perkel, J. M. (2011). "Coding your way out of a problem". Nature Methods. 8 (7): 541–543. doi:10.1038/nmeth.1631. PMID 21716280. S2CID 13175560.
  4. ^ "Labii ELN & LIMS". 2017-04-30. Retrieved 2017-04-30."Lab Notebook (ELN) Glossary - CERF". 2016-02-16. Retrieved 2016-08-20.
  5. ^ "ISO/IEC 17025:2005 - General Requirements for the Competence of Testing and Calibration Laboratories." ISO - International Organization for Standardization. Web. 16 Nov. 2011. <http://www.iso.org/iso/Catalogue_detail?csnumber=39883>.
  6. ^ United States. Food and Drug Administration. Department of Health and Human Resources. 1 Food and Drugs - Subchapter H Medical Devices - Part 820 System RegCode of Federal Regulations - Title 2ulation. FDA.gov, 7 Oct. 1996. Web. <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=820>.
  7. ^ United States. Food and Drug Administration. Department of Health and Human Resources. Code of Federal Regulations - Title 21 Part 11 Electronic Records; Electronic Signatures. FDA.gov. Authority: 21 U.S.C. 321-393; 42 U.S.C. 262., 20 Mar. 1997. Web. 16 Nov. 2011. <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=11>.

Further reading

  • Taylor, K. T. (2006). "The status of electronic laboratory notebooks for chemistry and biology". Current Opinion in Drug Discovery & Development. 9 (3): 348–353. PMID 16729731.
  • Rubacha, M.; Rattan, A. K.; Hosselet, S. C. (2011). "A Review of Electronic Laboratory Notebooks Available in the Market Today". Journal of Laboratory Automation. 16 (1): 90–98. doi:10.1016/j.jala.2009.01.002. PMID 21609689.

