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==Sandbox begins below==
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{{Infobox company
| style   = width: 500px;
|company_name     = '''LabLynx, Inc.'''
| text      = This article is a sandbox article. This is a work in progress and not a completed article for the encyclopedic wiki mainspace.
|company_logo      =  [[File:LLX_Current_Logo_277.jpg]]
|company_type      =  Incorporated
|traded_as        =
|industry          =  [[Laboratory informatics]]
|genre            =
|fate              =
|predecessor      =
|successor        =
|company_slogan   =
|foundation        =  July 24, 2000<ref name="SoS_llx">{{cite web |url=http://corp.sos.state.ga.us/corp/soskb/Corp.asp?33586 |title=Business Entity – LabLynx, Inc. |publisher=Georgia Secretary of State |accessdate=22 October 2011}}</ref>
|founder          =  [[LabLynx KB:John H. Jones|John H. Jones]]
|defunct          =
|location_city    =  2400 Lake Park Drive<br>Smyrna, Georgia
|location_country  =  U.S.
|locations        = 
|area_served      =  Worldwide
|key_people        = 
|products          =  {{Collapsible list
  |framestyle=border:none; padding:0;
  |title=<small>Products list</small>
  |1=<li>ELab
  |2=<li>Health Cloud Hub
  |3=<li>LiMStudio
  |4=<li>webLIMS}}
|production        =
|service          =
|revenue          = 
|operating_income  = 
|net_income        = 
|aum              =
|assets            = 
|equity            =
|owner            = 
|num_employees    =  15<ref name="Manta" />
|parent            = 
|divisions        =
|subsid            = 
|homepage          =  {{URL|http://www.lablynx.com/|LabLynx.com}}
|footnotes        =
|intl              =  No
}}
}}
'''LabLynx, Inc.''' is a privately owned, funded, and managed American corporation that develops, supports, and markets [[laboratory information management system]] (LIMS) solutions. Its most well-known products include ELab, a browser-based LIMS, and webLIMS, which is ELab offered in a scalable, hosted "[[software as a service]]" (SaaS) delivery model. The company’s primary clients include [[Laboratory|laboratories]] in the agriculture, clinical, environmental, [[Forensic science|forensics]], health care, and manufacturing industries, including government agencies.<ref>{{cite web|title=Internet Software and Services – LabLynx, Inc. |url=http://investing.businessweek.com/research/stocks/private/snapshot.asp?privcapId=40482985|publisher=Bloomberg Businessweek |accessdate=22 October 2011}}</ref> The company is known for introducing one of the first browser-based LIMS products in 1997<ref name="LS_prod">{{cite web |url=http://www.limsource.com/products/vatlanta.html |archiveurl=http://web.archive.org/web/20071012123126/http://www.limsource.com/products/vatlanta.html |archivedate=12 October 2007 |title=LIMSource: LIMS Vendor: LabLynx, Inc. |accessdate=22 October 2011}}</ref><ref name="LIMSwb" /> and being a long-term player in the [[laboratory informatics]] market. It’s estimated that LabLynx employs fifteen people.<ref name="Manta">{{cite web|title=LabLynx, Inc. - Atlanta, Georgia (GA) |url=http://www.manta.com/c/mmj7tyc/lablynx-inc |publisher=Manta Media, Inc. |accessdate=31 October 2011}}</ref>


==History==
==LIMS functionality requirements specific to cannabis testing==
The average general-purpose [[laboratory information management system]] (LIMS) will have a wide array of functionality. However, such a LIMS developed with [[Quality control|quality]] in mind will take into account additional factors, such as the requirements that current [[RefWork:Known cannabis testing regulations in the United States|regulatory schemes]], industry standards, and organizational guidelines place on the development of a LIMS. This development can and should be framed with a strong [[Specification (technical standard)|specification]] based on those regulations, standards, and guidelines, a specification such as [[limswiki:Book:LIMSpec 2019 R1|LIMSpec]]. Such a specification ideally addresses system requirements involving aspects including but not limited to sample management, reporting, resource management, quality control, system and instrument integration, data integrity, and cybersecurity.


Before LabLynx was a company, it was a LIMS product offered by Atlanta Systems Consultants, Inc. (ASC).<ref name="LLX_archive1">{{cite web |url= http://www.lablynx.com/ |archiveurl=http://web.archive.org/web/19990125100717/http://www.lablynx.com/ |archivedate=25 January 1998 |title=LABLynx On The Web |accessdate=22 October 2011}}</ref><ref name="doh_fl">{{cite web|title=LABlynx on the Web |url=http://www.doh.state.fl.us/Irm/Apps/ihis/JADS/deh/Market%20Research/Background/asc_website.pdf |publisher=Florida Department of Health |date=8 March 2000 |accessdate=22 October 2011}}</ref> Formed in 1992,<ref name="SoS_asc">{{cite web|title=Business Entity – Atlanta Systems Consultants, Inc. |url=http://corp.sos.state.ga.us/corp/soskb/Corp.asp?863137|publisher=Georgia Secretary of State|accessdate=22 October 2011}}</ref> ASC’s LabLynx division later began work on a laboratory information management system designed specifically for a web browser. ASC demonstrated its new Internet Explorer-based LabLynx LIMS at [[Pittsburgh Conference on Analytical Chemistry and Applied Spectroscopy|Pittcon]] in 1997, among the first browser-based LIMS to appear at the time.<ref name="LS_prod"/><ref name="LIMSwb">{{cite book|title=LIMS Workbook - A Practical Guide |edition=3rd |author=McGinnis, Mike and Norman Perkins|chapter=I. Wireless LANs |year=2003 |pages=I-16 |publisher=Q2marketsite, Inc. |asin=B00161Y71K}}</ref> The company again showcased LabLynx at Pittcon in 1998<ref name="LS_pitt98">{{cite web |url=http://www.limsource.com/calendar/pitt98.html |archiveurl=http://web.archive.org/web/19980529121944/http://www.limsource.com/calendar/pitt98.html |archivedate=29 May 1998 |title=LIMSource: Calendar: Pittcon ’98 Preview |accessdate=22 October 2011}}</ref> and soon after picked up a major LIMS-based contract with the U.S. Customs Service.<ref name="FBO">{{cite web|title=70 -- Laboratory Information Management Software (LIMS) (07/30/98) |url=http://www.fbodaily.com/cbd/archive/1998/07(July)/30-Jul-1998/70awd003.htm|publisher=FedBizOpps|accessdate=22 October 2011}}</ref>
But what about the special requirements of a [[cannabis]] testing [[laboratory]]? How does a specification document like LIMSpec—and by extension, a LIMS—address those laboratory needs?


<div class="col-md-3 pull-right">
The following examines the special requirements of cannabis testing and how a LIMS can address them. In particular, those requirements are matched to existing requirements in the original base [[limswiki:Book:LIMSpec 2019 R1|LIMSpec]] specification document. (Note: You'll see slightly modified text of these same LIMSpec items in the following chapters.) Additional background is also provided. In a few rare cases, a LIMSpec requirement may not have a specific regulation, standard, or guidance document matched to it. These represent areas where regulatory bodies and standards agencies may need to address a gap in the future.
<div class="thumbnail img-thumbnail">http://upload.wikimedia.org/wikipedia/commons/c/c2/2400_Lake_Park_Drive%2C_Smyrna%2C_Georgia.jpg This is a caption</div>
</div>
 
By July 2000, the LabLynx division of ASC separated to become its own incorporated entity.<ref name="SoS_llx" /> And while ASC eventually ceased to exist in 2005,<ref name="SoS_asc" /> LabLynx, Inc. went on to diversify its offerings. LabLynx’s browser-based LIMS previously demonstrated at Pittcon in 1997 expanded to become ELab, which in 2001 took on an application service provider (ASP) model of distribution.<ref name="LS_prod2">{{cite web |url=http://www.limsource.com/products/vatlanta.html |archiveurl= http://web.archive.org/web/20010409200118/http://www.limsource.com/products/vatlanta.html |archivedate=9 April 2001 |title=LIMSource: LIMS Vendor: Atlanta Systems Consultants, Inc. |accessdate=22 October 2011}}</ref> In 2004 LabLynx released a browser-based tool called openLIMS, which gave consultants and end-users the ability "to build custom LIMS solutions that are geared to the exact operational needs of many different laboratories."<ref>{{cite web|title=Build your own LIMS: News from LabLynx |url=http://www.laboratorytalk.com/news/lbl/lbl100.html |publisher=LaboratoryTalk.com |date=6 January 2004 |accessdate=22 October 2011}}</ref>
 
On June 19, 2006, LabLynx established the Laboratory Informatics Institute, an open membership group with the purpose of advancing the field of laboratory informatics and shaping the standards associated with it.<ref name="LII">{{cite web|title=Laboratory Informatics Institute Established |url=http://www.limsfinder.com/BlogDetail.aspx?id=31049_0_3_0_C |publisher=Laboratory Informatics Institute, Inc. |date=17 July 2006 |accessdate=22 October 2011}}</ref> LabLynx made further moves to better its LIMS offerings in August 2008, renewing and expanding its contract with Nagarro, Inc., a U.S.-based technology consulting firm. The collaboration allowed LabLynx to upgrade its existing LIMS software to .NET architecture and expand its initiative to create and market a SaaS-based LIMS.<ref name="Nagarro1">{{cite web|title=LABLynx Extends Contract with Nagarro to Include Additional Product Development and SaaS Projects |url=http://www.nagarro.com/NewsEvents/Press%20Releases/LABLynx%20Extends%20Contract%20with.aspx |publisher=Nagarro, Inc. |date=20 August 2008 |accessdate=22 October 2011}}</ref> Less than a year after the announced renewed partnership, LabLynx revealed its redeveloped webLIMS product to the public, featuring ELab in a SaaS model and additional integration of developer tools to allow users to create and modify modules for the LIMS.<ref name="webLIMS1">{{cite web|title=LabLynx launches the new webLiMS.com, Laboratory SaaS Provider |url=http://scienceandresearch.argylenews.com/press_release.aspx?LabLynx-launches-the-new-webLiMScom-Laboratory-SaaS-Provider-542 |publisher=Argyle News |date=6 March 2009 |accessdate=22 October 2011}}</ref><ref name="webLIMS2">{{cite web|title=Weblims – LabLynx |url=http://www.scientific-computing.com/products/product_details.php?product_id=544 |publisher=Scientific Computing World |date=6 March 2009 |accessdate=22 October 2011}}</ref> This move to a cloud-based SaaS model brought renewed interest in the company’s LIMS, with clients like the Georgia Department of Agriculture<ref name="ChemEng1">{{cite web|url=http://pubs.acs.org/cen/coverstory/88/8821cover.html |title=LIMS In The Cloud |author=Mullin, Rick |publisher=Chemical & Engineering News |date=24 May 2010 |accessdate=22 October 2011}}</ref> and Cypress Bioscience<ref>{{cite web|url=http://www.lifescienceleader.com/index.php?option=com_jambozine&layout=article&view=page&aid=4056 |title=SaaS Model Turns LIMS Paradigm On Its Head |author=Dubin, Cindy |publisher=Life Science Leader |date=June 2010 |accessdate=22 October 2011}}</ref><ref>{{cite web|title=SaaS - Is a web hosted LIMS right for your laboratory? |url=http://www.lablynx.com/ArticlesBlogs/tabid/326/articleType/ArticleView/articleId/13/SaaS--Is-a-web-hosted-LIMS-right-for-your-laboratory.aspx |publisher=LabLynx, Inc. |date=15 August 2009 |accessdate=22 October 2011}}</ref> taking on the new LIMS.
 
