Difference between revisions of "User:Shawndouglas/sandbox/sublevel5"

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The LIMS has been a useful tool for laboratories since at least the 1980s, aiding with sample reception and management, test management, instrument management, and reporting.<ref name="LIMSHistory">{{cite journal |title=A brief history of LIMS |journal=Laboratory Automation and Information Management |author=Gibbon, G.A. |volume=32 |issue=1 |pages=1–5 |year=1996 |doi=10.1016/1381-141X(95)00024-K}}</ref><ref name="McLelland98">{{cite web |url=http://www.rsc.org/pdf/andiv/tech.pdf |archiveurl=https://web.archive.org/web/20131004232754/http://www.rsc.org/pdf/andiv/tech.pdf |format=PDF |title=What is a LIMS - a laboratory toy, or a critical IT component? |author=McLelland, A. |publisher=Royal Society of Chemistry |page=1 |date=1998 |archivedate=04 October 2013 |accessdate=23 January 2021}}</ref> Since its humble origins, the software has expanded to include a wide variety of additional functionality to support laboratory operations, as well as the lab's ability to adhere to standards, certifications, and regulations. The technology behind how they are deployed has even changed, with both on-site and cloud-based installations now available.  
The LIMS has been a useful tool for laboratories since at least the 1980s, aiding with sample reception and management, test management, instrument management, and reporting.<ref name="LIMSHistory">{{cite journal |title=A brief history of LIMS |journal=Laboratory Automation and Information Management |author=Gibbon, G.A. |volume=32 |issue=1 |pages=1–5 |year=1996 |doi=10.1016/1381-141X(95)00024-K}}</ref><ref name="McLelland98">{{cite web |url=http://www.rsc.org/pdf/andiv/tech.pdf |archiveurl=https://web.archive.org/web/20131004232754/http://www.rsc.org/pdf/andiv/tech.pdf |format=PDF |title=What is a LIMS - a laboratory toy, or a critical IT component? |author=McLelland, A. |publisher=Royal Society of Chemistry |page=1 |date=1998 |archivedate=04 October 2013 |accessdate=23 January 2021}}</ref> Since its humble origins, the software has expanded to include a wide variety of additional functionality to support laboratory operations, as well as the lab's ability to adhere to standards, certifications, and regulations. The technology behind how they are deployed has even changed, with both on-site and cloud-based installations now available.  
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 needs such as<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=23 January 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=23 January 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=23 January 2021}}</ref>:
* configurable sample registration screens optimized for the cannabis testing industry;
* pre-loaded cannabis testing protocols, labels, and analytical reports;
* support for the creation and management of additional protocols, labels, and analytical reports;
* flexible specification limit sets for quality control;
* third-party system integration, with strong support for APIs for track-and-trace and other legally mandated reporting systems;
* instrument integration with the instrument data systems common to cannabis testing;
* granular chain-of-custody at every step;
* inventory reconciliation, including sample weight reconciliation;
* real-time alerts and issue tracking;
* capacity and performance monitoring;
* strong data security and confidentiality;
* accounting and billing support, including quoting and invoicing;
* secure web portal for client results review and test ordering; and
* functionality supporting ISO/IEC 17025, NELAC, ORELAP, ELAP, and Patient Focused Certification (PFC) compliance.