February 06, 2023
electronic, notebook, electronic, notebook, also, known, electronic, laboratory, notebook, computer, program, designed, replace, paper, laboratory, notebooks, notebooks, general, used, scientists, engineers, technicians, document, research, experiments, proced. An electronic lab notebook also known as electronic laboratory notebook or ELN is a computer program designed to replace paper laboratory notebooks Lab notebooks in general are used by scientists engineers and technicians to document research experiments and procedures performed in a laboratory A lab 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 Electronic lab notebooks offer many benefits to the user as well as organizations they are easier to search upon simplify data copying and backups and support collaboration amongst many users 1 ELNs can have fine grained access controls and can be more secure than their paper counterparts 2 They also allow the direct incorporation of data from instruments replacing the practice of printing out data to be stapled into a paper notebook 3 Contents 1 Types 2 Objectives 3 Regulatory and legal aspects 4 See also 5 References 6 Further readingTypes EditELNs can be divided into two categories Specific ELNs contain features designed to work with specific applications scientific instrumentation or data types Cross disciplinary ELNs or Generic ELNs are designed to support access to all data and information that needs to be recorded in a lab notebook Solutions range from specialized programs designed from the ground up for use as an ELN to modifications or direct use of more general programs Examples of using more general software include using OpenWetWare a MediaWiki install running the same software that Wikipedia uses as an ELN or the use of general note taking software such as OneNote as an ELN 3 ELN s come in many different forms They can be standalone programs use a client server model or be entirely web based Some use a lab notebook approach others resemble a blog A good many variations on the ELN acronym have appeared 4 Differences between systems with different names are often subtle with considerable functional overlap between them Examples include ERN Electronic Research Notebook ERMS Electronic Resource or Research or Records Management System or Software and SDMS Scientific Data or Document Management System or Software Ultimately these types of systems all strive to do the same thing Capture record centralize and protect scientific data in a way that is highly searchable historically accurate and legally stringent and which also promotes secure collaboration greater efficiency reduced mistakes and lowered total research costs Objectives EditA good electronic laboratory notebook should offer a secure environment to protect the integrity of both data and process whilst also affording the flexibility to adopt new processes or changes to existing processes without recourse to further software development The package architecture should be a modular design so as to offer the benefit of minimizing validation costs of any subsequent changes that you may wish to make in the future as your needs change A good electronic laboratory notebook should be an out of the box solution that as standard has fully configurable forms to comply with the requirements of regulated analytical groups through to a sophisticated ELN for inclusion of structures spectra chromatograms pictures text etc where a preconfigured form is less appropriate All data within the system may be stored in a database e g MySQL MS SQL Oracle and be fully searchable The system should enable data to be collected stored and retrieved through any combination of forms or ELN that best meets the requirements of the user The application should enable secure forms to be generated that accept laboratory data input via PCs and or laptops palmtops and should be directly linked to electronic devices such as laboratory balances pH meters etc Networked or wireless communications should be accommodated for by the package which will allow data to be interrogated tabulated checked approved stored and archived to comply with the latest regulatory guidance and legislation A system should also include a scheduling option for routine procedures such as equipment qualification and study related timelines It should include configurable qualification requirements to automatically verify that instruments have been cleaned and calibrated within a specified time period that reagents have been quality checked and have not expired and that workers are trained and authorized to use the equipment and perform the procedures Regulatory and legal aspects EditThe 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 5 Electronic lab notebooks used for development or research in regulated industries such as medical devices or pharmaceuticals are expected to comply with FDA regulations related to software validation 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 FDA is not concerned with patent interference proceedings but is concerned with avoidance of falsification Typical provisions related to software validation are included in the medical device regulations at 21 CFR 820 et seq 6 and Title 21 CFR Part 11 7 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 setting forth the intended uses and the needs that the ELN will meet 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 and similar tests are fundamental 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 Aside from the requirements to follow such steps for regulated industry such an approach is generally a good practice in terms of development and release of any software to assure its quality and fitness for use There are standards related to software development and testing that can be applied see ref See also EditList of ELN software packages Data management Laboratory informatics JupyterReferences Edit Myers James Elena Mendoza Bonnie Hoopes 2001 A Collaborative Electronic Notebook Proceedings of the IASTED International Conference on Internet and Multimedia Systems and Applications Myers James 2003 Collaborative Electronic Notebooks as Electronic Records Design Issues for the Secure Electronic Laboratory Notebook ELN PDF Proceedings of the 2003 International Symposium on Collaborative Technologies and Systems Archived from the original PDF on 2011 10 15 Retrieved 2011 12 12 a b Perkel J M 2011 Coding your way out of a problem Nature Methods 8 7 541 543 doi 10 1038 nmeth 1631 PMID 21716280 S2CID 13175560 Labii ELN amp LIMS 2017 04 30 Retrieved 2017 04 30 Lab Notebook ELN Glossary CERF 2016 02 16 Retrieved 2016 08 20 ISO IEC 17025 2005 General Requirements for the Competence of Testing and Calibration Laboratories ISO International Organization for Standardization Web 16 Nov 2011 lt http www iso org iso Catalogue detail csnumber 39883 gt United States Food and Drug Administration Department of Health and Human Resources 1 Food and Drugs Subchapter H Medical Devices Part 820 System RegCode of Federal Regulations Title 2ulation FDA gov 7 Oct 1996 Web lt http www accessdata fda gov scripts cdrh cfdocs cfcfr cfrsearch cfm cfrpart 820 gt United States Food and Drug Administration Department of Health and Human Resources Code of Federal Regulations Title 21 Part 11 Electronic Records Electronic Signatures FDA gov Authority 21 U S C 321 393 42 U S C 262 20 Mar 1997 Web 16 Nov 2011 lt http www accessdata fda gov scripts cdrh cfdocs cfcfr cfrsearch cfm cfrpart 11 gt Further reading EditTaylor K T 2006 The status of electronic laboratory notebooks for chemistry and biology Current Opinion in Drug Discovery amp Development 9 3 348 353 PMID 16729731 Rubacha M Rattan A K Hosselet S C 2011 A Review of Electronic Laboratory Notebooks Available in the Market Today Journal of Laboratory Automation 16 1 90 98 doi 10 1016 j jala 2009 01 002 PMID 21609689 Retrieved from https en wikipedia org w index php title Electronic lab notebook amp oldid 1136406450, wikipedia, wiki, book, books, library,

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