In 2011, LabLynx was involved in an initiative to standardize and structure the transmission of laboratory data that first originates in a LIMS or LIS and then moves to a person's or population of people's [[electronic health record]]s.<ref>{{cite book|title=Laboratory Results Interface (LRI) Pilots Guide |edition= v0.9.4.093011 |author=Clarke, Ann | year=2011 |pages=1–2 |publisher=LabLynx/mdDigest |url= http://wiki.siframework.org/file/view/LRI_Pilots_Guide_Draft_v0_9_4_093011.docx}}</ref> This laboratory results interface (LRI) pilot began in August 2011 and included collaborations with the supported open source project mdDigest and the U.S. Office of the National Coordinator for Health Information Technology (ONC).<ref>{{cite web|title=PROJECT BRIEF: LabLynx/mdDigest Pilot |url=http://wiki.siframework.org/LabLynx+Pilot+Brief |publisher= LabLynx/mdDigest |accessdate=22 October 2011}}</ref>
<!-- Hiding info about HCH as it was put on hold
In July 2014, LabLynx introduced Health Cloud Hub, a conglomeration of hardware and cloud-based healthcare applications, including a [[laboratory information system]] (LIS) and an [[electronic health record]].<ref name="HCHArch">{{cite web |url=http://www.healthcloudhub.com/ |archiveurl=https://web.archive.org/web/20140717163536/http://www.healthcloudhub.com/ |title=Health Cloud Hub |publisher=LabLynx, Inc |archivedate=17 July 2014 |accessdate=17 July 2014}}</ref>
// -->
===Community history===
 
Since transitioning from Atlanta Systems Consultants, Inc. to LabLynx, Inc. in 2000, LabLynx has become increasingly active in the laboratory informatics community. Projects that LabLynx has started or been involved in within the community include:
 
* the Laboratory Informatics Institute, an open trade association with the mission of educating, standardizing, and promoting the laboratory informatics industry<ref name="LII" />
* LIMSfinder, an online interactive magazine released by the Laboratory Informatics Institute that aims to be "the best resource for information technology in the laboratory"<ref>{{cite web|title=LIMSfinder Home |url=http://www.limsfinder.com/Home.aspx |publisher=Laboratory Informatics Institute, Inc.|accessdate=22 October 2011}}</ref>
* LIMSbook, a LIMS buyer’s guide released by the Laboratory Informatics Institute<ref>{{cite web|title=The LIMS Book |url=http://limsbook.com/ |publisher=Laboratory Informatics Institute, Inc.|accessdate=22 October 2011}}</ref>
* LIMSforum, a LinkedIn discussion group created to facilitate the exchange of ideas and technical information across the fields of laboratory, science, and [[health informatics]]<ref>{{cite web|title=Lablynx - latest company news |url=http://www.laboratorytalk.com/news/lbl/lbl103.html |publisher=LaboratoryTalk.com |date=25 August 2009 |accessdate=22 October 2011}}</ref><ref>{{cite web|title=LiMS forum - Laboratory Informatics Institute user's group for LIMS, Scientific & Health Informatics |url=http://www.linkedin.com/groups?about=&gid=2069898 |publisher=LinkedIn.com |accessdate=22 October 2011}}</ref>
* LIMSuniversity, an open-access learning resource released by the Laboratory Informatics Institute, targeted towards laboratories and the LIMS community<ref>{{cite web|title=LiMSuniversity.com, the on-line, Open Access, Virtual Learning Center for Laboratory Informatics users and professionals |url=http://www.limsfinder.com/BlogDetail.aspx?id=35134_0_25_0_C |publisher=Laboratory Informatics Institute, Inc. |date=4 April 2011 |accessdate=22 October 2011}}</ref>
* LIMSwiki, a Creative Commons-licensed wiki with the goal of bringing related informatics communities together to maintain a repository of information about the industry<ref>{{cite web|title=LIMSwiki mission |url=http://limswiki.org/index.php/LIMSwiki_mission |date=2 June 2011 |accessdate=22 October 2011}}</ref>
 
==Technology and products==
 
LabLynx develops, supports, and markets several products for the laboratory, science, and health industries:
 
===ELab===
 
ELab is a laboratory information management system (LIMS) and collection of associated modules developed to help professionals in the scientific community manage data coming into and leaving the laboratory.<ref name="ELab1">{{cite web|title=ELab LIMS |url=http://lablynx.com/Products/ELabLIMS/tabid/240/Default.aspx |accessdate=22 October 2011}}</ref> The original LabLynx LIMS became known as ELab shortly before LabLynx fully separated from Atlanta Systems Consultants, Inc. in 2001.<ref name="LS_prod2" />
 
Over 30 different modules and functions are included with ELab, and licenses for the software are available with both onsite of offsite hosting services. LabLynx also states that ELab currently serves in many validated environments, including [[21 CFR Part 11]], College of American Pathologists (CAP), and [[ISO/IEC 17025]], in compliance with such standards as [[Health Insurance Portability and Accountability Act|HIPAA]], [[Health Level 7|HL7]], STORENET, [[Food and Drug Administration|FDA]]- and [[United States Environmental Protection Agency|EPA]]-regulated [[good laboratory practice]] (GLP), and more.<ref name="ELab1" />
 
===webLIMS===
 
webLIMS is a hosted [[software as a service]] (SaaS) version of the ELab LIMS.<ref name=webAbout>{{cite web_short|url=http://www.lablynx.com/Products/webLiMScom/tabid/237/Default.aspx |title=webLIMS |publisher=LabLynx, Inc. |accessdate=03 February 2012}}</ref> LabLynx introduced the offering in March 2009, touting 35 different laboratory informatics and business applications in the hosted package.<ref name="webLIMS1" /> As with most SaaS software, LabLynx intends to reduce cost to laboratories, decrease the amount of downtime, and provide a more scalable LIMS solution with its webLIMS service.<ref name="ChemEng1" /><ref name="webAbout" />
 
LabLynx claims the facility it uses for hosting the webLIMS application is an "SAS70 Type II audited, ultra-safe and fully redundant [[data center]]."<ref name="webLIMS1" /> To prevent downtime due to power outages, LabLynx states that its data center has:
 
* parallel independent supply lines and facility circuits
* instant battery backup and transition to multiple parallel diesel turbine generators
* hardware powered by two separate feeds and a Tripp Lite instant power distribution switch to the alternative feed<ref>{{cite web|title=The webLiMS.com Data Center Facilities |url=http://lablynx.com/AboutUs/DataCenter/Facilities/tabid/248/Default.aspx |publisher=LabLynx, Inc. |accessdate=22 October 2011}}</ref>
 
====Product Features====
''To show the contents of the following section, click the "Expand" link to the right. To later hide the contents for easier reading, click the "Collapse" link.''
 
<div class="mw-collapsible mw-collapsed" style="width:100%; background-color:white;">
<p>&nbsp;</p>
The following product features are listed for eLab and webLIMS, as found on the [http://www.lablynx.com/Products/ELabLIMS/tabid/240/Default.aspx LabLynx site]. For more about the features of LabLynx products, consult the feature table below.
 
1. '''Sample login, [[Accessioning (medical)|accessioning]],  etc.'''
 
• Link documents, tests, processes, and paths to match your workflow.
   
   
• Create scheduled events.
===Sample registration===
 
'''Cannabis testing LIMS requirement''': The system should provide sample registration screens optimized for the cannabis testing industry, including the ability to differentiate among [[Cannabis (drug)|medical marijuana]], recreational marijuana, and [[hemp]], as well as derivative products and their various substrates.
• Create variations for cases, projects/lots, and sample points.
 
• Create sample and result batches.
 
2. '''Barcoding'''
 
• Generate barcode labels and schedule the generation of them.
 
• Track inventory, samples, etc.
 
3. '''Mobile  device integration and support'''
 
4. '''Workload management'''
 
• Designate responsibility for any samples, batches or other items based on location, qualification, or other criteria.
 
• View analyst's assignments
 
5. '''Workflow management'''
 
• Set an unlimited number of processes.
 
• Assign specific processes to a specific sample.
 
6. '''Scheduling'''


• Define regular intervals for anything, including sample/batch receipt, instrument calibration and maintenance, training courses, and shelf life.
'''Relevant LIMSpec''':
* 1.11 The system should support the creation of user-definable default sample registration input screens and/or preferences.


• Schedule holidays and time off.
'''Additional background''': Even though some LIMS already provide the ability for users to define their own sample registration screens and fields, it doesn't necessarily mean the vendor will also include pre-loaded screens and preferences for a specific industry or scientific discipline. Those vendors tailoring sample registration screens and preferences specifically to cannabis testing lab requirements for launch-day deployment have a step up on other LIMS vendors. Also, sample registration should also support both remote sampling and in-lab sampling activities.


7. '''Sample analysis and results entry'''


• Assign sample tests and paths.
===Pre-loaded cannabis testing protocols, labels, and analytical reports===
'''Cannabis testing LIMS requirement''': The system should offer pre-loaded compliant cannabis testing protocols, labels, and analytical reports that are optimized to and readily adjustable for a rapidly changing industry.


• Enter results manually or imports them directly from instruments.  
'''Relevant LIMSpec''':
* 1.2 The system should allow for creation and use of pre-configured (e.g., for basic clinical samples) and customizable (e.g., for regulated activities such as blood collection and storage) sample labels, with barcode support.
* 1.6 The system shall allow for the addition, modification, and removal of new, pre-defined, and custom analytical tests.
* 4.1 The system shall allow for the verification of specification limits for accuracy or tolerances while indicating to the user when values are exceeded.
* 6.5 The system shall substantiate the status of verified results by using tools like a certificate of analysis, which shall include details like unique identifiers; analysis procedures used; reference intervals; environmental conditions; who provided the results; additional comments, opinions, and interpretations and who provided them; and applicable times and dates.
* 6.6 The system shall allow a certificate of analysis to be generated upon the verification and approval of results and associated metadata by authorized personnel.
* 6.7 The system shall provide the ability to clearly and accurately generate reports for a variety of standard situations, including certificates of analysis from testing, pending samples for approval, out-of-specification samples and tests, instruments pending calibration, expired reagents to be disposed, and trend charts of laboratory performance.
* 6.8 The system should, in addition to standard reports, provide the means for custom automatic and manual reporting, including but not limited to sample registration reports, work and backlog lists, laboratory performance reports, instrument reports, statistical analysis reports, regulatory reports, incident reports, chain of custody reports, quality assurance reports, service reports, inventory analysis reports, and investigator/sponsor reports.


• View, report, analyze, organize, and export results.
'''Additional background''': As with sample registration, end users of a cannabis testing LIMS will appreciate having a wide array of pre-loaded testing protocols, label templates, and report templates. This includes the ability to customize analytical reports such as [[Certificate of analysis|certificates of analysis]] (COAs) for multiple testing scenarios like batch testing and batch-by-batch variance analysis.


• Supports all character types.


• Enter comments or attach images.
===Creation and management of additional protocols, labels, and analytical reports===
'''Cannabis testing LIMS requirement''': The system should provide users the tools for creating new, compliant test protocols, labels, and reports, as well as managing them as the industry changes.


8. '''QA/QC'''
'''Relevant LIMSpec''':
* 1.2 The system should allow for creation and use of pre-configured (e.g., for basic clinical samples) and customizable (e.g., for regulated activities such as blood collection and storage) sample labels, with barcode support.
* 1.6 The system shall allow for the addition, modification, and removal of new, pre-defined, and custom analytical tests.
* 4.1 The system shall allow for the verification of specification limits for accuracy or tolerances while indicating to the user when values are exceeded.
* 6.8 The system should, in addition to standard reports, provide the means for custom automatic and manual reporting, including but not limited to sample registration reports, work and backlog lists, laboratory performance reports, instrument reports, statistical analysis reports, regulatory reports, incident reports, chain of custody reports, quality assurance reports, service reports, inventory analysis reports, and investigator/sponsor reports.
* 32.9 The system shall support configurable laboratory workflows based on appropriate laboratory process and procedure.


• Create templates to apply as desired, or create QC samples on an ad-hoc basis.  
'''Additional background''': As with pre-loaded protocols, labels, and analytical reports, providing users the ability to create and manage their own protocols, labels, and reports—including COAs—as the industry changes is vital. Similarly, the same need for a flexible yet robust means of adjusting limit sets—and preserving older ones—is also required.


• Support for out-of-limit flagging, formulas, and charting/trending.
===Flexible specification limit sets===
'''Cannabis testing LIMS requirement''': The system should support the development and maintenance of flexible and robust limit sets for various state and local regulations, as well as specific substrate testing requirements.


9. '''Instrument interfacing, calibration, and maintenance'''
'''Relevant LIMSpec''':
* 4.1 The system shall allow for the verification of specification limits for accuracy or tolerances while indicating to the user when values are exceeded.
* 32.2 The system shall allow authorized users to configure the specification limits for sample and instrument tests.


