Difference between revisions of "User:Shawndouglas/sandbox/sublevel10"

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With a few minor exceptions (e.g., Colorado's limitation that "a Medical Marijuana Testing Facility shall not perform testing on Industrial Hemp"<ref name="SOSMedicalMari">{{cite web |url=https://www.sos.state.co.us/CCR/GenerateRulePdf.do?ruleVersionId=7094&fileName=1 CCR 212-1 |title=Medical Marijuana Rules - 1 CCR 212-1 |author=Department of Revenue, Marijuana Enforcement Division |publisher=Colorado Secretary of State |accessdate=07 July 2021}}</ref>), a laboratory licensed to analyze medical marijuana or recreational cannabis is most likely able to branch out to not only other types of cannabis testing but also testing within other markets. Consider the equipment most commonly used in cannabis analysis: [[chromatography]], [[spectroscopy]], [[mass spectrometry]], and [[polymerase chain reaction]] systems. What other types of laboratory testing use that sort of equipment? Environmental science laboratories are definitely using such equipment<ref name="PicóChroma20">{{cite journal |title=Chromatography–mass spectrometry: Recent evolution and current trends in environmental science |journal=Current Opinion in Environmental Science & Health |author=Picó, Y. |volume=18 |pages=47–53 |year=2020 |doi=10.1016/j.coesh.2020.07.002}}</ref>, arguably representing one of the easier lateral market expansions a cannabis testing lab can take. Food and beverage analyses also depend on all those equipment types<ref name="SchieberIntro08">{{cite book |chapter=Chapter 1: Introduction to Food Authentication |title=Modern Techniques for Food Authentication |author=Schieber, A. |editor=Sun, D.-W. |publisher=Elsevier |pages=1–17 |year=2008 |isbn=9780123740854}}</ref><ref name="RasheedNovel21">{{cite journal |title=Novel trends and applications of multidimensional chromatography in the analysis of food, cosmetics and medicine bearing essential oils |journal=Talanta |author=Rasheed, D.M.; Serag, A.; Shakour, Z.T.A. et al. |volume=223 |issue=1 |at=121710 |year=2021 |doi=10.1016/j.talanta.2020.121710}}</ref>, as do other forms of testing such as agricultural testing<ref name="LippPoly05">{{cite journal |title=Polymerase chain reaction technology as analytical tool in agricultural biotechnology |journal=Journal of AOAC International |author=Lipp, M.; Shilito, R.; Giroux, R. et al. |volume=88 |issue=1 |pages=136–55 |pmid=15759736}}</ref><ref name="WacooMethods14">{{cite journal |title=Methods for Detection of Aflatoxins in Agricultural Food Crops |journal=Journal of Applied Chemistry |author=Wacoo, A.P.; Wendiro, D.; Vuzi, P.C. et al. |volume=2014 |at=706291 |year=2014 |doi=10.1155/2014/706291}}</ref>, cosmetic testing<ref name="RasheedNovel21" /><ref name="JannatGelatin18">{{cite journal |title=Gelatin speciation using real-time PCR and analysis of mass spectrometry-based proteomics datasets |journal=Food Control |author=Jannat, B.; Ghorbani, K.; Shafieynan, H. et al. |volume=87 |pages=79–87 |year=2018 |doi=10.1016/j.foodcont.2017.12.006}}</ref>, and petrochemical testing.<ref name="KhanmohammadiCharct12">{{cite journal |title=Characterization of petroleum-based products by infrared spectroscopy and chemometrics |journal=TrAC Trends in Analytical Chemistry |author=Khanmohammadi, M.; Garmarudi, A.B.; de la Guardia, M. |volume=35 |pages=135–49 |year=2012 |doi=10.1016/j.trac.2011.12.006}}</ref><ref name="ImamAnal19">{{cite journal |title=Analytical approaches used in monitoring the bioremediation of hydrocarbons in petroleum-contaminated soil and sludge |journal=TrAC Trends in Analytical Chemistry |author=Imam, A.; Suman, S.K.; Ghosh, D. et al. |volume=118 |pages=50–64 |year=2019 |doi=10.1016/j.trac.2019.05.023}}</ref> Assuming a lab has or can acquire the in-house expertise for analyzing all these related matrices, analytes, and molecules, as well as the regulatory know-how (e.g., Environmental Protection Agency testing methodologies) and licensing, expanding into other markets beyond cannabis testing may be a realistic long-term proposition.
[[File:Programmer writing code with Unit Tests.jpg|right|450px]]Now that you have a rudimentary understanding of informatics in the cannabis testing lab, as well as the value of having a solution that is flexible, it's time to discuss the core of what makes a cannabis testing LIMS really shine. What are those vital features that distinguish a cannabis testing LIMS from an all-purpose solution? What challenges is the system truly poised to help you with in the lab?