With so many vendor options, features, and requirements, the selection of a LIMS for cannabis testing can be a bewildering process, requiring significant research and consideration. Not only will you be looking for the above functionality, but you'll also want to ask other important questions. How useable and customizable is the software? Does it have sufficient mechanisms for ensuring the integrity of the data it houses and manages? How well does the vendor maintain the software with updates and patches?<ref name="KyobeSelect17">{{cite journal |title=Selecting a Laboratory Information Management System for Biorepositories in Low- and Middle-Income Countries: The H3Africa Experience and Lessons Learned |journal=Biopreservation and Biobanking |author=Kyobe, S.; Musinguzi, H.; Lwanga, N. et al. |volume=15 |issue=2 |pages=112–15 |year=2017 |doi=10.1089/bio.2017.0006}}</ref> These questions and more are required when preparing to add or change the LIMS in your laboratory, including asking the question, "how flexible is this LIMS?"
With so many vendor options, features, and requirements, the selection of a LIMS for cannabis testing can be a bewildering process, requiring significant research and consideration. Not only will you be looking for the above functionality, but you'll also want to ask other important questions. How useable and customizable is the software? Does it have sufficient mechanisms for ensuring the integrity of the data it houses and manages? How well does the vendor maintain the software with updates and patches?<ref name="KyobeSelect17">{{cite journal |title=Selecting a Laboratory Information Management System for Biorepositories in Low- and Middle-Income Countries: The H3Africa Experience and Lessons Learned |journal=Biopreservation and Biobanking |author=Kyobe, S.; Musinguzi, H.; Lwanga, N. et al. |volume=15 |issue=2 |pages=112–15 |year=2017 |doi=10.1089/bio.2017.0006}}</ref> These questions and more are required when preparing to add or change the LIMS in your laboratory, including asking the question, "how flexible is this LIMS?"
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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" /> 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 to handle other analyses will be highly valuable in a time when the status of the fledgling cannabis industry continues to be in flux.
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" /> 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 to handle other analyses will be highly valuable in a time when the status of the fledgling cannabis industry continues to be in flux.


===3.3 Systems selection, implementation, and integration===
===3.3 Cannabis LIMS considerations===
[[File:Programmer writing code with Unit Tests.jpg|right|400px]]When selecting a cannabis testing LIMS, there are two questions to ask at the outset:
[[File:Programmer writing code with Unit Tests.jpg|right|400px]]


1. What do I want the LIMS to do for me?
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 needs such as<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=23 January 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=23 January 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=23 January 2021}}</ref>:
 
2. What kind of budget do I have?
 
The answer to the first question is largely the same as most other kinds of labs. The benefits a LIMS provides includes:
 
* increased accuracy: the minimization or elimination of transcription and other errors;
* streamlined processes: ensuring each process step in a protocol/method is completed in the proper order, with all requirements met, updating sample statuses automatically;
* automation: integration with instruments, allowing for automatic uploading of samples and returning of results;
* regulatory and standards compliance: functionality that aids with compliance, including reporting results to state and local authorities;
* data security: role-based, configurable, secure access to data, processes, reporting, etc.;
* custom reporting: reporting tools that allows for the design and generation of certificates of authority and other reports to lab- and regulation-based specs;
* instant data retrieval: query tools for finding data instantly according to any criteria (date range, test, product type, etc.); and
* configurability and cost-effectiveness: a user-configurable system (as opposed to hard-coded, requiring development for any modifications) that is flexible enough to adapt to rapid changes in test volume and type over time, without breaking the bank.
 
Addressing the second question concerning budget is more difficult, as a cannabis testing LIMS comes in all kinds of price ranges. How are you supposed to judge the appropriate system price for your lab? There are some basic realities that can help in figuring an appropriate budget:
 
:1. Vendor pricing is generally based on how many will be using the LIMS. This can be measured in concurrent users (how many will be using the LIMS at any one time) or named users (the number of total users who will ever use the LIMS, by name). Additionally, cannabis testing LIMS vendors increasingly offer the option of a cloud-hosted subscription, which of course has the advantage of not requiring  your own IT department, and allowing labs to defray cost over time, with little or no actual license fee. Think about your usage strategy and choose the pricing format that makes the most sense for you.
 
:2. Most costs are related to the work involved with installing, configuring, and migrating data to the LIMS. Try to choose a solution that has what you need out of the box, as much as possible. The more customized or unique options you ask for up-front, the more it tends to cost, as extra items are a function of the time it takes developers to add them.
 
:3. "User-configurable" beats "vendor-configurable" on cost-effectiveness. Many LIMS vendors offer a free or low-cost option, but don't be fooled. They are in business to make money, and they are counting on the fact that you'll need to pay them to make things work, add necessary functionality, and provide support and training. If you can find a vendor who offers a genuinely user-configurable LIMS, and whose manuals and other support materials are clearly helpful and available so that you can adjust things the way you want, when you want, then that will go a long way toward budget efficiency and longevity.
 