• Can interface with any instrument that produces a text file.  
'''Additional background''': A vital component of the previously mentioned testing protocols that should not be overlooked is how flexible their test parameter/specification limit sets are. As regulations and standards concerning cannabis testing—across many different substrates—may change rapidly at the federal, state, and local level, adjustments to the limits declared within testing protocols must be easy to make. Additionally, the system should be capable of retaining older historic limit sets, such that past results can later be accurately linked to their original limit sets.<ref name="LabLynx5.4LIMS">{{cite web |url=https://www.limswiki.org/index.php/LabLynx_KB:SysAdmin_-_5.4_LIMS_system_setup |title=LabLynx KB:SysAdmin - 5.4 LIMS system setup |author=LabLynx, Inc |work=LIMSwiki.org |date=13 October 2011 |accessdate=18 December 2020}}</ref>


• Track maintenance and calibration history, including any uploaded receipts or other documents.


• Store instrument details like model, serial number, date of purchase, assigned tests, authorized analysts, etc.
===Third-party system integration===
'''Cannabis testing LIMS requirement''': The system should provide a means to manually or automatically connect with and securely transfer information between (integrate with) state-required compliance reporting systems, [[seed-to-sale]] systems, and other software systems like enterprise resource management (ERP) solutions.  


10. '''Electronic data exchange'''
'''Relevant LIMSpec''':
* 27.1 The system should be capable of communicating any status changes for samples, lots, instruments, and other dynamic entities to and from external systems.
* 27.6 The system should be able to interface directly with a third-party reporting tool.
* 27.15 The system shall provide a means to integrate and exchange data electronically based on relevant methods, and in such a way so as to ensure accurate and secure data transfer and processing.


• Upload instrument results.
'''Additional background''': Seed-to-sale systems, like METRC, or other types of government-mandated reporting systems may have a web-based user interface (webUI) for manual entry of results data, or they may even support a .csv upload of data. However, manual entry of results can be time consuming and result in a higher likelihood of errors. As such, the more efficient way to report data to those types of systems is through more automated means, connecting your LIMS with a web-based [[application programming interface]] (API), typically provided by the vendor of the seed-to-sale or reporting software. This means the LIMS must either be pre-configured to connect with all the necessary APIs or be equipped to handle connection with any API.


• Integrate with third-party software.


• Electronically report to systems like eLexnet or other government-mandated protocols.
===Instrument integration===
'''Cannabis testing LIMS requirement''': The system should provide robust support for accurately and securely integrating with and collecting data from numerous types of scientific instruments.


11. '''Calculations'''
'''Relevant LIMSpec''':
* 26.1 The system should be able to use an application programming interface or web services to communicate with instrument data systems.
* 26.2 The system should be capable of sending samples and test orders to instrument data systems.
* 26.3 The system should be capable of receiving test results from instrument data systems and verifying those results for completeness and readability.
* 26.4 The system should be capable of generically parsing instrument data to extract important sample details and results.


• Perform numerous calculations, including standard arithmetic, log base 10, exponent, and absolute value.
'''Additional background''': From [[Mass spectrometry|mass spectrometers]] and [[chromatography]] equipment to quantitative [[polymerase chain reaction]] (qPCR) systems and moisture balances, being able to accurately and securely transfer analytical data automatically improves turnaround time and better ensures the accuracy of entered results (versus manual data entry). This is particularly important in the highly regulated industry that is cannabis testing.


• Includes standard QC-type calcs like "% Recovery of QC Spike," etc.


• Results from other tests may be included in calculations.
===Granular chain-of-custody===
'''Cannabis testing LIMS requirement''': The system should provide accurate, automatic chain-of-custody (CoC) tracking, down to a granular location level (e.g., "Storage Room 3, Freezer 1, Shelf 3"), and at every step (including package receipt and sending).


12. '''Sample management and tracking'''
'''Relevant LIMSpec''':
* 1.9 The system shall be able to define the sample collection details for registered samples, including container size and type, number of containers, collection date and time, name of the collector, lot number, storage location, preservation method, collection methods used (standard and nonstandard), safety concerns, and retention period.
* 1.12 The system should allow for the recording of sample delivery details such as deliverer, location, and date and time for a preregistered sample.
* 1.14 The system shall provide a user-friendly means for acknowledging the physical reception of sample material in the laboratory, including date and time of reception.
* 1.18 The system shall have the ability to maintain the chain of custody of every sample, meaning the recording of every single sample distribution step to personnel—including details such as unique identifier, name, location, date, and time—while the sample is in the laboratory’s possession.
* 15.5 The system should provide a means for accurately recording the receipt, issue, distribution, and disposal of materials.


• Track the check-in, check-out, transfer, and disposition of samples and other items through the laboratory.  
'''Additional background''': A nickname for a seed-to-sale system is a "track-and-trace" system, highlighting the importance of always knowing the who, what, where, when, and how much of cannabis materials and related products in the industry life cycle. This concept is often referred to as the "chain-of-custody" of cannabis related material. This chain-of-custody is not limited to received cannabis samples, either; it also includes any subsamples and aliquots generated in the testing laboratory, as well as any disposed materials. As such, it's vital the LIMS be able to accurately document the chain of steps received cannabis materials go through, from reception and retention to delivery and destruction. Without this careful documentation, a cannabis testing lab is open to costly fines or, worst case, having their license suspended.


• Document location, date/time, and identity of the user performing the actions.


13. '''Reporting'''
===Inventory reconciliation===
'''Cannabis testing LIMS requirement''': The system should support inventory reconciliation, including sample weight reconciliation, while limiting data entry errors.


• Use configurable standard or create custom reports using the active reporting tool or database reporting tools.
'''Relevant LIMSpec''':
* 1.13 The system shall assign each sample registered in the system a unique identifier using methodologies such as an ID with an incrementing integer or a user-defined naming format.
* 1.15 The system shall allow for the comparison of received samples to the sampling requirements of the customer or laboratory in order to identify variances from those requirements.
* 2.9 The system should provide a means to manually or automatically track sample inventory amounts and status.
* 4.1 The system shall allow for the verification of specification limits for accuracy or tolerances while indicating to the user when values are exceeded.
* 15.1 The system should be capable of accurately tracking the specific quantities of received and consumed test samples.
* 15.5 The system should provide a means for accurately recording the receipt, issue, distribution, and disposal of materials.


• Print, fax, and e-mail generated reports.
'''Additional background''': Related to the "how much" of chain-of-custody tracking, sample weight reconciliation is an important element of avoiding regulatory violations.<ref name="MoberlyAvoid20">{{cite web |url=https://www.rockymountaincannabisconsulting.com/cannabis-business-blog/2020/5/14/avoid-infractions-top-5-metrc-cultivation-violations |title=Avoid Infractions: Top 5 METRC Cultivation Violations |author=Moberly, R. |work=RMCC Blog |date=14 May 2020 |accessdate=18 December 2020}}</ref> The LIMS should be able to either automatically deduct sample and inventory quantities when consumed as part of a test (including subsamples and aliquots), or it should allow manual entry of such changes with background validation checks or warnings. For example, the system would need to clearly warn the user when attempting to pull more weight from a sample than exists, which would create a negative value. Speaking of which...


• Export to Excel and other formats.


14. '''Trending and control charting'''
===Real-time alerts===
'''Cannabis testing LIMS requirement''': The system should support real-time alerts of out-of-specification (OOS) results, so immediate action can be taken, if required.


• Export data to Excel for charting of trends.
'''Relevant LIMSpec''':
* 3.12 The system should effectively alert users upon entry of out-of-specification test results.
* 16.8 The system should provide a means for configurable workflows to manage OOS and OOT incidents according to an organization’s standard operating procedures.


• Use built-in control charting function
'''Additional background''': As part of maintaining [[quality assurance]] and compliance with regulations and standards, it's important users be warned when something goes awry with data entry and analysis. This is typically controlled through the previously mentioned limit sets associated with pre-loaded and custom test protocols. However, other error checking of automatic and manual calculations, e.g., weight reconciliation, should also be inherently built into the LIMS. However, the checks are not enough; users must clearly and promptly be notified of errors and OOS results (via the limit sets) in order to, for example, identify health risks associated with a tested product and send notification that the product should be pulled from store shelves. Additionally, the requirement for maintaining quality testing outcomes for consumer safety further drives the need for prompt real-time alerts.


15. '''Audit trails'''


• Modifications made to information are stamped with that user’s identification and the system level date and time.  
===Data security and confidentiality===
'''Cannabis testing LIMS requirement''': The system should ensure data security and confidentiality for at-rest and in-transit data.


• Users required to enter a reason for result changes.
'''Relevant LIMSpec''':
* 35.1 The system should use secure communication protocols like SSL/TLS over Secure Hypertext Transfer Protocol with 256 bit encryption.
* 35.2 The system should support database encryption and be capable of recording the encryption status of the data contained within.


• Captures the newly entered result as well as the edited result.  
'''Additional background''': When it comes to cannabis and [[protected health information]] (PHI), dispensaries are the most likely to require careful attention to consumer information.<ref name="FawkesReportCanna20">{{cite web |url=https://www.vpnmentor.com/blog/report-thsuite-breach/ |title=Report: Cannabis Users’ Sensitive Data Exposed in Data Breach |author=Fawkes, G. |work=vpnMentor Blog |date=24 January 2020 |accessdate=20 January 2020}}</ref><ref name="ShaghaghiLeak20">{{cite web |url=https://www.cohnreznick.com/insights/leak-of-30000-cannabis-customer-records-heightens-need-for-effective-data-security |title=Leak of 30,000 cannabis customer records heightens need for effective data security |author=Shaghaghi, S.; Weinstein, I. |work=Insights |publisher=CohnReznick LLP |date=18 February 2020 |accessdate=20 January 2020}}</ref> However, that does not preclude laboratories from making strong efforts to protect sensitive personal data related to clients and their analyses (let alone to protect the lab's own validated methods and documentation). As such, cannabis testing labs should rely on a LIMS that uses industry-standard communication protocols and encryption methods to protect not only the data housed in the LIMS but also data moving in and out of it.


• Audit trail can be full or targeted.


16. '''Chain of custody'''
===Accounting and billing===
'''Cannabis testing LIMS requirement''': The system should provide accounting and billing functionality for not only optimal business operations but also to ensure compliance with any regulations involving monetary transactions for cannabis-related services.


• Support to NELAC/NELAP standards.  
'''Relevant LIMSpec''':
* Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec.


• Chain of custody reports printable on demand.
'''Additional background''': Though not necessarily backed by any regulation or standard, carefully tracking expenditures and payments received related to cannabis activities is vital. This is especially true given that the non-hemp (low-THC) ''Cannabis'' plant is still technically illegal to grow and process in the eyes of U.S. federal law. As such, some business taking in money from cannabis-related activities have had problems with managing the financial aspects of their operations.<ref name="KovaleskiUS14">{{cite web |url=https://www.nytimes.com/2014/02/15/us/us-issues-marijuana-guidelines-for-banks.html |title=U.S. Issues Marijuana Guidelines for Banks |author=Kovaleski, S.F. |work=The New York Times |publisher=The New York Times Corporation |date=14 February 2014 |accessdate=18 December 2020}}</ref><ref name="FinCEN_BSA14">{{cite web |url=https://www.fincen.gov/resources/statutes-regulations/guidance/bsa-expectations-regarding-marijuana-related-businesses |title=BSA Expectations Regarding Marijuana-Related Businesses |author=Financial Crimes Enforcement Network |publisher=U.S. Department of the Treasury |date=14 February 2014 |accessdate=18 December 2020}}</ref><ref name="AngellMoreBanks18">{{cite web |url=https://www.forbes.com/sites/tomangell/2018/06/14/more-banks-working-with-marijuana-businesses-despite-federal-moves/#4d828ed21b1b |title=More Banks Working With Marijuana Businesses, Despite Federal Moves |author=Angell, T. |work=Forbes |publisher=Forbes Media, LLC |date=14 June 2018 |accessdate=18 December 2020}}</ref><ref name="BoomsteinCali19">{{cite web |url=https://www.manatt.com/insights/newsletters/financial-services-law/california-dbo-offers-guidance-on-cannabis-banking |title=California DBO Offers Guidance on Cannabis Banking |author=Boomstein, A.L.; Miller, C.D.; Owen, J.L. |publisher=Manatt, Phelps & Phillips, LLP |date=30 October 2019 |accessdate=18 December 2020}}</ref> Given the remaining uncertainty of cannabis legalization in the U.S., and the natural benefits of managing accounting and billing within the LIMS, it makes sense that a LIMS should be able to accurately track receipts and more, down to the penny.


