https://www.limswiki.org/api.php?action=feedcontributions&user=99.183.171.198&feedformat=atomLIMSWiki - User contributions [en]2024-03-29T13:22:39ZUser contributionsMediaWiki 1.36.1https://www.limswiki.org/index.php?title=Laboratory_information_management_system&diff=857Laboratory information management system2011-05-06T23:25:23Z<p>99.183.171.198: Added link to LIS; corrected links in Standards section.</p>
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<div>[[File:Icos Laboratories.JPG|thumb|right|Laboratories around the world depend on a LIMS to manage data, assign rights, manage [[Inventory|inventory]], and more.]]<br />
Sometimes referred to as a [[laboratory information system]] (LIS) or laboratory management system (LMS)<ref>{{cite web|title=2011 LIMS Buyers Guide: Introduction|url=http://files.limstitute.com/share/lbgonline/introduction.htm|publisher=Laboratory Informatics Institute, Inc.|accessdate=2011-04-25}}</ref>, a '''laboratory information management system''' (LIMS) is a software-based [[laboratory]] and information management system that offers a set of key features that support a modern laboratory's operations. Those key features include — but are not limited to — [[Workflow|workflow]] and data tracking support, flexible architecture, and smart data exchange interfaces, which fully "support its use in regulated environments."<ref>{{cite web|title=2011 Laboratory Information Management: So what is a LIMS?|url=http://sapiosciences.blogspot.com/2010/07/so-what-is-lims.html|publisher=Sapio Sciences|accessdate=2011-04-25}}</ref> The features and uses of a LIMS have evolved over the years from simple [[sample]] tracking to an [[Enterprise resource planning|enterprise resource planning]] tool that manages multiple aspects of [[Laboratory informatics|laboratory informatics]].<ref>{{cite web|last=Vaughan|first=Alan|title=LIMS: The Laboratory ERP|url=http://www.limsfinder.com/BlogDetail.aspx?id=30648_0_29_0_C|publisher=LIMSfinder.com|accessdate=2011-04-25}}</ref><br />
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Due to the rapid pace at which laboratories and their data management needs shift, the definition of LIMS has become somewhat controversial. As the needs of the modern laboratory vary widely from lab to lab, what is needed from a laboratory information management system also shifts. The end result is the definition of a LIMS will shift based on who you ask and what their vision of the modern lab is.<ref>{{cite web|title=2011 Laboratory Information Management: So what is a LIMS?|url=http://sapiosciences.blogspot.com/2010/07/so-what-is-lims.html|publisher=Sapio Sciences|accessdate=2011-04-25}}</ref> Dr. Alan McLelland of the Institute of Biochemistry, Royal Infirmary, Glasgow highlighted this problem in the late 1990s by explaining how a LIMS is perceived by an analyst, a laboratory manager, an information systems manager, and an accountant, "all of them correct, but each of them limited by the users' own perceptions."<ref>McLelland, Alan (1998). [http://www.rsc.org/pdf/andiv/tech.pdf "What is a LIMS - a laboratory toy, or a critical IT component?"], pp. 1.</ref><br />
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Historically the LIMS, LIS, and [[Process development execution system|process development execution system]] (PDES) have all performed similar functions. A LIMS has generally targeted environmental, research, or commercial analysis, such as pharmaceutical or petrochemical work, whereas the term "LIS" has tended to be used to reference lab informatics systems in the forensics and clinical markets, which often required special case management tools. The distinction between a LIS and LIMS has blurred in recent times, however, as most LIMS now fully support comprehensive case-centric data.<ref>{{cite web|title=2011 LIMS Buyers Guide: How Do I Find the Right LIMS?|url=http://files.limstitute.com/share/lbgonline/how_do_i_find_the_right_lims.htm|publisher=Laboratory Informatics Institute, Inc.||page=3|accessdate=2011-04-25}}</ref> The PDES normally addresses a wider scope, including, for example, [[Virtual manufacturing|virtual manufacturing]] techniques, while not necessarily integrating with [[laboratory equipment]].<br />
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More recently, LIMS products have been expanding even farther beyond their original purpose of sample management. [[Assay]] data management, [[data mining]], data analysis, and [[Electronic laboratory notebook|electronic laboratory notebook]] (ELN) integration are all features that have been added to many LIMS<ref>{{cite web|title=2011 LIMS Buyers Guide: How Do I Find the Right LIMS?|url=http://files.limstitute.com/share/lbgonline/how_do_i_find_the_right_lims.htm|publisher=Laboratory Informatics Institute, Inc.||page=1–4|accessdate=2011-04-25}}</ref>, enabling the realization of translational medicine completely within a single software solution.<br />