:4. Additional interfaces cost money. If necessary, consider phasing in any additional instrument and software interfaces over time, as revenue eases cash flow. You can go live with your LIMS operations more quickly, entering results manually until you can afford to interface your instruments one-by-one. This goes for reports as well; a simple reporting module that meets regulatory requirements will do. You can make fancier ones later.


* configurable sample registration screens optimized for the cannabis testing industry;
* pre-loaded cannabis testing protocols, labels, and analytical reports;
* support for the creation and management of additional protocols, labels, and analytical reports;
* flexible specification limit sets for quality control;
* third-party system integration, with strong support for APIs for track-and-trace and other legally mandated reporting systems;
* instrument integration with the instrument data systems common to cannabis testing;
* granular chain-of-custody at every step;
* inventory reconciliation, including sample weight reconciliation;
* real-time alerts and issue tracking;
* capacity and performance monitoring;
* strong data security and confidentiality;
* accounting and billing support, including quoting and invoicing;
* secure web portal for client results review and test ordering; and
* functionality supporting ISO/IEC 17025, NELAC, ORELAP, ELAP, and Patient Focused Certification (PFC) compliance.




Revision as of 21:17, 23 January 2021


-----Return to the beginning of this guide-----

3. LIMS, informatics, and cannabis testing

3.1 Informatics and automation in the cannabis testing lab

CBP Laboratories and Scientific Services (LSS), Springfield, Virginia - 44708018774.jpg

As seen in the previous chapters, analytical testing of cannabis is not a simple, one-size-fits-all process. Differing analytical matrices with a slightly fragmented but improving regulatory- and standards-based atmosphere, paired with downward pricing pressures and requests for quick turnaround times (TATs), means there are plenty of challenges for cannabis testing laboratories.[1][2] Workflows differ based upon the analyte being tested for and the substance in which they are contained. Sampling from and analyzing inflorescence material will look significantly different than sampling and analyzing from a cannabis edible, for example. The samples received in the lab must be tracked at every step, and results must be reported to not only clients but also state regulatory groups, typically in a secure electronic format. Quality control must be maintained, documents stored, and regulations followed. Managing all these and other aspects of the laboratory immersed in an already competitive industry leaves little room for failures. Applying automation in these cases may prove to be most beneficial.

Broadly speaking, adding elements of automation to the cannabis testing lab can help overcome the demand of rapidly analyzing large sample volumes of cannabis products with a wide spectrum of matrices.[1][2][3] Those automation elements can take many forms. Analytical lab Cannalysis, for example, has added middleware "that integrates instruments, optimizes workflows and monitors performance to create a cohesive lab ecosystem."[2] The Richland County Sheriff's Department Drug Identification Unit has turned to an automated dispersive pipette extraction (DPX) method with an automated liquid handler to speed up discriminate testing of cannabis' delta‐9‐tetrahydrocannabinol (THC) content.[4] And other laboratories are turning to a laboratory information management system (LIMS) for automating laboratory workflows, sample management, document management, and other aspects of cannabis lab testing.[5][6]

The LIMS has been a useful tool for laboratories since at least the 1980s, aiding with sample reception and management, test management, instrument management, and reporting.[7][8] Since its humble origins, the software has expanded to include a wide variety of additional functionality to support laboratory operations, as well as the lab's ability to adhere to standards, certifications, and regulations. The technology behind how they are deployed has even changed, with both on-site and cloud-based installations now available.

With so many vendor options, features, and requirements, the selection of a LIMS for cannabis testing can be a bewildering process, requiring significant research and consideration. Not only will you be looking for the above functionality, but you'll also want to ask other important questions. How useable and customizable is the software? Does it have sufficient mechanisms for ensuring the integrity of the data it houses and manages? How well does the vendor maintain the software with updates and patches?[9] These questions and more are required when preparing to add or change the LIMS in your laboratory, including asking the question, "how flexible is this LIMS?"