17. '''Document management'''


• Upload and retrieve documents of any kind.
===Secure web portal===
'''Cannabis testing LIMS requirement''': The system should provide a secure web portal for client results review and test ordering.


• Associate documents with samples, results, personnel, customers, instrument maintenance tracking, etc.
'''Relevant LIMSpec''':
* Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec.


• Versioning is forced where required.
'''Additional background''': Similar to accounting and billing functionality, this requirement for a portal for customer access isn't necessarily mandated by any regulation or standard. However, it remains a useful time-saving and customer service element. Additionally, the "secure" part of this requirement must be emphasized. This ties directly to the prior requirement for data security and confidentiality. Web-based attacks remain some of the most popular cybersecurity attacks, targeting the likes of online customer portals and WordPress sites for credentials and sensitive information.<ref name="TalalevWebsite20">{{cite web |url=https://www.webarxsecurity.com/website-hacking-statistics-2018-february/ |title=Website Hacking Statistics in 2020 |author=Talalev, A. |work=WebARX Blog |date=14 September 2020 |accessdate=18 December 2020}}</ref><ref name="EnsightenTop20">{{cite web |url=https://www.ensighten.com/blog/top-five-cyberattacks-targeting-your-website-in-2020 |title=op Five Cyberattacks Targeting Your Website in 2020 |author=Ensighten |work=Ensighten Blog |date=11 February 2020 |accessdate=18 December 2020}}</ref> A quality LIMS that has already proven strong data security gives confidence in the LIMS vendor's ability to implement a web-based customer portal for order review and test ordering.


18. '''Inventory'''


• Organize and track any defined items in the LIMS, grouping them according to specific criteria.
===ISO/IEC 17025 compliance support===
'''Cannabis testing LIMS requirement''': The system should support a laboratory's [[ISO/IEC 17025]] compliance efforts.


• Track storage, usage, and quantity.
'''Relevant LIMSpec''':
* 1.13 The system shall assign each sample registered in the system a unique identifier using methodologies such as an ID with an incrementing integer or a user-defined naming format.
* 2.8 The system should allow for the accurate identification of a physical sample in the system via barcode or RFID technology.
* 4.4 The system shall provide one or more levels of review, as well as interpretation and documentation of results—whether entered manually or via an automated process—before release.
* 6.5 The system shall substantiate the status of verified results by using tools like a certificate of analysis, which shall include details like unique identifiers; analysis procedures used; reference intervals; environmental conditions; who provided the results; additional comments, opinions, and interpretations and who provided them; and applicable times and dates.
* 6.9 The system shall clearly identify a changed, amended, or re-issued report as being such, and clearly identify any change of information and reason for change in such a report.
* 7.1 The system shall be capable of creating, managing, and securely holding a variety of document types, while also allowing for the review and approval of those documents using version and release controls.
* 7.2 The system shall have the ability to readily provide access to electronic documents such as standard operating procedures, quality manuals, instrument manuals, information exchange agreements, and other applicable documents to designated personnel and officials.
* 7.3 The system shall be able to clearly provide the most current version of a document and archive prior versions.
* 7.5 The system shall allow the creation, approval, rejection, and management of sampling and test methods performed at the laboratory, capturing details about the test method, method reference, specifications, assigned limits, holding times, etc. as required by a reference method or regulation.
* 7.6 The system shall provide a means for recording validation information for modified existing or new in-house test methods, either as a method itself or through some other means. Validation information such as procedures used, specifications, performance characteristics, and results obtained shall be allowed as input.
* 7.7 The system shall maintain training and certification records for personnel and allow the assignment of available training paths and certifications to specific personnel, such that only trained, certified, and experienced personnel are able to perform assigned tasks.
* 8.8 The system shall map available system tasks (such as approved test methods) or sample types (such as select agents and toxins) to available training paths and certifications, such that only trained, certified, and experienced personnel are able to perform assigned tasks.
* 10.7 The system shall allow for the configuration of calibration and maintenance frequency and time frames for—as well as the manual and automatic scheduling of calibration or maintenance of—equipment, instruments, and systems. Available intervals should be include days, weeks, months, and years.
* 10.9 The system shall clearly identify any instrument that is out-of-calibration, beyond its preventative maintenance due date, or under investigation and prevent it from being selected for use.
* 10.10 The system shall be able to show all instances of scheduled calibration, preventative maintenance, and service dates for an instrument.
* 10.11 The system shall be able to link a calibration activity to certified reference material or designated measurement processes.
* 10.13 The system shall be able to uniquely identify each instrument and any associated components and maintain that and other information—such as manufacturer, model number, serial number, and calibration and maintenance history—within the system.
* 10.15 The system shall be capable of chronologically logging details for scheduled and unscheduled calibration and maintenance activities for each instrument, including calibration status, calibration standard, date and time of calibration or maintenance, work performed, who conducted it, and signatures of those verifying the completed activities.
* 16.3 The system shall be able to record instances of identified nonconformance and method deviation, as well as the actions required to restore the process to conformity. In the case of a planned deviation, the system shall require documentation, justification, proof of validation, adjusted reference intervals, and authorization for the deviated process.
* 27.3 The system shall provide a means to choose—based on date and type of data—electronic data and metadata to archive.
* 27.4 The system shall provide a guaranteed means to retrieve and restore archived data and metadata that is readable and accurate.
* 27.11 The system’s data storage tools shall provide data backup and retrieval functions that meet or exceed industry best practices, including producing exact and complete backups that are secure from manipulation and loss.
* 30.9 The system should allow for other types of facility monitoring (such as alarm, light, lock, and door statuses) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored systems and their status changes.
* 30.11 The system should allow for environmental control and monitoring of equipment (such as incubators and freezers) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored equipment and their associated status changes.
* 31.4 The system shall have a mechanism to securely retain data in the system for a specific time period and enable protections that ensure the accurate and ready retrieval of that data throughout the records retention period.
* 32.22 The system shall provide a security interface usable across all modules of the system that secures data and operations and prevents unauthorized access to data and functions.
* 33.4 The system should be well documented by the vendor in comprehensive training material for all aspects of system use, including administration, operation, and troubleshooting.
* 33.5 The system shall be validated initially and periodically, with those validation activities being documented, to ensure the accuracy, consistency, and reliability of system performance and its electronic records.
* 34.7 The vendor shall restrict logical access to database storage components to authorized individuals. If providing a hosted service, the vendor should also restrict physical access to database storage components to authorized individuals. (In the case of an on-site solution, the buyer is responsible for limiting physical access to database storage components to meet 21 CFR Part 11, HIPAA, and CJIS guidelines.)


• Receive alerts when stocks go below a defined level.
'''Additional background''': In the U.S., many states mandate analytical testing of cannabis and its related products. This testing is prescribed as a public health safety measure, to ensure those consuming cannabis and derived products are not adversely affected by any harmful substances picked up during processing stages. By extension the public must place trust in those labs conducting this testing, requiring a high level of quality within the laboratory and how it operates. This quality is better assured through laboratory accreditation checks to standards like ISO/IEC 17025, which provides competence requirements for testing and calibration laboratories. ISO/IEC 17025 requirements are non-trivial, covering many aspects of how the laboratory operates, and chief among those requirements is the need for a quality management system. And maintaining quality requires maintaining traceable documentary evidence of those efforts.<ref name="JonPHowCan20">{{cite web |url=https://www.imsm.com/us/news/how-can-a-cannabis-testing-lab-pass-iso-17025/ |title=How can a cannabis testing lab pass ISO 17025? |author=JonP |work=IMSM News |date=31 July 2020 |accessdate=23 December 2020}}</ref> This includes certificates of analysis, quality manuals, standard operating procedures, calibration and maintenance logs, and much more. Your LIMS should make strong efforts towards helping you maintain that documentary evidence to not only assist with compliance efforts, but also push your lab to maintain high levels of quality for those depending on accurate analyses.


19. '''Training tracking'''


• Track completed courses and certifications for all personnel.
===NELAC, ORELAP, and ELAP compliance support===
'''Cannabis testing LIMS requirement''': The system should support a laboratory's NELAC or ORELAP compliance efforts.


• Receive alerts when additional training is required to maintain certifications.  
'''Cannabis testing LIMS requirement''': The system should support a laboratory's ELAP compliance efforts.


• Upload and manage associated documents.
'''Relevant LIMSpec''':
* NOTE: NELAC's ''Volume 1: Management and Technical Requirements for Laboratories Performing Environmental Analysis'' (2016) is proprietary and could not be obtained. The following LIMSpec items are based off New York's ELAP requirements.
* 2.11 The system shall allow samples and tests to be created and used specifically for capturing data related to unique forms of sampling and testing such as representative sampling, calibration testing, quality control testing, preventative maintenance testing, stability testing, sterility testing, compatibility testing, identity testing, proficiency testing, and service-event-related testing.
* 7.1 The system shall be capable of creating, managing, and securely holding a variety of document types, while also allowing for the review and approval of those documents using version and release controls.
* 7.2 The system shall have the ability to readily provide access to electronic documents such as standard operating procedures, quality manuals, instrument manuals, information exchange agreements, and other applicable documents to designated personnel and officials.
* 7.5 The system shall allow the creation, approval, rejection, and management of sampling and test methods performed at the laboratory, capturing details about the test method, method reference, specifications, assigned limits, holding times, etc. as required by a reference method or regulation.
* 7.6 The system shall provide a means for recording validation information for modified existing or new in-house test methods, either as a method itself or through some other means. Validation information such as procedures used, specifications, performance characteristics, and results obtained shall be allowed as input.
* 7.7 The system shall maintain training and certification records for personnel and allow the assignment of available training paths and certifications to specific personnel, such that only trained, certified, and experienced personnel are able to perform assigned tasks.
* 16.6 The system shall allow for the documentation of and corrective and preventive action towards all types of nonconformance.
* 16.7 The system should track and record incidents and associated corrective actions, allowing authorized personnel to document the effectiveness of the actions, identify insufficient resolutions, and curb repeat occurrences.


20. '''Event-driven alerts'''
'''Additional background''': Though ISO/IEC 17025 remains the major standard to be accredited to, other accreditation requirements exist in the world of cannabis testing. These requirements may be state-based, as with the Oregon Environmental Laboratory Accreditation Program (ORELAP)<ref name="ORELAP">{{cite web |url=https://www.oregon.gov/oha/ph/LaboratoryServices/EnvironmentalLaboratoryAccreditation/Pages/Cannabis-accreditation.aspx |title=Accreditation for Laboratories Testing Cannabis in Oregon |publisher=Oregon Health Authority |accessdate=23 December 2020}}</ref> or New York's Environmental Laboratory Approval Program, Certification Manual Item 180.7 for Medical Marijuana.<ref name="ELAP">{{cite web |url=https://www.wadsworth.org/regulatory/elap |title=Environmental Laboratory Approval Program |publisher=New York State Department of Health Wadsworth Center |accessdate=23 December 2020}}</ref> Others like the non-profit NELAC Institute provide national accreditation thought its National Environmental Laboratory Accreditation Program (NELAP), which ORELAP is largely guided by.<ref name="ORELAP" /> This includes NELAC's<ref name="FLAdmin64E-1.0015">{{cite web |url=https://casetext.com/regulation/florida-administrative-code/department-64-department-of-health/division-64e-division-of-environmental-health/chapter-64e-1-certification-of-environmental-testing-laboratories/section-64e-10015-laboratory-certification-standards |title=Fla. Admin. Code R. 64E-1.0015 |work=CaseText |date=08 December 2020 |accessdate=23 December 2020}}</ref>:


• Create alert definitions which are triggered according to your requirements.  
* EL-V1M1-2016-Rev2.1 Module 1, "Proficiency Testing"
* EL-V1M2-ISO-2016-Rev2.1 Module 2 "Quality Systems General Requirements"
* EL-V1M4-2017-Rev2.2 Module 4, "Quality Systems for Chemical Testing"
* EL-V1M5-2016-Rev2.0 Module 5, "Quality Systems for Microbiological Testing"


• Trigger events such as sending e-mails based on user-defined criteria.
As such, this means covering ground similar to ISO/IEC 17025 regarding quality in the laboratory. To better meet these requirements, a cannabis testing LIMS should assist with the maintenance of documentation such as quality manuals, tracking laboratorians' credentials and experience, documenting corrective and preventative action, and documenting proficiency testing results, among other tasks.<ref name="WadsworthEnviron20">{{cite web |url=https://www.wadsworth.org/sites/default/files/WebDoc/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf |format=PDF |title=Environmental Laboratory Approval Program (ELAP) and Laboratory of Environmental Biology (LEB): Procedure on How to Perform an Initial Demonstration of Capability (iDOC) for Medical Marijuana Microbiology |author=New York State Department of Health – Wadsworth Center |publisher=New York Department of Health |date=03 December 2020 |accessdate=23 December 2020}}</ref>


21. '''Multi-language support'''


• Configure language settings.
===Patient Focused Certification (PFC) compliance support===
'''Cannabis testing LIMS requirement''': The system should support a laboratory's Americans for Safe Access (ASA) Patient Focused Certification (PFC) Program laboratory compliance efforts.