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==History of LIMS==<br />
<br />
Up until the late 1970s, the management of laboratory samples and the associated analysis and reporting were time-consuming manual processes often riddled with transcription errors. This gave some organizations impetus to streamline the collection of data and how it was reported. Custom in-house solutions were developed by a few individual laboratories, while some enterprising entities at the same time sought to develop a more commercial reporting solution in the form of special instrument-based systems.<ref name="LIMSHistory">{{cite journal|journal=Laboratory Automation and Information Management|year=1996|volume=32|issue=1|pages=1–5|title=A brief history of LIMS|author=Gibbon, G.A.|doi:10.1016/1381-141X(95)00024-K|url=http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6TH3-3VJRS4M-1&_user=10&_coverDate=05%2F31%2F1996&_rdoc=2&_fmt=high&_orig=browse&_origin=browse&_zone=rslt_list_item&_srch=doc-info(%23toc%235271%231996%23999679998%2349189%23FLP%23display%23Volume)&_cdi=5271&_sort=d&_docanchor=&_ct=30&_acct=C000050221&_version=1&_urlVersion=0&_userid=10&md5=f1570c2b4a71b1ea7fa0477673837b49&searchtype=a|format=PDF|accessdate=2011-04-26}}</ref><br />
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In 1982 the first generation of LIMS was introduced in the form of a single centralized minicomputer, which offered laboratories the first opportunity to utilize automated reporting tools. As the interest in these early LIMS grew, industry leaders like Gerst Gibbon of the Federal Energy Technology Centre in Pittsburgh began planting the seeds of LIMS-related conferences. By 1988 the second-generation commercial offerings were tapping into [[Relational database|relational databases]] to expand LIMS into more application-specific territory, and International LIMS Conferences were in full swing. As personal computers became more powerful and prominent, a third generation of LIMS emerged in the early 1990s. These new LIMS took advantage of the developing client/server architecture, allowing laboratories to implement better data processing and exchanges.<ref name="LIMSHistory" /><br />
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By 1995 the client/server tools had developed to the point of allowing processing of data anywhere on the network. Web-enabled LIMS were introduced the following year, enabling researchers to extend operations outside the confines of the laboratory. From 1996 to 2002 additional functionality was included in LIMS, from wireless networking capabilities and [[Georeference|georeferencing]] of samples, to the adoption of [[XML]] standards and the development of Internet purchasing.<ref name="LIMSHistory" /><br />
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==Technology==<br />
===Laboratory information management operations===<br />
====Sample management====<br />
[[File:Lab worker with blood samples.jpg|thumb|right|A lab worker matches blood samples to documents. With a LIMS, this sort of sample management is made more efficient.]]<br />
The core function of LIMS has traditionally been the management of samples.<ref name="LIMSHistory" /> This typically is initiated when a sample is received in the laboratory, at which point the sample will be registered in the LIMS. This registration process may involve [[accessioning]] the sample and producing [[Barcode|barcodes]] to affix to the sample container. Various other parameters such as clinical or [[Phenotype|phenotypic]] information corresponding with the sample are also often recorded. The LIMS then tracks chain of custody as well as sample location. Location tracking usually involves assigning the sample to a particular freezer location, often down to the granular level of shelf, rack, box, row, and column. Other event tracking such as freeze and thaw cycles that a sample undergoes in the laboratory may be required.<br />