3.2 LIMS flexibility for cannabis testing and other markets

With a few minor exceptions (e.g., Colorado's limitation that "a Medical Marijuana Testing Facility shall not perform testing on Industrial Hemp"[10]), 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[11], 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[12][13], as do other forms of testing such as agricultural testing[14][15], cosmetic testing[13][16], and petrochemical testing.[17][18] 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.

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.

This brings up another big 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:

  • having the tools for creating and customizing sample registration screens for sample types beyond cannabis-related ones;
  • 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.;
  • 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.

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.[1] 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.[1] 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 to handle other analyses will be highly valuable in a time when the status of the fledgling cannabis industry continues to be in flux.

3.3 Cannabis LIMS considerations

Programmer writing code with Unit Tests.jpg

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 needs such as[19][20][21]:

  • configurable sample registration screens optimized for the cannabis testing industry;
  • pre-loaded cannabis testing protocols, labels, and analytical reports;
  • support for the creation and management of additional protocols, labels, and analytical reports;
  • flexible specification limit sets for quality control;
  • third-party system integration, with strong support for APIs for track-and-trace and other legally mandated reporting systems;
  • instrument integration with the instrument data systems common to cannabis testing;
  • granular chain-of-custody at every step;
  • inventory reconciliation, including sample weight reconciliation;
  • real-time alerts and issue tracking;
  • capacity and performance monitoring;
  • strong data security and confidentiality;
  • accounting and billing support, including quoting and invoicing;
  • secure web portal for client results review and test ordering; and
  • functionality supporting ISO/IEC 17025, NELAC, ORELAP, ELAP, and Patient Focused Certification (PFC) compliance.


3.4 Data privacy and management

3.4.1 Across the broad cannabis industry

In the fall of 2018, Canada legalized the purchase, growth, and consumption of marijuana in small amounts across the country.[22] Ahead of and after the official date of legalization, concerns were being raised about the protection of Canadian cannabis consumers' personally identifiable information (PII)[23], particularly in regards to data processed and stored in the United States.[24][25][26] In truth, comparisons of Canada's privacy laws with those of the United States existed well before the vote, with resources such as FindLaw detailing risks to any Canadian data transferred to the United States.[27] However, concerns grew that Ontario's mandated use of the e-commerce platform Shopify (until private retail outlets opened in April 2019) would put Canadian cannabis consumers' data at risk.[24][28] In particular, Canadian consumers remain worried that if their purchase history becomes available to United States government officials, who function in an environment of criminalization of cannabis use, they will not be allowed entry into the U.S. at minimum, or be treated as criminals upon attempting entry at worst. As such, some developers of cannabis data management software—such as Cova Software—have publicly acknowledged that any cannabis retail data for Canadian customers will remain in Canada "over and above the current legal requirements."[26] Yet even with data providers' intentions to follow Canadian privacy rules and recommendations, data breaches still occur, as happened with the Canada Post in November 2018.[23][29], further emphasizing the need for strict protocols and protections for cannabis consumer data.

In the United States, despite cannabis' federal prohibition, many states have been taking on various levels of legalization of cannabis. As Rachel Hutchinson of Foley Hoag LLP noted in March 2017, much like Canada, "[l]egalization has led to increased oversight and monitoring, as well as to the collection and storage of personally identifiable information ... [and the] threat of a federal crackdown leaves most customers resistant to creating any sort of paper trail."[30] In this sort of environment, where federal threats still exist, a patchwork collection of state-based laws have sprung up, including Oregon's Senate Bill 863, which prevents retailers of recreational cannabis from collecting and sharing customers' PII.[31] California has also implemented a variation of this type of protection for both recreational and medical cannabis consumers.[32] Of note is California's classification of medical marijuana identification cards as "medical information," which lends additional credence to the idea that medical marijuana consumers' PII held in dispensaries should be protected by U.S. Health Insurance Portability and Accountability Act (HIPAA) regulations.[33] However, without a unified policy and legal framework for cannabis use and its associated data, its difficult to foresee what future data collection and privacy regulations will look like in the United States. Despite this, some software development companies are betting on further demand for privacy of PII with the development of "personal privacy and HIPAA complaint cannabis consumer transaction solution[s]."[34]