• Configure time zone differences for multinational deployment.
'''Relevant LIMSpec''':
* Unknown; unable to acquire document


22. '''Compliance'''
'''Additional background''': The American Association for Laboratory Accreditation (A2LA) incorporates the ASA's PFC Program into its cannabis testing laboratory accreditation, described in its ''R243 - Specific Requirements - Cannabis Testing Laboratory Accreditation Program'' document.<ref name="A2LACanna20">{{cite web |url=https://www.a2la.org/accreditation/cannabis-testing |title=Cannabis Testing Laboratory Accreditation Program |author=A2LA |accessdate=23 December 2020}}</ref> However, the A2LA will "only give that document to prospective accreditation customers," according to personal communication. As such, it's not clear what those specific PFC requirements are and how they may relate to a LIMS' ability to maintain A2LA's PFC compliance. Presumably those requirements can be better met with a LIMS, whatever the requirements may be. If a vendor indicates their LIMS helps support PFC requirements, it's best to engage in a conversion with the vendor to determine how.
 
• Software complies with [[ASCLD]], [[NELAC]], [[21 CFR Part 11]], [[CLIA]], GALP/GAMP, [[HL7]], [[HIPAA]], Section 508, [[ISO 17025]], [[ASTM]], IEEE, and ACS standards.
 
23. '''Version control'''
 
• Versioning forced on all relevant changes to system data, including tests, parameters, limits, reports, configurations, and software.
 
• All changes are date- and time-stamped
 
24. '''Configurability'''
 
• Most aspects of the system can be configured, including database tables, fields, screens, calculations, reports, charts, external interfaces, tests, parameters, limits.
 
• Define and link processes, tests, and sample or batch paths and all of the associated parameters/limits.
 
• Configure security permissions from micro to macro level on individual screens, tests, processes, job functions, departments, and laboratory locations.
 
25. '''Knowledge management'''
 
• Archive old data for later queries and data mining.
 
• Warehouse results, reports, trends, e-mails, pricing, invoicing, notes, training, and instrument maintenance tracking information.
 
</div>
 
===LiMStudio===
 
LiMStudio is a virtual desktop add-on to LabLynx’s webLIMS hosted application. It consists of a collection of 10 development tools that allow webLIMS users to modify the applications in their account to their own needs. It also allows users the ability to create their own applications to connect to the LIMS, providing a more scalable and customizable LIMS option to clients.<ref>{{cite web|title=LiMStudio.net - Hosted Developer Tools |url=http://lablynx.com/Products/DeveloperTools/tabid/242/Default.aspx |publisher=LabLynx, Inc. |accessdate=22 October 2011}}</ref>
 
<!-- Hiding info about HCH as it was put on hold
===Health Cloud Hub===
 
Health Cloud Hub is a hosted cloud-based platform of both hardware that integrates [[Health Level 7|HL7]] laboratory devices and healthcare software centered around the [[clinical laboratory]]. The base software includes a [[laboratory information system]] and tools for interfacing existing [[electronic health record]] (EHR) and practice management software (PMS). The company states it will also eventually offer hosted EHR and customer relationship management (CRM) applications on the platform.<ref name="HCHArch" /><ref name="LearningCenterHCH">{{cite web |url=http://helpdocs.lablynx.com/LabLynx/default.aspx#pageid=introduction_to_healthcloudhub |title=HealthCloudhub |work=LabLynx Learning Center |publisher=LabLynx, Inc |date=2014 |accessdate=17 July 2014}}</ref>
// -->
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| modular            = Y<ref name="ELabAbout" />
| instrument_inter  = Y<ref name="ELabAbout" />
| mobile_device      = Y<ref name="ELabAbout" />
| alarms_alerts      = Y<ref name="ELabAbout" />
| work_timetrack    = Y<ref name="ELabAbout" />
| voice_rec          = N<ref name="ELabAbout" />
| external_monitor  = Y<ref name="ELabAbout" />
| messaging          = Y<ref name="ELabAbout" />
| multilingual      = Y<ref name="ELabAbout" />
| network            = Y<ref name="ELabAbout" />
| web_client        = Y<ref name="ELabAbout" />
| online_help        = Y<ref name="ELabAbout" />
| saas_model        = Y<ref name="ELabAbout" />
| usage_cost        = Y<ref name="ELabAbout" />
| industries        = agriculture, clinical research, environmental, food and beverage, general, law enforcement and forensic, manufacturing and R&D, pharmaceutical, public health and service
}}
|-
|}
|}
</div>
 
===Pricing===
 
====ELab/webLIMS====
Source for pricing information is via LabLynx.<ref>{{cite web |url=http://2013prices.lablynx.com |format=PDF |title=2013 LIMS Product, Service, Support and Maintenance Price List |publisher=LabLynx, Inc |date=08 November 2013 |accessdate=02 February 2015}}</ref> As prices may change at any time, always contact the vendor directly to obtain a price list or quote.
 
{| class="wikitable collapsible" border="1" cellpadding="5" cellspacing="0"
|-
  ! colspan="5"| LIMS Product Price List
|-
  ! style="color:brown; background-color:#ffffee;"| Part number
  ! style="color:brown; background-color:#ffffee;"| Description
  ! style="color:brown; background-color:#ffffee;"| Number of<br />concurrent users
  ! style="color:brown; background-color:#ffffee;"| Price
  ! style="color:brown; background-color:#ffffee;"| Unit Price
|-
  | '''LLX-ELBS-02'''
  | style="background-color:white;" |ELab SQL Edition for 2 Concurrent Users
  | style="background-color:white;" align="center"|2
  | style="background-color:white;" |$9,500
  | style="background-color:white;" |$4,750
|-
  | '''LLX-ELBS-05'''
  | style="background-color:white;" |ELab SQL Edition for 5 Concurrent Users
  | style="background-color:white;" align="center"|5
  | style="background-color:white;" |$21,500
  | style="background-color:white;" |$4,300
|-
  | '''LLX-ELBS-10'''
  | style="background-color:white;" |ELab SQL Edition for 10 Concurrent Users
  | style="background-color:white;" align="center"|10
  | style="background-color:white;" |$32,000
  | style="background-color:white;" |$3,200
|-
  | '''LLX-ELBS-25'''
  | style="background-color:white;" |ELab SQL Edition for 25 Concurrent Users
  | style="background-color:white;" align="center"|25
  | style="background-color:white;" |$75,000
  | style="background-color:white;" |$3,000
|-
  | '''LLX-ELBS-50'''
  | style="background-color:white;" |ELab SQL Edition for 50 Concurrent Users
  | style="background-color:white;" align="center"|50
  | style="background-color:white;" |$140,000
  | style="background-color:white;" |$2,800
|-
  | '''LLX-ELBS-UL'''
  | style="background-color:white;" |ELab SQL Edition for Unlimited Concurrent Users
  | style="background-color:white;" align="center"|Unlimited
  | style="background-color:white;" |$275,000
  | style="background-color:white;" |
|-
  | '''LLX-ELBO-10'''
  | style="background-color:white;" |ELab Oracle Edition for 10 Concurrent Users
  | style="background-color:white;" align="center"|10
  | style="background-color:white;" |$65,000
  | style="background-color:white;" |$6,500
|-
  | '''LLX-ELBO-25'''
  | style="background-color:white;" |ELab Oracle Edition for 25 Concurrent Users
  | style="background-color:white;" align="center"|25
  | style="background-color:white;" |$150,000
  | style="background-color:white;" |$6,000
|-
  | '''LLX-ELBO-50'''
  | style="background-color:white;" |ELab Oracle Edition for 50 Concurrent Users
  | style="background-color:white;" align="center"|50
  | style="background-color:white;" |$250,000
  | style="background-color:white;" |$5,000
|-
  | '''LLX-ELBO-UL'''
  | style="background-color:white;" |ELab Oracle Edition for Unlimited Concurrent Users
  | style="background-color:white;" align="center"|Unlimited
  | style="background-color:white;" |$475,000
  | style="background-color:white;" |
|-
  | '''LLX-WLM-02'''
  | style="background-color:white;" |webLIMS.com (SaaS) Edition for 2 Concurrent Users<br />(Prices quoted are per month.)
  | style="background-color:white;" align="center"|2
  | style="background-color:white;" |$500
  | style="background-color:white;" |$250
|-
  | '''LLX-WLM-05'''
  | style="background-color:white;" |webLIMS.com (SaaS) Edition for 5 Concurrent Users<br />(Prices quoted are per month.)
  | style="background-color:white;" align="center"|5
  | style="background-color:white;" |$800
  | style="background-color:white;" |$160
|-
  | '''LLX-WLM-10'''
  | style="background-color:white;" |webLIMS.com (SaaS) Edition for 10 Concurrent Users<br />(Prices quoted are per month.)
  | style="background-color:white;" align="center"|10
  | style="background-color:white;" |$1,250
  | style="background-color:white;" |$125
|-
  | '''LLX-WLM-25'''
  | style="background-color:white;" |webLIMS.com (SaaS) Edition for 25 Concurrent Users<br />(Prices quoted are per month.)
  | style="background-color:white;" align="center"|25
  | style="background-color:white;" |$2,500
  | style="background-color:white;" |$100
|-
  | '''LLX-WLM-50'''
  | style="background-color:white;" |webLIMS.com (SaaS) Edition for 50 Concurrent Users<br />(Prices quoted are per month.)
  | style="background-color:white;" align="center"|50
  | style="background-color:white;" |$4,000
  | style="background-color:white;" |$80
|-
  | '''LLX-WLM-UL'''
  | style="background-color:white;" |webLIMS.com (SaaS) Edition for Unlimited Concurrent Users<br />(Prices quoted are per month.)
  | style="background-color:white;" align="center"|Unlimited
  | style="background-color:white;" |$7,500
  | style="background-color:white;" |
|-
|}
 
