Difference between revisions of "User:Shawndouglas/sandbox/sublevel5"
Shawndouglas (talk | contribs) |
Shawndouglas (talk | contribs) |
||
Line 19: | Line 19: | ||
To be sure, a LIMS is an investment for any sized laboratory, whether it's almost exclusively monetary (with some other organization doing a majority of the heavy lifting, as with a [[Cloud computing|cloud-based]] solution) or some combination of monetary and in-house resource expenditure (as with a self-hosted solution located on-premises, whether that solution is a commercial proprietary offering or an [[Open-source software|open-source]] offering). Even an open-source LIMS still requires the lab to lean on an employee or third-party consultant to set up, configure, and maintain the software (or even modify the source code), as well as maintain the local IT infrastructure to support it. The open-source route may make sense for small, single labs with a couple of instruments, but the lack of regulatory-driven functionality like an [[audit trail]] in all but a few open-source LIMS (e.g., [[SENAITE]]<ref name="SENAITEFeats">{{cite web |url=https://www.senaite.com/features |title=SENAITE - Features |publisher=SENAITE Foundation |accessdate=13 December 2023}}</ref>) may significantly restrict the available options to such labs. | To be sure, a LIMS is an investment for any sized laboratory, whether it's almost exclusively monetary (with some other organization doing a majority of the heavy lifting, as with a [[Cloud computing|cloud-based]] solution) or some combination of monetary and in-house resource expenditure (as with a self-hosted solution located on-premises, whether that solution is a commercial proprietary offering or an [[Open-source software|open-source]] offering). Even an open-source LIMS still requires the lab to lean on an employee or third-party consultant to set up, configure, and maintain the software (or even modify the source code), as well as maintain the local IT infrastructure to support it. The open-source route may make sense for small, single labs with a couple of instruments, but the lack of regulatory-driven functionality like an [[audit trail]] in all but a few open-source LIMS (e.g., [[SENAITE]]<ref name="SENAITEFeats">{{cite web |url=https://www.senaite.com/features |title=SENAITE - Features |publisher=SENAITE Foundation |accessdate=13 December 2023}}</ref>) may significantly restrict the available options to such labs. | ||
This brings up the point of what a lab typically sacrifices with LIMS alternatives such as paper notebooks, spreadsheets, and ERP solutions. These alternatives rarely address: | This brings up the point of what a lab typically sacrifices with LIMS alternatives such as paper notebooks, spreadsheets, and ERP solutions. These alternatives rarely address<ref name="LiscouskiImprov22">{{cite web |url=https://www.lablynx.com/wp-content/uploads/2023/03/Improving-Lab-Systems-From-Paper-to-Spreadsheets-to-LIMS.pdf |format=PDF |title=Improving Lab Systems: From Paper to Spreadsheets to LIMS |author=Liscouski, J. |publisher=LabLynx, Inc. |date=April 2022 |accessdate=13 December 2023}}</ref><ref name="LiscouskiASci23">{{cite web |url=https://www.limswiki.org/index.php/LII:A_Science_Student%27s_Guide_to_Laboratory_Informatics |title=LII:A Science Student's Guide to Laboratory Informatics |author=Liscouski, J. |editor=Douglas, S.E. |work=LIMSwiki.org |date=November 2023 |accessdate=13 December 2023}}</ref><ref>{{Cite book |last=Ferrero, M.S. |date=2007 |editor-last=Weinberg |editor-first=Sandy |title=Good laboratory practice regulations |url=https://books.google.com/books?id=JR5i0Nz5UWEC&pg=PA233 |chapter=Chapter 8: GLP Documentation |series=Drugs and the pharmaceutical sciences |edition=4th ed |publisher=Informa Healthcare |place=New York |pages=223–240 |isbn=9780849375842}}</ref><ref>{{Cite journal |last=AlTarawneh |first=Ghada |last2=Thorne |first2=Simon |date=2017 |title=A Pilot Study Exploring Spreadsheet Risk in Scientific Research |url=https://arxiv.org/abs/1703.09785 |journal=arXiv |doi=10.48550/ARXIV.1703.09785}}</ref><ref name="McDowallAreSpr20">{{cite journal |url=https://www.chromatographyonline.com/view/are-spreadsheets-a-fast-track-to-regulatory-non-compliance |title=Are Spreadsheets a Fast Track to Regulatory Non-Compliance? |author=McDowall, R.D. |journal=LCGC Europe |volume=33 |issue=9 |pages=468–76 |year=2020 |accessdate=13 December 2023}}</ref><ref>{{Cite journal |last=Ma |first=Ming-Wei |last2=Gao |first2=Xian-Shu |last3=Zhang |first3=Ze-Yu |last4=Shang |first4=Shi-Yu |last5=Jin |first5=Ling |last6=Liu |first6=Pei-Lin |last7=Lv |first7=Feng |last8=Ni |first8=Wei |last9=Han |first9=Yu-Chen |last10=Zong |first10=Hui |date=2023-11-06 |title=Extracting laboratory test information from paper-based reports |url=https://bmcmedinformdecismak.biomedcentral.com/articles/10.1186/s12911-023-02346-6 |journal=BMC Medical Informatics and Decision Making |language=en |volume=23 |issue=1 |pages=251 |doi=10.1186/s12911-023-02346-6 |issn=1472-6947 |pmc=PMC10629084 |pmid=37932733}}</ref>: | ||
*regulatory need for ensuring analytical results haven't been maliciously or accidentally modified (such as with audit trails that clearly and properly maintain the metadata surrounding an inputted analytical or some other value, as well as any changes made to it) | |||
*regulatory need for clearly and accurately indicating a wide variety of metadata about a given sample or analysis | |||
*regulatory need for software tools like spreadsheets to be validated | |||
*regulatory and internal need for data integrity beyond what audit trails provide | |||
*regulatory and internal need for maintaining, archiving, and disposing of data and information for a designated period of time, whether it's paper or electronic | |||
*regulatory and internal need for recorded values to be treated uniformly for all lab operations, using the same units, rounding rules, formulas, limits, etc. | |||
*regulatory and internal need for security of proprietary lab data and information, including methods, analytical values, and associated reports | |||
*internal need for accurate and timely analytical results that have been officially validated/approved (with that validation/approval getting properly documented) | |||
*internal need for timely retrievable of data and information to more readily support decision-making and audits | |||
*internal needs for more than one user to access, add, and modify lab data and information | |||
*internal needs for more timely recording of analytical values from instruments | |||
*internal needs later on to convert paper-based data and information into structured, readable, and importable electronic formats | |||
Revision as of 21:01, 13 December 2023
This is sublevel5 of my sandbox, where I play with features and test MediaWiki code. If you wish to leave a comment for me, please see my discussion page instead. |
Sandbox begins below
[[File:|right|300px]] Title: What are the alternatives to a laboratory information management system (LIMS)?