Additionally, like Canada, concerns still abound concerning data privacy in the United States. Companies such as THSuite, LLC have already been found to inadvertently expose sensitive personal data—and possibly even protected health information (PHI)—from multiple U.S. cannabis dispensaries, potentially violating HIPAA regulations.[35][36] As the anonymous author of the original report concerning THSuite points out, "most legal experts agree that dispensaries must follow HIPAA regulations just like any other health care provider," and even in a realm without legal risk, exposed data could mean "individuals may suffer backlash if their families, friends, and colleagues find out that they use cannabis."[35] Again, these issues firmly fall at the feet of the main problem of not having unified cannabis legislation, let alone not having a federally recognized legalized status of cannabis. With the unclear and mismatched state of law regarding cannabis user data protection, the onus still remain firmly with software developers and business' data managers in regards to thoroughly testing software and implementing (as well as enforcing) stricter controls such as encryption, intrusion detection, and authentication mechanisms.[36]

3.4.2 What this means for the lab

Logo der ISO.svg

While many cannabis testing laboratories won't be handling medical marijuana patient information, let alone dispensary sales information, lab managers must consider the data privacy issues of those realms and relate them to the data and workflows of the cannabis testing lab. What data must be protected? What standards must be followed to ensure that data's protection?

Take for example ISO/IEC 17025:2017, item 8.4.2, which requires a lab to have "controls" in place "for the identification, storage, protection, back-up, archive, retrieval, retention time, and disposal of its records."[37] The long-term implication here is that data should be clearly identified, securely stored, backed up and archived, and have clear information about their retention and disposal. The data should be thoughtfully "controlled" so it doesn't get lost or fall into the wrong people's hands. This is further evidenced by ISO/IEC 17025:2017, item 7.11.3, which calls for the data to be "protected from unauthorized access" and "safeguarded against tampering and loss."[38]

As such, it's obvious that cannabis testing labs, at a minimum, have to take data privacy and management seriously to stay in step with the ISO/IEC 17025 standard. That of course doesn't take into consideration any regulatory requirements for chain of custody and certificates of authority to be preserved by the lab for a specific period of time, nor does it account for any proprietary methods and business details that could potentially harm a lab in the wrong hands. Just like the personal health information of medical marijuana patients, and like the customer information of dispensaries, cannabis testing labs are charged with ensuring the security and privacy of the data they collect and manage.

To meet those requirements and more, a LIMS that includes functionality that helps labs support ISO/IEC 17025:2017, NELAC, ELAP, and Patient Focused Certification (PFC) requirements makes for a wise investment. Cannabis testing workflows can be difficult, as is the management of associated analytical instruments and their data. Throw in the complication of a semi-fractured regulatory atmosphere, and the cannabis testing lab is forced to operate with tight, enforced procedures to ensure not only the quality of tested cannabis substances but also the chain of custody of samples that come into the lab's possession. A LIMS that can carefully and automatically collect, manage, track, retain, and archive operational data—as well as the audit trails associated with those activities—is required to better maintain the security and privacy of that data, as well as the long-term viability of the lab.[20]

In general, you'll probably want to budget a minimum of roughly $40- to $80,000 minimum (including setup, training, interfaces, etc.) for a decent, bang-for-your-buck professional LIMS, with $300 to $900 per month (depending on number of users) for ongoing subscriptions. At around five concurrent users, the economics start to favor purchasing perpetual licenses rather than paying for a subscription. Purchased licenses will also entail ongoing annual or monthly costs as well (e.g., maintenance, support, warranty for updates etc.) Subscriptions (if available) are generally aimed at smaller labs. If you will be growing and scaling up, it may be a great way to get started, but make sure you have the option to switch to perpetual licenses later.