{| class="wikitable collapsible" border="1" cellpadding="5" cellspacing="0" width="900"
|-
  ! colspan="6"| LIMS Maintenance, Warranty, Support, and Service Plans
|-
  ! style="color:brown; background-color:#ffffee;"| Maintenance and support plans
  ! style="color:brown; background-color:#ffffee;"| Maintenance
  ! style="color:brown; background-color:#ffffee;"| Annual service and support hours incl.
  ! style="color:brown; background-color:#ffffee;"| Support hours
  ! style="color:brown; background-color:#ffffee;"| Maintenance, support, and service costs
  ! style="color:brown; background-color:#ffffee;"| Special notes
|-
  | '''Bronze'''
  | style="background-color:white;" | One year of unlimited updates and upgrades plus warranty
  | style="background-color:white;" align="center"| 4
  | style="background-color:white;" | 8 a.m. to 5 p.m. EST, excluding holidays
  | style="background-color:white;" | 15% of total license fee; minimum $4,500 per year; hourly services and support at $185/hour
  | style="background-color:white;" | This plan is included at no charge to all webLIMS accounts with 1–9 concurrent users.
|-
  | '''Silver'''
  | style="background-color:white;" | One year of unlimited updates and upgrades plus warranty
  | style="background-color:white;" align="center"| 16
  | style="background-color:white;" | 8 a.m. to 5 p.m. EST, excluding holidays
  | style="background-color:white;" | 15% of total license fee; minimum $5,500 per year; hourly services and support at $175/hour
  | style="background-color:white;" | This plan is included at no charge to all webLIMS accounts with 10–24 concurrent users.
|-
  | '''Gold'''
  | style="background-color:white;" | One year of unlimited updates and upgrades plus warranty
  | style="background-color:white;" align="center"| 24
  | style="background-color:white;" | 8 a.m. to 5 p.m. EST, excluding holidays
  | style="background-color:white;" | 15% of total license fee; minimum $8,500 per year; hourly services and support at $165/hour
  | style="background-color:white;" | This plan is included at no charge to all webLIMS accounts with 25–74 concurrent users.
|-
  | '''Platinum'''
  | style="background-color:white;" | One year of unlimited updates and upgrades plus warranty
  | style="background-color:white;" align="center"| 40
  | style="background-color:white;" | 24 hours per day, 7 days per week
  | style="background-color:white;" | 15% of total license fee; minimum $25,000 per year; hourly services and support at $150/hour
  | style="background-color:white;" | This plan is included at no charge to all webLIMS accounts with 75+ concurrent users.
|-
|}
 
===Demonstration videos and other media===
 
The following demonstration videos are available for ELab and webLIMS:
 
* [http://files.mylablynx.com/share/ebooks/movies/p3/Presentation_Files/index.html LabLynx: A Guide to the Company]
* [http://files.mylablynx.com/share/eBooks/Movies/p4/Presentation_Files/index.html LIMS: The Laboratory ERP]
* [http://files.mylablynx.com/share/ebooks/Movies/d100/d100.html LIMS and ISO 17025]
* [http://www.lablynx.com/webcasts/cda/Presentation_Files/index.html The LabLynx ELab LIMS for Agriculture Labs]
* [http://files.mylablynx.com/share/ebooks/movies/d7/d7.html The LabLynx ELab LIMS for Water/Wastewater and Environmental Labs]
* [http://files.mylablynx.com/share/ebooks/movies/p13/Presentation_Files/index.html The LabLynx ELab LIMS for Medical Examiners]
* [http://files.mylablynx.com/share/eBooks/Movies/p2/Presentation_Files/index.html The LabLynx ELab LIMS for Pharmaceutical Labs]
* [http://files.mylablynx.com/share/ebooks/Movies/t4/t4.html ELab - Key Functions and Topics]
* [http://files.mylablynx.com/share/ebooks/Movies/d108/d108.html ELab: FOG Functionality]
* [http://files.mylablynx.com/share/ebooks/movies/d11/d11.html ELab: Sample Login and Receiving in ELab]
* [http://files.mylablynx.com/share/ebooks/movies/d140/d140.html ELab: Sample Receiving – In Depth]
* [http://files.mylablynx.com/share/ebooks/Movies/d102/d102.html ELab: Local and Remote Accessioning]
* [http://files.mylablynx.com/share/ebooks/Movies/d104/d104.html ELab: Data Entry - Manual, Bulk, Importing, and Instrument Interfaces]
* [http://files.mylablynx.com/share/ebooks/Movies/d105/d105.html ELab: External Interfaces, Queries, and Exporting Data]
* [http://files.mylablynx.com/share/ebooks/Movies/d106/d106.html ELab: Case Coordination]
* [http://files.mylablynx.com/share/ebooks/movies/d139/d139.html ELab: Project Receiving]
* [http://files.mylablynx.com/share/eBooks/Movies/d14/d14.html ELab: Benchsheets]
* [http://files.mylablynx.com/share/ebooks/movies/d163/d163.html ELab: Analysis Price Quoting and Invoicing]
* [http://files.mylablynx.com/share/ebooks/Movies/d103/d103.html ELab: Invoicing - Special Pricing, Editing and Tracking Invoices]
* [http://files.mylablynx.com/share/ebooks/movies/d161/d161.html ELab: e-Signatures]
* [http://files.mylablynx.com/share/ebooks/movies/d162/d162.html ELab: Password Management and Session Timeout]
* [http://files.mylablynx.com/share/ebooks/movies/d166/d166.html ELab: Work Assignment and Tracking]
* [http://files.mylablynx.com/share/ebooks/movies/d23/d23.html ELab: Inventory of Stocks, Standards, and Reagents]
* [http://files.mylablynx.com/share/ebooks/movies/d172/d172.html ELab: Creating Storage Locations]
* [http://files.mylablynx.com/share/ebooks/movies/d188/d188.html ELab: Changing Field Captions and Labels]
* [http://files.mylablynx.com/share/eBooks/Movies/d24/d24.html ELab: Instrument Calibration and Maintenance Management]
* [http://files.mylablynx.com/share/ebooks/movies/d26/d26.html ELab: Creating and Editing Custom Reports]
* [http://files.mylablynx.com/share/eBooks/Movies/d31/d31.html ELab: Tracking and Versioning Reports]
* [http://files.mylablynx.com/share/ebooks/movies/d34/d34.html ELab: Security Access Control]
* [http://files.mylablynx.com/share/ebooks/movies/d35/d35.html ELab: Audit Trail]
* [http://files.mylablynx.com/share/eBooks/Movies/d37/d37.html ELab: Results Trending, QC Charting, and Limits Update]
* [http://files.mylablynx.com/share/ebooks/movies/d40/d40.html ELab: Analyte and Test Group Management]
* [http://files.mylablynx.com/share/ebooks/movies/d75/d75.html ELab: Creating and Managing Picklists]
* [http://files.mylablynx.com/share/ebooks/movies/d93/d93.html ELab: System Setup]
* [http://files.mylablynx.com/share/ebooks/movies/d98/d98.html ELab: Training Management and Certification Tracking]
* [http://files.mylablynx.com/share/ebooks/Movies/f1/f1.html ELab: Forensic Case Management]
 
===Additional information===
 
==External links==
* [http://www.lablynx.com/ Official website]
* [http://www.healthcloudhub.com/ Health Cloud Hub website]
* [http://www.limsuniversity.com/ LIMSuniversity site]
* [http://www.limsfinder.com/ LIMSfinder site]
* [http://www.limswiki.org/ LIMSwiki site]
* [http://vimeo.com/lablynx LabLynx on Vimeo]
* [http://www.youtube.com/user/lablynx LabLynx on YouTube]


==References==
==References==
{{Reflist|colwidth=30em}}
{{Reflist|colwidth=30em}}
<!---Place all category tags here-->
[[Category:Agriculture LIMS]]
[[Category:Clinical LIS]]
[[Category:Clinical research LIMS]]
[[Category:Cloud-based LIMS]]
[[Category:Cloud-based LIS]]
[[Category:Environmental LIMS]]
[[Category:Food and beverage LIMS]]
[[Category:General LIMS]]
[[Category:General LIS]]
[[Category:LabLynx KB:Articles]]
[[Category:LabLynx, Inc.]]
[[Category:Law enforcement and forensic LIMS]]
[[Category:LIMS vendor]]
[[Category:Manufacturing and R&D LIMS]]
[[Category:Pharmaceutical LIMS]]
[[Category:Public health and service LIMS]]
[[Category:Veterinary LIS]]
</div>

Latest revision as of 19:10, 30 December 2020

This article is a sandbox article. This is a work in progress and not a completed article for the encyclopedic wiki mainspace.

LIMS functionality requirements specific to cannabis testing

The average general-purpose laboratory information management system (LIMS) will have a wide array of functionality. However, such a LIMS developed with quality in mind will take into account additional factors, such as the requirements that current regulatory schemes, industry standards, and organizational guidelines place on the development of a LIMS. This development can and should be framed with a strong specification based on those regulations, standards, and guidelines, a specification such as LIMSpec. Such a specification ideally addresses system requirements involving aspects including but not limited to sample management, reporting, resource management, quality control, system and instrument integration, data integrity, and cybersecurity.

But what about the special requirements of a cannabis testing laboratory? How does a specification document like LIMSpec—and by extension, a LIMS—address those laboratory needs?

The following examines the special requirements of cannabis testing and how a LIMS can address them. In particular, those requirements are matched to existing requirements in the original base LIMSpec specification document. (Note: You'll see slightly modified text of these same LIMSpec items in the following chapters.) Additional background is also provided. In a few rare cases, a LIMSpec requirement may not have a specific regulation, standard, or guidance document matched to it. These represent areas where regulatory bodies and standards agencies may need to address a gap in the future.

Sample registration

Cannabis testing LIMS requirement: The system should provide sample registration screens optimized for the cannabis testing industry, including the ability to differentiate among medical marijuana, recreational marijuana, and hemp, as well as derivative products and their various substrates.

Relevant LIMSpec:

  • 1.11 The system should support the creation of user-definable default sample registration input screens and/or preferences.

Additional background: Even though some LIMS already provide the ability for users to define their own sample registration screens and fields, it doesn't necessarily mean the vendor will also include pre-loaded screens and preferences for a specific industry or scientific discipline. Those vendors tailoring sample registration screens and preferences specifically to cannabis testing lab requirements for launch-day deployment have a step up on other LIMS vendors. Also, sample registration should also support both remote sampling and in-lab sampling activities.


Pre-loaded cannabis testing protocols, labels, and analytical reports

Cannabis testing LIMS requirement: The system should offer pre-loaded compliant cannabis testing protocols, labels, and analytical reports that are optimized to and readily adjustable for a rapidly changing industry.

Relevant LIMSpec:

  • 1.2 The system should allow for creation and use of pre-configured (e.g., for basic clinical samples) and customizable (e.g., for regulated activities such as blood collection and storage) sample labels, with barcode support.
  • 1.6 The system shall allow for the addition, modification, and removal of new, pre-defined, and custom analytical tests.
  • 4.1 The system shall allow for the verification of specification limits for accuracy or tolerances while indicating to the user when values are exceeded.
  • 6.5 The system shall substantiate the status of verified results by using tools like a certificate of analysis, which shall include details like unique identifiers; analysis procedures used; reference intervals; environmental conditions; who provided the results; additional comments, opinions, and interpretations and who provided them; and applicable times and dates.
  • 6.6 The system shall allow a certificate of analysis to be generated upon the verification and approval of results and associated metadata by authorized personnel.
  • 6.7 The system shall provide the ability to clearly and accurately generate reports for a variety of standard situations, including certificates of analysis from testing, pending samples for approval, out-of-specification samples and tests, instruments pending calibration, expired reagents to be disposed, and trend charts of laboratory performance.
  • 6.8 The system should, in addition to standard reports, provide the means for custom automatic and manual reporting, including but not limited to sample registration reports, work and backlog lists, laboratory performance reports, instrument reports, statistical analysis reports, regulatory reports, incident reports, chain of custody reports, quality assurance reports, service reports, inventory analysis reports, and investigator/sponsor reports.

Additional background: As with sample registration, end users of a cannabis testing LIMS will appreciate having a wide array of pre-loaded testing protocols, label templates, and report templates. This includes the ability to customize analytical reports such as certificates of analysis (COAs) for multiple testing scenarios like batch testing and batch-by-batch variance analysis.


Creation and management of additional protocols, labels, and analytical reports

Cannabis testing LIMS requirement: The system should provide users the tools for creating new, compliant test protocols, labels, and reports, as well as managing them as the industry changes.

Relevant LIMSpec:

  • 1.2 The system should allow for creation and use of pre-configured (e.g., for basic clinical samples) and customizable (e.g., for regulated activities such as blood collection and storage) sample labels, with barcode support.
  • 1.6 The system shall allow for the addition, modification, and removal of new, pre-defined, and custom analytical tests.
  • 4.1 The system shall allow for the verification of specification limits for accuracy or tolerances while indicating to the user when values are exceeded.
  • 6.8 The system should, in addition to standard reports, provide the means for custom automatic and manual reporting, including but not limited to sample registration reports, work and backlog lists, laboratory performance reports, instrument reports, statistical analysis reports, regulatory reports, incident reports, chain of custody reports, quality assurance reports, service reports, inventory analysis reports, and investigator/sponsor reports.
  • 32.9 The system shall support configurable laboratory workflows based on appropriate laboratory process and procedure.