Author for citation: Shawn E. Douglas
License for content: Creative Commons Attribution-ShareAlike 4.0 International
Publication date: December 2023
Introduction
To be sure, a LIMS is an investment for any sized laboratory, whether it's almost exclusively monetary (with some other organization doing a majority of the heavy lifting, as with a cloud-based solution) or some combination of monetary and in-house resource expenditure (as with a self-hosted solution located on-premises, whether that solution is a commercial proprietary offering or an open-source offering). Even an open-source LIMS still requires the lab to lean on an employee or third-party consultant to set up, configure, and maintain the software (or even modify the source code), as well as maintain the local IT infrastructure to support it. The open-source route may make sense for small, single labs with a couple of instruments, but the lack of regulatory-driven functionality like an audit trail in all but a few open-source LIMS (e.g., SENAITE[1]) may significantly restrict the available options to such labs.
This brings up the point of what a lab typically sacrifices with LIMS alternatives such as paper notebooks, spreadsheets, and ERP solutions. These alternatives rarely address[2][3][4][5][6][7]:
- regulatory need for ensuring analytical results haven't been maliciously or accidentally modified (such as with audit trails that clearly and properly maintain the metadata surrounding an inputted analytical or some other value, as well as any changes made to it)
- regulatory need for clearly and accurately indicating a wide variety of metadata about a given sample or analysis
- regulatory need for software tools like spreadsheets to be validated
- regulatory and internal need for data integrity beyond what audit trails provide
- regulatory and internal need for maintaining, archiving, and disposing of data and information for a designated period of time, whether it's paper or electronic
- regulatory and internal need for recorded values to be treated uniformly for all lab operations, using the same units, rounding rules, formulas, limits, etc.
- regulatory and internal need for security of proprietary lab data and information, including methods, analytical values, and associated reports
- internal need for accurate and timely analytical results that have been officially validated/approved (with that validation/approval getting properly documented)
- internal need for timely retrievable of data and information to more readily support decision-making and audits
- internal needs for more than one user to access, add, and modify lab data and information
- internal needs for more timely recording of analytical values from instruments
- internal needs later on to convert paper-based data and information into structured, readable, and importable electronic formats
Conclusion
References
- ↑ "SENAITE - Features". SENAITE Foundation. https://www.senaite.com/features. Retrieved 13 December 2023.
- ↑ Liscouski, J. (April 2022). "Improving Lab Systems: From Paper to Spreadsheets to LIMS" (PDF). LabLynx, Inc.. https://www.lablynx.com/wp-content/uploads/2023/03/Improving-Lab-Systems-From-Paper-to-Spreadsheets-to-LIMS.pdf. Retrieved 13 December 2023.
- ↑ Liscouski, J. (November 2023). "LII:A Science Student's Guide to Laboratory Informatics". In Douglas, S.E.. LIMSwiki.org. https://www.limswiki.org/index.php/LII:A_Science_Student%27s_Guide_to_Laboratory_Informatics. Retrieved 13 December 2023.
- ↑ Ferrero, M.S. (2007). "Chapter 8: GLP Documentation". In Weinberg, Sandy. Good laboratory practice regulations. Drugs and the pharmaceutical sciences (4th ed ed.). New York: Informa Healthcare. pp. 223–240. ISBN 9780849375842. https://books.google.com/books?id=JR5i0Nz5UWEC&pg=PA233.
- ↑ AlTarawneh, Ghada; Thorne, Simon (2017). "A Pilot Study Exploring Spreadsheet Risk in Scientific Research". arXiv. doi:10.48550/ARXIV.1703.09785. https://arxiv.org/abs/1703.09785.
- ↑ McDowall, R.D. (2020). "Are Spreadsheets a Fast Track to Regulatory Non-Compliance?". LCGC Europe 33 (9): 468–76. https://www.chromatographyonline.com/view/are-spreadsheets-a-fast-track-to-regulatory-non-compliance. Retrieved 13 December 2023.
- ↑ Ma, Ming-Wei; Gao, Xian-Shu; Zhang, Ze-Yu; Shang, Shi-Yu; Jin, Ling; Liu, Pei-Lin; Lv, Feng; Ni, Wei et al. (6 November 2023). "Extracting laboratory test information from paper-based reports" (in en). BMC Medical Informatics and Decision Making 23 (1): 251. doi:10.1186/s12911-023-02346-6. ISSN 1472-6947. PMC PMC10629084. PMID 37932733. https://bmcmedinformdecismak.biomedcentral.com/articles/10.1186/s12911-023-02346-6.