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Modern LIMS have implemented extensive configurability as each laboratory's needs for tracking additional data points can vary widely. LIMS vendors cannot typically make assumptions about what these data tracking needs are, and therefore vendors must create LIMS that are adaptable to individual environments. LIMS users may also have regulatory concerns to comply with such as [[CLIA]], [[HIPAA]], [[GLP]], and FDA specifications, affecting certain aspects of sample management in a LIMS solution.<ref>{{cite web|url=http://www.designworldonline.com/articles/251/4/Regulatory-compliance-drives-LIMS.aspx |title=Regulatory compliance drives LIMS |publisher=Design World |date=2007-02-21 |accessdate=2011-04-26}}</ref> One key to compliance with many of these standards is audit logging of all changes to LIMS data, and in some cases a full [[electronic signature]] system is required for rigorous tracking of field-level changes to LIMS data.<br />
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====Instrument and application integration====<br />
Modern LIMS offer an increasing amount of integration with laboratory instruments and applications. A LIMS may create control files that are "fed" into the instrument and direct its operation on some physical item such as a sample tube or sample plate. The LIMS may then import instrument results files to extract data for quality control assessment of the operation on the sample. Access to the instrument data can sometimes be regulated based on chain of custody assignments or other security features if need be.<br />
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A relatively new development in LIMS products is the ability to import and manage raw assay data results.{{Citation needed|date=April 2011}} Modern targeted assays such as qPCR and deep sequencing can produce tens of thousands of data points per sample. Furthermore, in the case of drug and diagnostic development as many as 12 or more assays may be run for each sample. In order to track this data, a LIMS solution needs to be adaptable to many different assay formats at both the data layer and import creation layer, while maintaining a high level of overall performance. Some LIMS products address this by simply attaching assay data as [[Binary large object|BLOB]]s to samples, but this limits the utility of that data in data mining and downstream analysis.<br />
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====Electronic data exchange====<br />
The exponentially growing volume of data created in laboratories coupled with increased business demands and focus on profitability have pushed LIMS vendors to increase attention to how their LIMS handles electronic data exchanges. Attention must be paid to how an instrument's input and output data is managed, how remote <br />
sample collection data is imported and exported, and how PDAs and tablet technology integrates with the LIMS. The successful transfer of data files in Microsoft Excel and other formats, as well as the import and export of data to Oracle, SQL, and Microsoft Access databases is a pivotal aspect of a the modern LIMS.<ref>{{cite web|title=2011 LIMS Buyers Guide: How Do I Find the Right LIMS?|url=http://files.limstitute.com/share/lbgonline/how_do_i_find_the_right_lims.htm|publisher=Laboratory Informatics Institute, Inc.||page=2|accessdate=2011-04-25}}</ref> In fact, the transition "from proprietary databases to standardized database management systems such as Oracle ... and SQL" has arguably had one of the biggest impacts on how data is managed and exchanged in laboratories.<ref>Wood, Simon (2007). [http://www.starlims.com/AL-Wood-Reprint-9-07.pdf "Comprehensive Laboratory Informatics: A Multilayer Approach"], pp. 1.</ref><br />
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====Additional functions====<br />
Aside from the key functions of sample management, instrument and application integration, and electronic data exchange, there are numerous additional operations that can be managed in a LIMS. This includes but is not limited to<ref>{{cite web|last=Vaughan|first=Alan|title=LIMS: The Laboratory ERP|url=http://www.limsfinder.com/BlogDetail.aspx?id=30648_0_29_0_C|publisher=LIMSfinder.com|accessdate=2011-04-25}}</ref><ref>{{cite web|title=2011 LIMS Buyers Guide: How Do I Find the Right LIMS?|url=http://files.limstitute.com/share/lbgonline/how_do_i_find_the_right_lims.htm|publisher=Laboratory Informatics Institute, Inc.||page=1–4|accessdate=2011-04-25}}</ref><ref>{{cite web|title=ASTM E1578 - 06 Standard Guide for Laboratory Information Management Systems (LIMS)|url=http://www.astm.org/Standards/E1578.htm|publisher=ASTM International|accessdate=2011-04-25}}</ref>:<br />
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; [[Audit|audit]] management<br />
: fully track and maintain an audit trail<br />
; [[Barcode|barcode]] handling<br />
: assign one or more data points to a barcode format; read and extract information from a barcode<br />
; chain of custody<br />