Additional background: As with pre-loaded protocols, labels, and analytical reports, providing users the ability to create and manage their own protocols, labels, and reports—including COAs—as the industry changes is vital. Similarly, the same need for a flexible yet robust means of adjusting limit sets—and preserving older ones—is also required.

Flexible specification limit sets

Cannabis testing LIMS requirement: The system should support the development and maintenance of flexible and robust limit sets for various state and local regulations, as well as specific substrate testing requirements.

Relevant LIMSpec:

  • 4.1 The system shall allow for the verification of specification limits for accuracy or tolerances while indicating to the user when values are exceeded.
  • 32.2 The system shall allow authorized users to configure the specification limits for sample and instrument tests.

Additional background: A vital component of the previously mentioned testing protocols that should not be overlooked is how flexible their test parameter/specification limit sets are. As regulations and standards concerning cannabis testing—across many different substrates—may change rapidly at the federal, state, and local level, adjustments to the limits declared within testing protocols must be easy to make. Additionally, the system should be capable of retaining older historic limit sets, such that past results can later be accurately linked to their original limit sets.[1]


Third-party system integration

Cannabis testing LIMS requirement: The system should provide a means to manually or automatically connect with and securely transfer information between (integrate with) state-required compliance reporting systems, seed-to-sale systems, and other software systems like enterprise resource management (ERP) solutions.

Relevant LIMSpec:

  • 27.1 The system should be capable of communicating any status changes for samples, lots, instruments, and other dynamic entities to and from external systems.
  • 27.6 The system should be able to interface directly with a third-party reporting tool.
  • 27.15 The system shall provide a means to integrate and exchange data electronically based on relevant methods, and in such a way so as to ensure accurate and secure data transfer and processing.

Additional background: Seed-to-sale systems, like METRC, or other types of government-mandated reporting systems may have a web-based user interface (webUI) for manual entry of results data, or they may even support a .csv upload of data. However, manual entry of results can be time consuming and result in a higher likelihood of errors. As such, the more efficient way to report data to those types of systems is through more automated means, connecting your LIMS with a web-based application programming interface (API), typically provided by the vendor of the seed-to-sale or reporting software. This means the LIMS must either be pre-configured to connect with all the necessary APIs or be equipped to handle connection with any API.


Instrument integration

Cannabis testing LIMS requirement: The system should provide robust support for accurately and securely integrating with and collecting data from numerous types of scientific instruments.

Relevant LIMSpec:

  • 26.1 The system should be able to use an application programming interface or web services to communicate with instrument data systems.
  • 26.2 The system should be capable of sending samples and test orders to instrument data systems.
  • 26.3 The system should be capable of receiving test results from instrument data systems and verifying those results for completeness and readability.
  • 26.4 The system should be capable of generically parsing instrument data to extract important sample details and results.

Additional background: From mass spectrometers and chromatography equipment to quantitative polymerase chain reaction (qPCR) systems and moisture balances, being able to accurately and securely transfer analytical data automatically improves turnaround time and better ensures the accuracy of entered results (versus manual data entry). This is particularly important in the highly regulated industry that is cannabis testing.


Granular chain-of-custody

Cannabis testing LIMS requirement: The system should provide accurate, automatic chain-of-custody (CoC) tracking, down to a granular location level (e.g., "Storage Room 3, Freezer 1, Shelf 3"), and at every step (including package receipt and sending).

Relevant LIMSpec:

  • 1.9 The system shall be able to define the sample collection details for registered samples, including container size and type, number of containers, collection date and time, name of the collector, lot number, storage location, preservation method, collection methods used (standard and nonstandard), safety concerns, and retention period.
  • 1.12 The system should allow for the recording of sample delivery details such as deliverer, location, and date and time for a preregistered sample.
  • 1.14 The system shall provide a user-friendly means for acknowledging the physical reception of sample material in the laboratory, including date and time of reception.
  • 1.18 The system shall have the ability to maintain the chain of custody of every sample, meaning the recording of every single sample distribution step to personnel—including details such as unique identifier, name, location, date, and time—while the sample is in the laboratory’s possession.
  • 15.5 The system should provide a means for accurately recording the receipt, issue, distribution, and disposal of materials.

Additional background: A nickname for a seed-to-sale system is a "track-and-trace" system, highlighting the importance of always knowing the who, what, where, when, and how much of cannabis materials and related products in the industry life cycle. This concept is often referred to as the "chain-of-custody" of cannabis related material. This chain-of-custody is not limited to received cannabis samples, either; it also includes any subsamples and aliquots generated in the testing laboratory, as well as any disposed materials. As such, it's vital the LIMS be able to accurately document the chain of steps received cannabis materials go through, from reception and retention to delivery and destruction. Without this careful documentation, a cannabis testing lab is open to costly fines or, worst case, having their license suspended.


Inventory reconciliation

Cannabis testing LIMS requirement: The system should support inventory reconciliation, including sample weight reconciliation, while limiting data entry errors.

Relevant LIMSpec:

  • 1.13 The system shall assign each sample registered in the system a unique identifier using methodologies such as an ID with an incrementing integer or a user-defined naming format.
  • 1.15 The system shall allow for the comparison of received samples to the sampling requirements of the customer or laboratory in order to identify variances from those requirements.
  • 2.9 The system should provide a means to manually or automatically track sample inventory amounts and status.
  • 4.1 The system shall allow for the verification of specification limits for accuracy or tolerances while indicating to the user when values are exceeded.
  • 15.1 The system should be capable of accurately tracking the specific quantities of received and consumed test samples.
  • 15.5 The system should provide a means for accurately recording the receipt, issue, distribution, and disposal of materials.

Additional background: Related to the "how much" of chain-of-custody tracking, sample weight reconciliation is an important element of avoiding regulatory violations.[2] The LIMS should be able to either automatically deduct sample and inventory quantities when consumed as part of a test (including subsamples and aliquots), or it should allow manual entry of such changes with background validation checks or warnings. For example, the system would need to clearly warn the user when attempting to pull more weight from a sample than exists, which would create a negative value. Speaking of which...


Real-time alerts

Cannabis testing LIMS requirement: The system should support real-time alerts of out-of-specification (OOS) results, so immediate action can be taken, if required.

Relevant LIMSpec:

  • 3.12 The system should effectively alert users upon entry of out-of-specification test results.
  • 16.8 The system should provide a means for configurable workflows to manage OOS and OOT incidents according to an organization’s standard operating procedures.

Additional background: As part of maintaining quality assurance and compliance with regulations and standards, it's important users be warned when something goes awry with data entry and analysis. This is typically controlled through the previously mentioned limit sets associated with pre-loaded and custom test protocols. However, other error checking of automatic and manual calculations, e.g., weight reconciliation, should also be inherently built into the LIMS. However, the checks are not enough; users must clearly and promptly be notified of errors and OOS results (via the limit sets) in order to, for example, identify health risks associated with a tested product and send notification that the product should be pulled from store shelves. Additionally, the requirement for maintaining quality testing outcomes for consumer safety further drives the need for prompt real-time alerts.


Data security and confidentiality

Cannabis testing LIMS requirement: The system should ensure data security and confidentiality for at-rest and in-transit data.

Relevant LIMSpec:

  • 35.1 The system should use secure communication protocols like SSL/TLS over Secure Hypertext Transfer Protocol with 256 bit encryption.
  • 35.2 The system should support database encryption and be capable of recording the encryption status of the data contained within.

Additional background: When it comes to cannabis and protected health information (PHI), dispensaries are the most likely to require careful attention to consumer information.[3][4] However, that does not preclude laboratories from making strong efforts to protect sensitive personal data related to clients and their analyses (let alone to protect the lab's own validated methods and documentation). As such, cannabis testing labs should rely on a LIMS that uses industry-standard communication protocols and encryption methods to protect not only the data housed in the LIMS but also data moving in and out of it.


Accounting and billing

Cannabis testing LIMS requirement: The system should provide accounting and billing functionality for not only optimal business operations but also to ensure compliance with any regulations involving monetary transactions for cannabis-related services.

Relevant LIMSpec:

  • Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec.

Additional background: Though not necessarily backed by any regulation or standard, carefully tracking expenditures and payments received related to cannabis activities is vital. This is especially true given that the non-hemp (low-THC) Cannabis plant is still technically illegal to grow and process in the eyes of U.S. federal law. As such, some business taking in money from cannabis-related activities have had problems with managing the financial aspects of their operations.[5][6][7][8] Given the remaining uncertainty of cannabis legalization in the U.S., and the natural benefits of managing accounting and billing within the LIMS, it makes sense that a LIMS should be able to accurately track receipts and more, down to the penny.


Secure web portal

Cannabis testing LIMS requirement: The system should provide a secure web portal for client results review and test ordering.

Relevant LIMSpec:

  • Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec.

Additional background: Similar to accounting and billing functionality, this requirement for a portal for customer access isn't necessarily mandated by any regulation or standard. However, it remains a useful time-saving and customer service element. Additionally, the "secure" part of this requirement must be emphasized. This ties directly to the prior requirement for data security and confidentiality. Web-based attacks remain some of the most popular cybersecurity attacks, targeting the likes of online customer portals and WordPress sites for credentials and sensitive information.[9][10] A quality LIMS that has already proven strong data security gives confidence in the LIMS vendor's ability to implement a web-based customer portal for order review and test ordering.


ISO/IEC 17025 compliance support

Cannabis testing LIMS requirement: The system should support a laboratory's ISO/IEC 17025 compliance efforts.

Relevant LIMSpec:

  • 1.13 The system shall assign each sample registered in the system a unique identifier using methodologies such as an ID with an incrementing integer or a user-defined naming format.
  • 2.8 The system should allow for the accurate identification of a physical sample in the system via barcode or RFID technology.
  • 4.4 The system shall provide one or more levels of review, as well as interpretation and documentation of results—whether entered manually or via an automated process—before release.
  • 6.5 The system shall substantiate the status of verified results by using tools like a certificate of analysis, which shall include details like unique identifiers; analysis procedures used; reference intervals; environmental conditions; who provided the results; additional comments, opinions, and interpretations and who provided them; and applicable times and dates.
  • 6.9 The system shall clearly identify a changed, amended, or re-issued report as being such, and clearly identify any change of information and reason for change in such a report.
  • 7.1 The system shall be capable of creating, managing, and securely holding a variety of document types, while also allowing for the review and approval of those documents using version and release controls.
  • 7.2 The system shall have the ability to readily provide access to electronic documents such as standard operating procedures, quality manuals, instrument manuals, information exchange agreements, and other applicable documents to designated personnel and officials.
  • 7.3 The system shall be able to clearly provide the most current version of a document and archive prior versions.
  • 7.5 The system shall allow the creation, approval, rejection, and management of sampling and test methods performed at the laboratory, capturing details about the test method, method reference, specifications, assigned limits, holding times, etc. as required by a reference method or regulation.
  • 7.6 The system shall provide a means for recording validation information for modified existing or new in-house test methods, either as a method itself or through some other means. Validation information such as procedures used, specifications, performance characteristics, and results obtained shall be allowed as input.
  • 7.7 The system shall maintain training and certification records for personnel and allow the assignment of available training paths and certifications to specific personnel, such that only trained, certified, and experienced personnel are able to perform assigned tasks.
  • 8.8 The system shall map available system tasks (such as approved test methods) or sample types (such as select agents and toxins) to available training paths and certifications, such that only trained, certified, and experienced personnel are able to perform assigned tasks.
  • 10.7 The system shall allow for the configuration of calibration and maintenance frequency and time frames for—as well as the manual and automatic scheduling of calibration or maintenance of—equipment, instruments, and systems. Available intervals should be include days, weeks, months, and years.
  • 10.9 The system shall clearly identify any instrument that is out-of-calibration, beyond its preventative maintenance due date, or under investigation and prevent it from being selected for use.
  • 10.10 The system shall be able to show all instances of scheduled calibration, preventative maintenance, and service dates for an instrument.
  • 10.11 The system shall be able to link a calibration activity to certified reference material or designated measurement processes.
  • 10.13 The system shall be able to uniquely identify each instrument and any associated components and maintain that and other information—such as manufacturer, model number, serial number, and calibration and maintenance history—within the system.
  • 10.15 The system shall be capable of chronologically logging details for scheduled and unscheduled calibration and maintenance activities for each instrument, including calibration status, calibration standard, date and time of calibration or maintenance, work performed, who conducted it, and signatures of those verifying the completed activities.
  • 16.3 The system shall be able to record instances of identified nonconformance and method deviation, as well as the actions required to restore the process to conformity. In the case of a planned deviation, the system shall require documentation, justification, proof of validation, adjusted reference intervals, and authorization for the deviated process.
  • 27.3 The system shall provide a means to choose—based on date and type of data—electronic data and metadata to archive.
  • 27.4 The system shall provide a guaranteed means to retrieve and restore archived data and metadata that is readable and accurate.
  • 27.11 The system’s data storage tools shall provide data backup and retrieval functions that meet or exceed industry best practices, including producing exact and complete backups that are secure from manipulation and loss.
  • 30.9 The system should allow for other types of facility monitoring (such as alarm, light, lock, and door statuses) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored systems and their status changes.
  • 30.11 The system should allow for environmental control and monitoring of equipment (such as incubators and freezers) and send notifications when necessary with recommendations for immediate and corrective action. The system should also maintain a log of all such monitored equipment and their associated status changes.
  • 31.4 The system shall have a mechanism to securely retain data in the system for a specific time period and enable protections that ensure the accurate and ready retrieval of that data throughout the records retention period.
  • 32.22 The system shall provide a security interface usable across all modules of the system that secures data and operations and prevents unauthorized access to data and functions.
  • 33.4 The system should be well documented by the vendor in comprehensive training material for all aspects of system use, including administration, operation, and troubleshooting.
  • 33.5 The system shall be validated initially and periodically, with those validation activities being documented, to ensure the accuracy, consistency, and reliability of system performance and its electronic records.
  • 34.7 The vendor shall restrict logical access to database storage components to authorized individuals. If providing a hosted service, the vendor should also restrict physical access to database storage components to authorized individuals. (In the case of an on-site solution, the buyer is responsible for limiting physical access to database storage components to meet 21 CFR Part 11, HIPAA, and CJIS guidelines.)