If your lab is realistically considering this sort of market expansion, it's in your lab's best interest to consider a LIMS that is flexible enough to allow for the expansion of its portfolio of tests, protocols, workflows, and other laboratory management tools beyond those required for cannabis testing. Yes, a quality LIMS built for cannabis testing will offer preloaded cannabis testing protocols, labels, and analytical reports, as well as the ability to add new and customize existing protocols, labels, and analytical reports as standard methods and regulatory requirements evolve. Such a LIMS will also provide flexible specification limit sets for quality control, third-party system integrations with reporting and business solutions, instrument interfacing for all those chromatography and mass spectrometry devices, granular chain-of-custody, real-time alerts, issue tracking, and workload monitoring, to name a few. But all that functionality has important cross-over to environmental, food and beverage, cosmetic, and petrochemical analyses as well, including the ability to add and modify tests, protocols, and workflows associated with those analyses within the LIMS.
A broad all-purpose LIMS will fill many a laboratory's needs; however, the cannabis testing laboratory requires a little more out of the LIMS it implements. A purposeful cannabis testing LIMS will address a number of important needs, described in Table 2.<ref name="BirosUsing15">{{cite web |url=https://cannabisindustryjournal.com/feature_article/using-lims-in-cannabis-laboratories/ |title=Using LIMS in Cannabis Laboratories |author=Biros, A.G. |work=Cannabis Industry Journal |publisher=Innovative Publishing Co. LLC |date=23 October 2015 |accessdate=07 July 2021}}</ref><ref name="AudinoManag18">{{cite web |url=https://cannabisindustryjournal.com/feature_article/managing-cannabis-testing-lab-workflows-using-lims/ |title=Managing Cannabis Testing Lab Workflows Using LIMS |author=Audino, S. |work=Cannabis Industry Journal |date=07 February 2018 |accessdate=07 July 2021}}</ref><ref name="PaszkoSelecting18">{{cite web |url=https://www.labcompare.com/10-Featured-Articles/354722-Selecting-a-LIMS-for-the-Cannabis-Industry/ |title=Selecting a LIMS for the Cannabis Industry |author=Paszko, C. |work=LabCompare |date=27 November 2018 |accessdate=07 July 2021}}</ref>


This brings up another significant question to consider in cannabis testing LIMS acquisition: how flexible is your LIMS? How configurable is it? How customizable is it, despite some base similarities in requirements with other testing markets? Aspects of a LIMS lending to an expansion into other markets include:
{|
 
| STYLE="vertical-align:top;"|
* having the tools for creating and customizing sample registration screens for sample types beyond cannabis-related ones;
{| class="wikitable" border="1" cellpadding="5" cellspacing="0" width="90%"
* having the tools for creating new, compliant test protocols, labels, and reports, as well as for managing them as industries change;
|-
* offering sufficiently flexible protocol creation for adding most any specification limit sets, measurement units, substrates/matrices, etc.;
  | style="background-color:white; padding-left:10px; padding-right:10px;" colspan="2"|'''Table 2.''' What a purposeful cannabis testing LIMS will address for a lab
* being able to integrate with instruments and software systems beyond those common to cannabis testing labs, including handling most any API thrown at it; and
|-
* having the functionality to help laboratories comply with the wide variety of standards and regulations found in other testing markets.
  ! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;"|Cannabis testing need
 