: assign roles and groups that dictate access to specific data records and who is managing them<br />
; compliance<br />
: follow regulatory standards that affect the laboratory<br />
; customer relationship management<br />
: handle the demographic information and communications for associated clients<br />
; document management<br />
: process and convert data to certain formats; manage how documents are distributed and accessed<br />
; instrument [[Calibration|calibration]] and maintenance<br />
: schedule important maintenance and calibration of lab instruments and keep detailed records of such activities<br />
; inventory and equipment management<br />
: measure and record inventories of vital supplies and laboratory equipment<br />
; manual and electronic data entry<br />
: provide fast and reliable interfaces for data to be entered by a human or electronic component<br />
; method management<br />
: provide one location for all laboratory process and procedure (P&P) and methodology to be housed and managed<br />
; personnel and workload management<br />
: organize work schedules, workload assignments, employee demographic information, and financial information<br />
; quality assurance and control<br />
: guage and control sample quality, data entry standards, and workflow; reports<br />
: create and schedule reports in a specific format; schedule and distribute reports to designated parties<br />
; time tracking<br />
: claculate and maintain processing and handling times on chemical reactions, workflows, and more<br />
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===Client-side LIMS options===<br />
A LIMS can use many delivery technologies. Thin-client LIMS implementations — including Java-based solutions — often require no special [[Client-side|client-side]] installation resulting in less IT involvement in their deployment. An exception is a web-based solution based on [[.NET Framework|.NET]] technologies, requiring a special plug-in on the client and may be limited to Microsoft only browsers. This can lead to issues in instances where there is a high penetration of Apple and Linux usage by lab technicians or researchers. Another concern regarding web-based and web-enabled deployment is possible exploitation by hackers where highly sensitive laboratory and research data may be compromised. Even with modern security methods in place, deploying a LIMS solution "outside the firewall" of an organization opens the LIMS to potential intrusion.<br />
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''The following represent the four most-used LIMS architectures, and their associated strengths and weaknesses:''<br />
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====Thick-client====<br />
A thick-client LIMS is a more traditional client/server architecture, with some of the system residing on the computer or workstation of the user (the client) and the rest on the server. The LIMS software is installed on the client computer, which does all of the data processing. Later it passes information to the server, which has the primary purpose of data storage. Most changes, upgrades, and other modifications will happen on the client side. This was one of the first architectures implemented into a LIMS, having the advantage of providing higher processing speeds (because processing is done on the client and not the server) and slightly more security (as access to the server data is limited only to those with client software). Additionally, thick-client systems have the added advantage of providing more interactivity and customization, though often at a greater learning curve. The disadvantages of client-side LIMS include the need for more robust client computers and more time-consuming upgrades, as well as a lack of base functionality through a web browser. The thick-client LIMS can become web-enabled through an add-on component.<ref name="SciComp">{{cite web|author=O'Leary, Keith M.|title=Selecting the Right LIMS: Critiquing technological strengths and limitations|url=http://www.scimag.com/Selecting-the-Right-LIMS.aspx|publisher=Scientific Computing|accessdate=2011-04-26}}</ref><ref name="LabVantage">LabVantage Solutions, Inc. (2011). [http://www.labvantage.com/resources/pdf/whitepapers/ThinClient1101JY21CYL.pdf "How Differences in Technology Affect LIMS Functionality, Cost, & ROI"], pp. 2–3.</ref><br />
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====Thin-client====<br />