Additional background: In the U.S., many states mandate analytical testing of cannabis and its related products. This testing is prescribed as a public health safety measure, to ensure those consuming cannabis and derived products are not adversely affected by any harmful substances picked up during processing stages. By extension the public must place trust in those labs conducting this testing, requiring a high level of quality within the laboratory and how it operates. This quality is better assured through laboratory accreditation checks to standards like ISO/IEC 17025, which provides competence requirements for testing and calibration laboratories. ISO/IEC 17025 requirements are non-trivial, covering many aspects of how the laboratory operates, and chief among those requirements is the need for a quality management system. And maintaining quality requires maintaining traceable documentary evidence of those efforts.[11] This includes certificates of analysis, quality manuals, standard operating procedures, calibration and maintenance logs, and much more. Your LIMS should make strong efforts towards helping you maintain that documentary evidence to not only assist with compliance efforts, but also push your lab to maintain high levels of quality for those depending on accurate analyses.


NELAC, ORELAP, and ELAP compliance support

Cannabis testing LIMS requirement: The system should support a laboratory's NELAC or ORELAP compliance efforts.

Cannabis testing LIMS requirement: The system should support a laboratory's ELAP compliance efforts.

Relevant LIMSpec:

  • NOTE: NELAC's Volume 1: Management and Technical Requirements for Laboratories Performing Environmental Analysis (2016) is proprietary and could not be obtained. The following LIMSpec items are based off New York's ELAP requirements.
  • 2.11 The system shall allow samples and tests to be created and used specifically for capturing data related to unique forms of sampling and testing such as representative sampling, calibration testing, quality control testing, preventative maintenance testing, stability testing, sterility testing, compatibility testing, identity testing, proficiency testing, and service-event-related testing.
  • 7.1 The system shall be capable of creating, managing, and securely holding a variety of document types, while also allowing for the review and approval of those documents using version and release controls.
  • 7.2 The system shall have the ability to readily provide access to electronic documents such as standard operating procedures, quality manuals, instrument manuals, information exchange agreements, and other applicable documents to designated personnel and officials.
  • 7.5 The system shall allow the creation, approval, rejection, and management of sampling and test methods performed at the laboratory, capturing details about the test method, method reference, specifications, assigned limits, holding times, etc. as required by a reference method or regulation.
  • 7.6 The system shall provide a means for recording validation information for modified existing or new in-house test methods, either as a method itself or through some other means. Validation information such as procedures used, specifications, performance characteristics, and results obtained shall be allowed as input.
  • 7.7 The system shall maintain training and certification records for personnel and allow the assignment of available training paths and certifications to specific personnel, such that only trained, certified, and experienced personnel are able to perform assigned tasks.
  • 16.6 The system shall allow for the documentation of and corrective and preventive action towards all types of nonconformance.
  • 16.7 The system should track and record incidents and associated corrective actions, allowing authorized personnel to document the effectiveness of the actions, identify insufficient resolutions, and curb repeat occurrences.

Additional background: Though ISO/IEC 17025 remains the major standard to be accredited to, other accreditation requirements exist in the world of cannabis testing. These requirements may be state-based, as with the Oregon Environmental Laboratory Accreditation Program (ORELAP)[12] or New York's Environmental Laboratory Approval Program, Certification Manual Item 180.7 for Medical Marijuana.[13] Others like the non-profit NELAC Institute provide national accreditation thought its National Environmental Laboratory Accreditation Program (NELAP), which ORELAP is largely guided by.[12] This includes NELAC's[14]:

  • EL-V1M1-2016-Rev2.1 Module 1, "Proficiency Testing"
  • EL-V1M2-ISO-2016-Rev2.1 Module 2 "Quality Systems General Requirements"
  • EL-V1M4-2017-Rev2.2 Module 4, "Quality Systems for Chemical Testing"
  • EL-V1M5-2016-Rev2.0 Module 5, "Quality Systems for Microbiological Testing"

As such, this means covering ground similar to ISO/IEC 17025 regarding quality in the laboratory. To better meet these requirements, a cannabis testing LIMS should assist with the maintenance of documentation such as quality manuals, tracking laboratorians' credentials and experience, documenting corrective and preventative action, and documenting proficiency testing results, among other tasks.[15]


Patient Focused Certification (PFC) compliance support

Cannabis testing LIMS requirement: The system should support a laboratory's Americans for Safe Access (ASA) Patient Focused Certification (PFC) Program laboratory compliance efforts.

Relevant LIMSpec:

  • Unknown; unable to acquire document

Additional background: The American Association for Laboratory Accreditation (A2LA) incorporates the ASA's PFC Program into its cannabis testing laboratory accreditation, described in its R243 - Specific Requirements - Cannabis Testing Laboratory Accreditation Program document.[16] However, the A2LA will "only give that document to prospective accreditation customers," according to personal communication. As such, it's not clear what those specific PFC requirements are and how they may relate to a LIMS' ability to maintain A2LA's PFC compliance. Presumably those requirements can be better met with a LIMS, whatever the requirements may be. If a vendor indicates their LIMS helps support PFC requirements, it's best to engage in a conversion with the vendor to determine how.

References

  1. ↑ LabLynx, Inc (13 October 2011). "LabLynx KB:SysAdmin - 5.4 LIMS system setup". LIMSwiki.org. https://www.limswiki.org/index.php/LabLynx_KB:SysAdmin_-_5.4_LIMS_system_setup. Retrieved 18 December 2020. 
  2. ↑ Moberly, R. (14 May 2020). "Avoid Infractions: Top 5 METRC Cultivation Violations". RMCC Blog. https://www.rockymountaincannabisconsulting.com/cannabis-business-blog/2020/5/14/avoid-infractions-top-5-metrc-cultivation-violations. Retrieved 18 December 2020. 
  3. ↑ Fawkes, G. (24 January 2020). "Report: Cannabis Users’ Sensitive Data Exposed in Data Breach". vpnMentor Blog. https://www.vpnmentor.com/blog/report-thsuite-breach/. Retrieved 20 January 2020. 
  4. ↑ Shaghaghi, S.; Weinstein, I. (18 February 2020). "Leak of 30,000 cannabis customer records heightens need for effective data security". Insights. CohnReznick LLP. https://www.cohnreznick.com/insights/leak-of-30000-cannabis-customer-records-heightens-need-for-effective-data-security. Retrieved 20 January 2020. 
  5. ↑ Kovaleski, S.F. (14 February 2014). "U.S. Issues Marijuana Guidelines for Banks". The New York Times. The New York Times Corporation. https://www.nytimes.com/2014/02/15/us/us-issues-marijuana-guidelines-for-banks.html. Retrieved 18 December 2020. 
  6. ↑ Financial Crimes Enforcement Network (14 February 2014). "BSA Expectations Regarding Marijuana-Related Businesses". U.S. Department of the Treasury. https://www.fincen.gov/resources/statutes-regulations/guidance/bsa-expectations-regarding-marijuana-related-businesses. Retrieved 18 December 2020. 
  7. ↑ Angell, T. (14 June 2018). "More Banks Working With Marijuana Businesses, Despite Federal Moves". Forbes. Forbes Media, LLC. https://www.forbes.com/sites/tomangell/2018/06/14/more-banks-working-with-marijuana-businesses-despite-federal-moves/#4d828ed21b1b. Retrieved 18 December 2020. 
  8. ↑ Boomstein, A.L.; Miller, C.D.; Owen, J.L. (30 October 2019). "California DBO Offers Guidance on Cannabis Banking". Manatt, Phelps & Phillips, LLP. https://www.manatt.com/insights/newsletters/financial-services-law/california-dbo-offers-guidance-on-cannabis-banking. Retrieved 18 December 2020. 
  9. ↑ Talalev, A. (14 September 2020). "Website Hacking Statistics in 2020". WebARX Blog. https://www.webarxsecurity.com/website-hacking-statistics-2018-february/. Retrieved 18 December 2020. 
  10. ↑ Ensighten (11 February 2020). "op Five Cyberattacks Targeting Your Website in 2020". Ensighten Blog. https://www.ensighten.com/blog/top-five-cyberattacks-targeting-your-website-in-2020. Retrieved 18 December 2020. 
  11. ↑ JonP (31 July 2020). "How can a cannabis testing lab pass ISO 17025?". IMSM News. https://www.imsm.com/us/news/how-can-a-cannabis-testing-lab-pass-iso-17025/. Retrieved 23 December 2020. 
  12. ↑ 12.0 12.1 "Accreditation for Laboratories Testing Cannabis in Oregon". Oregon Health Authority. https://www.oregon.gov/oha/ph/LaboratoryServices/EnvironmentalLaboratoryAccreditation/Pages/Cannabis-accreditation.aspx. Retrieved 23 December 2020. 
  13. ↑ "Environmental Laboratory Approval Program". New York State Department of Health Wadsworth Center. https://www.wadsworth.org/regulatory/elap. Retrieved 23 December 2020. 
  14. ↑ "Fla. Admin. Code R. 64E-1.0015". CaseText. 8 December 2020. https://casetext.com/regulation/florida-administrative-code/department-64-department-of-health/division-64e-division-of-environmental-health/chapter-64e-1-certification-of-environmental-testing-laboratories/section-64e-10015-laboratory-certification-standards. Retrieved 23 December 2020. 
  15. ↑ New York State Department of Health – Wadsworth Center (3 December 2020). "Environmental Laboratory Approval Program (ELAP) and Laboratory of Environmental Biology (LEB): Procedure on How to Perform an Initial Demonstration of Capability (iDOC) for Medical Marijuana Microbiology" (PDF). New York Department of Health. https://www.wadsworth.org/sites/default/files/WebDoc/MM%20guidance%20procedure%20for%20Micro%20iDOC-120320.pdf. Retrieved 23 December 2020. 
  16. ↑ A2LA. "Cannabis Testing Laboratory Accreditation Program". https://www.a2la.org/accreditation/cannabis-testing. Retrieved 23 December 2020. 
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