  ! style="background-color:#e2e2e2; padding-left:10px; padding-right:10px;"|Details
Even in 2021, as legalization efforts continue to march forward in the U.S. and standard methods continue to be developed, cannabis testing laboratories still face a number of challenges.<ref name="KaulManag20">{{cite web |url=https://www.labmanager.com/business-management/managing-a-cannabis-lab-22822 |title=Managing a Cannabis Lab |author=Kaul, S. |work=Lab Manager |date=03 June 2020 |accessdate=07 July 2021}}</ref> Using automation tools like a LIMS is one way to overcome those challenges, particularly as the cannabis testing space gets more crowded, driving prices downward.<ref name="KaulManag20" /> However, you want to be sure the LIMS you choose is not only compatible with your budget but also able to tackle all your current and future testing needs, while helping you streamline processes and improve workflows. A sturdy LIMS capable of managing cannabis analyses while being flexible enough to allow your lab—whether you're an existing lab wanting to expand into other markets or a start-up lab eyeing broad horizons—to handle other analyses will be highly valuable in a time when the status of the fledgling cannabis industry continues to be in flux. In the end, no matter what type of lab you represent, your laboratory business model will be one to minimize risk while maximizing income. As such, diversifying into other markets with a flexible LIMS just makes sense.
|-
  | style="background-color:white; padding-left:10px; padding-right:10px;"|''Configurable sample registration screens optimized for the cannabis testing industry''
  | style="background-color:white; padding-left:10px; padding-right:10px;"|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.
|-
  | style="background-color:white; padding-left:10px; padding-right:10px;"|''Pre-loaded cannabis testing protocols, labels, and analytical reports''
  | style="background-color:white; padding-left:10px; padding-right:10px;"|End users of a cannabis testing LIMS will appreciate having a wide array of pre-loaded testing protocols, label templates, and report templates that support the testing of acid and neutral forms of cannabinoids, potency, strain, water activity, moisture content, pesticides, solvents, heavy metals, microbiological contaminates, fungi, mycotoxins, and foreign matter. This includes the ability to configure measurement units, as well as customize analytical reports such as certificates of analysis (COAs) for multiple state- and locally regulated testing scenarios.
|-
  | style="background-color:white; padding-left:10px; padding-right:10px;"|''Support for the creation and management of additional protocols, labels, and analytical reports''
  | style="background-color:white; padding-left:10px; padding-right:10px;"|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 critical.
|-
  | style="background-color:white; padding-left:10px; padding-right:10px;"|''Flexible specification limit sets for quality control''
  | style="background-color:white; padding-left:10px; padding-right:10px;"|A vital component of 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/matrices—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=07 July 2021}}</ref> These limit sets can help improve quality control and the reporting of out-of-specification (OOS) samples and results.
|-
  | style="background-color:white; padding-left:10px; padding-right:10px;"|''Third-party system integration, with strong support for APIs for track-and-trace and other legally mandated reporting systems''
  | style="background-color:white; padding-left:10px; padding-right:10px;"|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.
|-
  | style="background-color:white; padding-left:10px; padding-right:10px;"|''Instrument integration with the instrument data systems common to cannabis testing''
  | style="background-color:white; padding-left:10px; padding-right:10px;"|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 (TAT) 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.
|-
  | style="background-color:white; padding-left:10px; padding-right:10px;"|''Granular chain-of-custody at every step''
  | style="background-color:white; padding-left:10px; padding-right:10px;"| A seed-to-sale or "track-and-trace" system means 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 that received cannabis materials go through, from reception and retention to delivery and destruction.
|-
  | style="background-color:white; padding-left:10px; padding-right:10px;"|''Inventory reconciliation, including sample weight reconciliation''