A thin-client LIMS is a more modern architecture which offers full application functionality accessed through a device's web browser. The actual LIMS software resides on a server (host) which feeds and processes information without saving it to the user's hard disk. Any necessary changes, upgrades, and other modifications are handled by the entity hosting the server-side LIMS software, meaning all end-users see all changes made. To this end, a true thin-client LIMS will leave no "footprint" on the client's computer, and only the integrity of the web browser need be maintained by the user. The advantages of this system include significantly lower cost of ownership and fewer network and client-side maintenance expenses. However, this architecture has the disadvantage of requiring real-time server access, a need for increased network throughput, and slightly less functionality. A sort of hybrid architecture that incorporates the features of thin-client browser usage with a thick client exists in the form of a web-based LIMS.<ref name="SciComp" /><ref name="LabVantage" /><br />
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Some LIMS vendors are beginning to rent hosted, thin-client solutions as "[[Software as a service|software as a service]]" (SaaS). These solutions tend to be less configurable than on premise solutions and are therefore considered for less demanding implementations such as laboratories with few users and limited sample processing volumes. <br />
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Another implementation of the thin client architecture that's offered is the maintenance, warranty, and support (MSW) agreement. Pricing levels are typically based on a percentage of the license fee, with a standard level of service for 10 concurrent users being approximately 10 hours of supports and additional customer service at $200 per hour.<ref>{{cite web|title=2011 LIMS Buyers Guide: How Do I Find the Right LIMS?|url=http://files.limstitute.com/share/lbgonline/how_do_i_find_the_right_lims.htm|publisher=Laboratory Informatics Institute, Inc.||page=4|accessdate=2011-04-25}}</ref> Though some may choose to opt out of an MSW after the first year, it's often more economical to continue the plan in order to receive updates to the LIMS, giving it a longer life span in the laboratory.<br />
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====Web-enabled====<br />
A web-enables LIMS architecture is essentially a thick-client architecture with an added web browser component. In this setup, the client-side software has additional functionality that allows users to interface with the software through their device's browser. This functionality is typically limited only to certain functions of the web client. The primary advantage of a web-enabled LIMS is the end-user can access data both on the client side and the server side of the configuration. As in a thick-client architecture, updates in the software must be propagated to every client machine. However, the added disadvantages of requiring always-on access to the host server and the need for cross-platform functionality mean that additional overhead costs may arise.<ref name="SciComp" /><ref name="LabVantage" /><br />
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====Web-based====<br />
Arguably one of the most confusing architectures, web-based LIMS architecture is a hybrid of the thick- and thin-client architectures. While much of the client-side work is done through a web browser, the LIMS also requires the additional support of Microsoft's .NET Framework technology installed on the client device. The end result is a process that is apparent to the end-user through the Microrosoft-compatible web browser, but perhaps not so apparent as it runs thick-client-like processing in the background. In this case, web-based architecture has the advantage of providing more functionality through a more friendly web interface. The disadvantages of this setup are more sunk costs in system administration and support for Internet Explorer and .NET technologies, and reduced functionality on PDAs and tablets.<ref name="SciComp" /><ref name="LabVantage" /><br />
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=== LIMS configurability ===<br />
LIMS implementations are notorious for often being lengthy and costly. This is due in part to the diversity of requirements within each lab, but also to the inflexible nature of LIMS products for adapting to these widely varying requirements. Newer LIMS solutions are beginning to emerge that take advantage of modern techniques in software design that are inherently more configurable and adaptable — particularly at the data layer — than prior solutions. This means not only that implementations are much faster, but also that the costs are lower and the risk of obsolescence is minimized.<br />