  | style="background-color:white; padding-left:10px; padding-right:10px;"|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=07 July 2021}}</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.
|-
  | style="background-color:white; padding-left:10px; padding-right:10px;"|''Real-time alerts and issue tracking''
  | style="background-color:white; padding-left:10px; padding-right:10px;"|The requirement for maintaining quality testing outcomes for consumer safety and client satisfaction drives the need for prompt real-time alerts. Users must clearly and promptly be notified of errors and OOS results (via limit sets and other triggers) in order to, for example, identify health risks associated with a tested product or discover mislabeled product. These OOS results, as well as any other problems, should be tracked not only to notify clients but also to guide corrective action. Alerts and issue tracking are also useful for ensuring scheduled tasks are completed before they are due, or correcting processes if tests inadvertently become overdue.
|-
  | style="background-color:white; padding-left:10px; padding-right:10px;"|''Capacity and performance monitoring''
  | style="background-color:white; padding-left:10px; padding-right:10px;"|Whether an R&D cannabis lab or a quality assurance lab for cannabis, monitoring workloads, instrument allocations, scheduled tasks, OOS results, and any lab-specific performance indicators is vital for ensuring quick turnaround time (TAT), accurate results, productive workflows, and positive regulatory outcomes. Similar to issue tracking, capacity and performance tracking also help maintain quality testing outcomes and client satisfaction. Custom key performance measure (KPM) creation and management is also useful towards those efforts.
|-
  | style="background-color:white; padding-left:10px; padding-right:10px;"|''Strong data security and confidentiality''
  | style="background-color:white; padding-left:10px; padding-right:10px;"|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=07 July 2021}}</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=07 July 2021}}</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.
|-
  | style="background-color:white; padding-left:10px; padding-right:10px;"|''Accounting and billing support, including quoting and invoicing''
  | style="background-color:white; padding-left:10px; padding-right:10px;"|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=07 July 2021}}</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=07 July 2021}}</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=07 July 2021}}</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=07 July 2021}}</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.
|-
  | style="background-color:white; padding-left:10px; padding-right:10px;"|''Secure web portal for client results review and test ordering''
  | style="background-color:white; padding-left:10px; padding-right:10px;"|Clients appreciate being able to submit test orders and view the results of their tests on a relatively independent basis. The secure web portal makes a useful time-saving and customer-friendly tool in that effort. However, the "secure" part of this requirement must be emphasized. 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://patchstack.com/website-hacking-statistics/ |title=Website Hacking Statistics You Should Know in 2021 |author=Talalev, A. |work=WebARX Blog |date=22 February 2021 |accessdate=07 July 2021}}</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=07 July 2021}}</ref> As indicated previously, a vendor that focuses on strong data security will have an advantage in the implementation of such a web portal.
|-
  | style="background-color:white; padding-left:10px; padding-right:10px;"|''Functionality supporting ISO/IEC 17025, NELAC, ORELAP, ELAP, and Patient Focused Certification (PFC) compliance''
  | style="background-color:white; padding-left:10px; padding-right:10px;"|Cannabis testing laboratories and their necessary focus on quality is driven by standards and regulations, as well as accreditation to those standards and regulations. That burden can at times be heavy for laboratories, so having automation elements like a LIMS that provides functionality that assists with complying with those standards and regulations is immensely helpful. For example, ISO/IEC 17025 has a requirement that documents be managed in a specific way, an area where a well-designed LIMS is able to help.  
|-
|}
|}


==References==
==References==
{{Reflist|colwidth=30em}}
{{Reflist|colwidth=30em}}

Revision as of 17:35, 19 August 2021

Programmer writing code with Unit Tests.jpg

Now that you have a rudimentary understanding of informatics in the cannabis testing lab, as well as the value of having a solution that is flexible, it's time to discuss the core of what makes a cannabis testing LIMS really shine. What are those vital features that distinguish a cannabis testing LIMS from an all-purpose solution? What challenges is the system truly poised to help you with in the lab?

A broad all-purpose LIMS will fill many a laboratory's needs; however, the cannabis testing laboratory requires a little more out of the LIMS it implements. A purposeful cannabis testing LIMS will address a number of important needs, described in Table 2.[1][2][3]

Table 2. What a purposeful cannabis testing LIMS will address for a lab
Cannabis testing need Details
Configurable sample registration screens optimized for the cannabis testing industry 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.
Pre-loaded cannabis testing protocols, labels, and analytical reports End users of a cannabis testing LIMS will appreciate having a wide array of pre-loaded testing protocols, label templates, and report templates that support the testing of acid and neutral forms of cannabinoids, potency, strain, water activity, moisture content, pesticides, solvents, heavy metals, microbiological contaminates, fungi, mycotoxins, and foreign matter. This includes the ability to configure measurement units, as well as customize analytical reports such as certificates of analysis (COAs) for multiple state- and locally regulated testing scenarios.
Support for the creation and management of additional protocols, labels, and analytical reports 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 critical.
Flexible specification limit sets for quality control A vital component of 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/matrices—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.[4] These limit sets can help improve quality control and the reporting of out-of-specification (OOS) samples and results.
Third-party system integration, with strong support for APIs for track-and-trace and other legally mandated reporting systems 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 with the instrument data systems common to cannabis testing 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 (TAT) 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 at every step A seed-to-sale or "track-and-trace" system means 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 that received cannabis materials go through, from reception and retention to delivery and destruction.
Inventory reconciliation, including sample weight reconciliation Related to the "how much" of chain-of-custody tracking, sample weight reconciliation is an important element of avoiding regulatory violations.[5] 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.
Real-time alerts and issue tracking The requirement for maintaining quality testing outcomes for consumer safety and client satisfaction drives the need for prompt real-time alerts. Users must clearly and promptly be notified of errors and OOS results (via limit sets and other triggers) in order to, for example, identify health risks associated with a tested product or discover mislabeled product. These OOS results, as well as any other problems, should be tracked not only to notify clients but also to guide corrective action. Alerts and issue tracking are also useful for ensuring scheduled tasks are completed before they are due, or correcting processes if tests inadvertently become overdue.
Capacity and performance monitoring Whether an R&D cannabis lab or a quality assurance lab for cannabis, monitoring workloads, instrument allocations, scheduled tasks, OOS results, and any lab-specific performance indicators is vital for ensuring quick turnaround time (TAT), accurate results, productive workflows, and positive regulatory outcomes. Similar to issue tracking, capacity and performance tracking also help maintain quality testing outcomes and client satisfaction. Custom key performance measure (KPM) creation and management is also useful towards those efforts.
Strong data security and confidentiality When it comes to cannabis and protected health information (PHI), dispensaries are the most likely to require careful attention to consumer information.[6][7] 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 support, including quoting and invoicing 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.[8][9][10][11] 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 for client results review and test ordering Clients appreciate being able to submit test orders and view the results of their tests on a relatively independent basis. The secure web portal makes a useful time-saving and customer-friendly tool in that effort. However, the "secure" part of this requirement must be emphasized. 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.[12][13] As indicated previously, a vendor that focuses on strong data security will have an advantage in the implementation of such a web portal.
Functionality supporting ISO/IEC 17025, NELAC, ORELAP, ELAP, and Patient Focused Certification (PFC) compliance Cannabis testing laboratories and their necessary focus on quality is driven by standards and regulations, as well as accreditation to those standards and regulations. That burden can at times be heavy for laboratories, so having automation elements like a LIMS that provides functionality that assists with complying with those standards and regulations is immensely helpful. For example, ISO/IEC 17025 has a requirement that documents be managed in a specific way, an area where a well-designed LIMS is able to help.

References

  1. Biros, A.G. (23 October 2015). "Using LIMS in Cannabis Laboratories". Cannabis Industry Journal. Innovative Publishing Co. LLC. https://cannabisindustryjournal.com/feature_article/using-lims-in-cannabis-laboratories/. Retrieved 07 July 2021. 
  2. Audino, S. (7 February 2018). "Managing Cannabis Testing Lab Workflows Using LIMS". Cannabis Industry Journal. https://cannabisindustryjournal.com/feature_article/managing-cannabis-testing-lab-workflows-using-lims/. Retrieved 07 July 2021. 
  3. Paszko, C. (27 November 2018). "Selecting a LIMS for the Cannabis Industry". LabCompare. https://www.labcompare.com/10-Featured-Articles/354722-Selecting-a-LIMS-for-the-Cannabis-Industry/. Retrieved 07 July 2021. 
  4. 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 07 July 2021. 
  5. 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 07 July 2021. 
  6. 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 07 July 2021. 
  7. 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 07 July 2021. 
  8. 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 07 July 2021. 
  9. 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 07 July 2021. 
  10. 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 07 July 2021. 
  11. 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 07 July 2021. 
  12. Talalev, A. (22 February 2021). "Website Hacking Statistics You Should Know in 2021". WebARX Blog. https://patchstack.com/website-hacking-statistics/. Retrieved 07 July 2021. 
  13. 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 07 July 2021.