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==Standards covered by LIMS==<br />
A LIMS covers standards such as:<br />
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* [[21 CFR Part 11|Title 21 CFR Part 11]] from the [[Food and Drug Administration]] (United States)<br />
* [[ISO 17025]]<br />
* [[ISO 15189]]<br />
* [[Good laboratory practice]]<br />
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==See also==<br />
*[[Laboratory informatics]]<br />
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== Further reading ==<br />
{{cite journal|journal=Laboratory Automation and Information Management|year=1996|volume=32|issue=1|pages=1–5|title=A brief history of LIMS|author=Gibbon, G.A.|doi:10.1016/1381-141X(95)00024-K|url=http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6TH3-3VJRS4M-1&_user=10&_coverDate=05%2F31%2F1996&_rdoc=2&_fmt=high&_orig=browse&_origin=browse&_zone=rslt_list_item&_srch=doc-info(%23toc%235271%231996%23999679998%2349189%23FLP%23display%23Volume)&_cdi=5271&_sort=d&_docanchor=&_ct=30&_acct=C000050221&_version=1&_urlVersion=0&_userid=10&md5=f1570c2b4a71b1ea7fa0477673837b49&searchtype=a|format=PDF}}<br />
<br />
Wood, Simon (2007). [http://www.starlims.com/AL-Wood-Reprint-9-07.pdf "Comprehensive Laboratory Informatics: A Multilayer Approach"], pp. 1.<br />
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==References==<br />
<references/></div>99.183.171.198https://www.limswiki.org/index.php?title=LIS&diff=856LIS2011-05-06T23:21:39Z<p>99.183.171.198: Created redirect.</p>
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<div>#REDIRECT [[Laboratory information system]]</div>99.183.171.198https://www.limswiki.org/index.php?title=Laboratory_information_system&diff=855Laboratory information system2011-05-06T23:21:04Z<p>99.183.171.198: Created article stub.</p>
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<div>A '''laboratory information system''' (LIS) is a software system that records, manages, and stores data for clinical [[Laboratory|laboratories]]. A LIS has traditionally been most adept at sending laboratory test orders to lab instruments, tracking those orders, and then recording the results, typically to a searchable database.<ref>{{cite web|url=http://www.biohealthmatics.com/technologies/his/lis.aspx|title=Laboratory Information Systems|publisher=Biohealthmatics.com|date=2006-08-10|accessdate=2011-05-06}}</ref> The standard LIS has supported the operations of public health institutions (like hospitals and clinics) and their associated labs by managing and reporting critical data concerning "the status of infection, immunology, and care and treatment status of patients."<ref>{{cite web|url=http://www.aphl.org/aphlprograms/global/.../LISQuickStartGuide.pdf|title=Quick Start Guide to Laboratory Information System (LIS) Implementation|format=PDF|publisher=Association of Public Health Laboratories|accessdate=2011-05-06}}</ref><br />
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== Differences between a LIS and LIMS ==<br />
<br />
<br />
== References ==<br />
<references /></div>99.183.171.198https://www.limswiki.org/index.php?title=Chromatography_data_system&diff=839Chromatography data system2011-05-06T02:34:56Z<p>99.183.171.198: Corrected link error in reference.</p>
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<div>Sometimes referred to as a '''chromatography data system''' (CDS), a '''chromatography data management system''' (CDMS) is a set of dedicated data-collection tools that interface and/or integrate with a laboratory's [[Chromatography|chromatography]] equipment.<br />
<br />
<br />
== History of the CDMS ==<br />
<br />
The first attempts to automate the analysis of chromatography data through electronics took place in the early 1970s. These analysis tools utilized microprocessor-based integrators, "dedicated devices for measuring chromatographic<br />
peaks and performing user-specified calculations" which also featured a printer plotter to output the results. <ref name="CDSI">McDowall, R.D. (1999). [http://www.21cfrpart11.com/files/library/compliance/cds_1.pdf "Chromatography Data Systems I: The Fundamentals"] (PDF), pp. 1-2.</ref> Limited memory plagued those early systems, preventing more than one chromatograph from being stored at any one time. This became less of problem for large labs with bigger budgets in the mid-70s, as expensive centralized data systems were installed, allowing greater data storage and sharing capabilities.<ref name="CDSI" /> <br />
<br />
As computers shrank in size, the personal computer became a viable reality. In 1980 entrepreneur and Hewlett-Packard prodigy Dave Nelson saw the potential the personal computer could have on the field of analytical chemistry, joining with partner Harmon Brown to create Nelson Analytical Inc. That year they developed the first CDMS personal computer software, soon followed by Turbochrom, the first CDMS system for MS Windows.<ref>{{cite web|title=David Nelson to receive the first annual PITTCON Heritage Award |url=http://scienceblog.com/community/older/2002/G/20021575.html |publisher=Science Blog |date=January 2002 |accessdate=2011-05-05}}</ref><ref>{{cite journal|journal=Today's Chemist at Work |year=2002 |volume=11 |issue=9 |pages=20 |title=CDS: Networked and Regulated |author=Felton, Michael J. |format=PDF |url=http://pubs.acs.org/subscribe/archive/tcaw/11/i09/pdf/902felton.pdf}}</ref><br />
<br />
== References ==<br />
<references/><br />
<br />
== Further reading ==</div>99.183.171.198https://www.limswiki.org/index.php?title=Chromatography_data_system&diff=838Chromatography data system2011-05-06T02:32:55Z<p>99.183.171.198: /* History of the CDMS */</p>
<hr />
<div>Sometimes referred to as a '''chromatography data system''' (CDS), a '''chromatography data management system''' (CDMS) is a set of dedicated data-collection tools that interface and/or integrate with a laboratory's [[Chromatography|chromatography]] equipment.<br />
<br />
<br />
== History of the CDMS ==<br />
<br />
The first attempts to automate the analysis of chromatography data through electronics took place in the early 1970s. These analysis tools utilized microprocessor-based integrators, "dedicated devices for measuring chromatographic<br />
peaks and performing user-specified calculations" which also featured a printer plotter to output the results. <ref name="CDSI">McDowall, R.D. (1999). [http://www.21cfrpart11.com/files/library/compliance/cds_1.pdf "Chromatography Data Systems I: The Fundamentals"] (PDF), pp. 1-2.</ref> Limited memory plagued those early systems, preventing more than one chromatograph from being stored at any one time. This became less of problem for large labs with bigger budgets in the mid-70s, as expensive centralized data systems were installed, allowing greater data storage and sharing capabilities.<ref name="CDSI" /> <br />
<br />
As computers shrank in size, the personal computer became a viable reality. In 1980 entrepreneur and Hewlett-Packard prodigy Dave Nelson saw the potential the personal computer could have on the field of analytical chemistry, joining with partner Harmon Brown to create Nelson Analytical Inc. That year they developed the first CDMS personal computer software, soon followed by Turbochrom, the first CDMS system for MS Windows.<ref>{{cite web|title=David Nelson to receive the first annual PITTCON Heritage Award |url=http://scienceblog.com/community/older/2002/G/20021575.html |publisher=Science Blog |date=January 2002 |accessdate=2011-05-05}}</ref><ref>{{cite journal|journal=Today's Chemist at Work |year=2002 |volume=11 |issue=9 |pages=20 |title=CDS: Networked and Regulated |author=Felton, Michael J. |format=PDF |url=pubs.acs.org/subscribe/archive/tcaw/11/i09/pdf/902felton.pdf}}</ref><br />
<br />
== References ==<br />
<references/><br />
<br />
== Further reading ==</div>99.183.171.198https://www.limswiki.org/index.php?title=Chromatography_data_system&diff=837Chromatography data system2011-05-06T02:31:29Z<p>99.183.171.198: Added content to history.</p>
<hr />
<div>Sometimes referred to as a '''chromatography data system''' (CDS), a '''chromatography data management system''' (CDMS) is a set of dedicated data-collection tools that interface and/or integrate with a laboratory's [[Chromatography|chromatography]] equipment.<br />
<br />
<br />
== History of the CDMS ==<br />
<br />
The first attempts to automate the analysis of chromatography data through electronics took place in the early 1970s. These analysis tools utilized microprocessor-based integrators, "dedicated devices for measuring chromatographic<br />
peaks and performing user-specified calculations" which also featured a printer plotter to output the results. <ref name="CDSI">McDowall, R.D. (1999). [http://www.21cfrpart11.com/files/library/compliance/cds_1.pdf "Chromatography Data Systems I: The Fundamentals"] (PDF), pp. 1-2.</ref> Limited memory plagued those early systems, preventing more than one chromatograph from being stored at any one time. This became less of problem for large labs with bigger budgets in the mid-70s, as expensive centralized data systems were installed, allowing greater data storage and sharing capabilities.<ref name="CDSI" /> <br />
<br />
As computers shrank in size, the personal computer became a viable reality. In 1980 entrepreneur and Hewlett-Packard prodigy Dave Nelson saw the potential the personal computer could have on the field of analytical chemistry, joining with partner Harmon Brown to create Nelson Analytical Inc. That year they developed the first CDMS personal computer software, soon followed by Turbochrom, the first CDMS system for MS Windows.<ref>{{cite web|title=David Nelson to receive the first annual PITTCON Heritage Award |url=http://scienceblog.com/community/older/2002/G/20021575.html |publisher=Science Blog |date=January 2002 |accessdate=2011-05-05}}</ref><ref>{{cite journal|journal=Today's Chemist at Work|year=2002|volume=11|issue=9|pages=20|title=CDS: Networked and Regulated |author=Felton, Michael J.|format=PDF|url=pubs.acs.org/subscribe/archive/tcaw/11/i09/pdf/902felton.pdf}}</ref><br />
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== References ==<br />
<references/><br />
<br />
== Further reading ==</div>99.183.171.198https://www.limswiki.org/index.php?title=Enterprise_content_management&diff=802Enterprise content management2011-05-05T01:51:58Z<p>99.183.171.198: Added note about ECM as an enterprise content manager.</p>
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<div>In respect to [[Laboratory informatics|laboratory informatics]], the process of enterprise content management (ECM; also sometimes referred to as an enterprise content ''manager'') and its associated tools present, organize, and maintain the documents (SOPs, [[RFP]]s, proposals, etc.) most important to the function of a laboratory as a business entity.<br />
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[[Category:Documentation]]</div>99.183.171.198https://www.limswiki.org/index.php?title=Electronic_laboratory_notebook&diff=761Electronic laboratory notebook2011-05-03T23:55:08Z<p>99.183.171.198: Created article divisions and started section on history.</p>
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<div>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.<br />
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Electronic lab notebooks are a fairly new technology and offer many benefits to the user as well as organizations. For example electronic lab notebooks are easier to search upon, support collaboration amongst many users, and can be made more secure than their paper counterparts.<br />
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ELNs can be divided into two categories:<br />
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* "Specific ELNs" contain features designed to work with specific applications, scientific instrumentation or data types.<br />
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* "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.<br />
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==History of the ELN==<br />
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Significant discussion concerning the transition from a pen-and-paper laboratory notebook to an electronic format were 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><br />
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==Regulations and Legal Aspects==<br />
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. <br />
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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.) and 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) 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. <br />
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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.).<br />
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==Modern features of an ELN==<br />
A good electronic laboratory notebook should offer both 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.<br />
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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 should be stored in a database (eg. MySQL, MS-SQL, Oracle) and therefore be fully searchable. The system should enable data to be collected, stored and retrieved through any combination of forms and/or ELN that best meets the requirements of the user.<br />
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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 QC'd and are not expired, and that workers are trained and authorized to use the equipment and perform the procedures.<br />
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== References ==<br />
<references /></div>99.183.171.198https://www.limswiki.org/index.php?title=Template:Cite_web&diff=760Template:Cite web2011-05-03T23:54:33Z<p>99.183.171.198: </p>
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