References

  1. ↑ 1.0 1.1 1.2 1.3 Kaul, S. (3 June 2020). "Managing a Cannabis Lab". Lab Manager. https://www.labmanager.com/business-management/managing-a-cannabis-lab-22822. Retrieved 23 January 2021. 
  2. ↑ 2.0 2.1 2.2 Cannalysis (8 April 2020). "Cannalysis Lab Decreases Processing Time by 94% with Lab Automation Software". Analytical Cannabis. https://www.analyticalcannabis.com/articles/cannalysis-lab-decreases-processing-time-by-94-with-lab-automation-software-312343. Retrieved 23 January 2021. 
  3. ↑ Goldman, S. (January 2021). "Automation in the Cannabis and Hemp Testing Laboratories of Tomorrow". Technology Networks. https://www.technologynetworks.com/tn/webinars/automation-in-the-cannabis-hemp-testing-laboratories-of-tomorrow-344293. Retrieved 23 January 2021. 
  4. ↑ Horne, M.; Mastrianni, K.R.; Amick, G. et al. (2020). "Fast Discrimination of Marijuana using Automated High‐throughput Cannabis Sample Preparation and Analysis by Gas Chromatography–Mass Spectrometry". Journal of Forensic Sciences 65 (5): 1709–15. doi:10.1111/1556-4029.14525. 
  5. ↑ Modern Canna Labs (29 September 2020). "Importance of LIMS in Hemp Testing Laboratories". https://www.moderncanna.com/cannabis-testing/importance-of-lims-in-hemp-testing-laboratories/. Retrieved 23 January 2021. 
  6. ↑ Apte, A. (27 March 2019). "The Role of LIMS in Achieving ISO 17025 Compliance in Cannabis Testing Laboratories". LabRoots. https://www.labroots.com/webinar/role-lims-achieving-iso-17025-compliance-cannabis-testing-laboratories. Retrieved 23 January 2021. 
  7. ↑ Gibbon, G.A. (1996). "A brief history of LIMS". Laboratory Automation and Information Management 32 (1): 1–5. doi:10.1016/1381-141X(95)00024-K. 
  8. ↑ McLelland, A. (1998). "What is a LIMS - a laboratory toy, or a critical IT component?" (PDF). Royal Society of Chemistry. p. 1. Archived from the original on 04 October 2013. https://web.archive.org/web/20131004232754/http://www.rsc.org/pdf/andiv/tech.pdf. Retrieved 23 January 2021. 
  9. ↑ Kyobe, S.; Musinguzi, H.; Lwanga, N. et al. (2017). "Selecting a Laboratory Information Management System for Biorepositories in Low- and Middle-Income Countries: The H3Africa Experience and Lessons Learned". Biopreservation and Biobanking 15 (2): 112–15. doi:10.1089/bio.2017.0006. 
  10. ↑ Department of Revenue, Marijuana Enforcement Division. CCR 212-1 "Medical Marijuana Rules - 1 CCR 212-1". Colorado Secretary of State. https://www.sos.state.co.us/CCR/GenerateRulePdf.do?ruleVersionId=7094&fileName=1 CCR 212-1. Retrieved 22 January 2021. 
  11. ↑ Picó, Y. (2020). "Chromatography–mass spectrometry: Recent evolution and current trends in environmental science". Current Opinion in Environmental Science & Health 18: 47–53. doi:10.1016/j.coesh.2020.07.002. 
  12. ↑ Schieber, A. (2008). "Chapter 1: Introduction to Food Authentication". In Sun, D.-W.. Modern Techniques for Food Authentication. Elsevier. pp. 1–17. ISBN 9780123740854. 
  13. ↑ 13.0 13.1 Rasheed, D.M.; Serag, A.; Shakour, Z.T.A. et al. (2021). "Novel trends and applications of multidimensional chromatography in the analysis of food, cosmetics and medicine bearing essential oils". Talanta 223 (1): 121710. doi:10.1016/j.talanta.2020.121710. 
  14. ↑ Lipp, M.; Shilito, R.; Giroux, R. et al.. "Polymerase chain reaction technology as analytical tool in agricultural biotechnology". Journal of AOAC International 88 (1): 136–55. PMID 15759736. 
  15. ↑ Wacoo, A.P.; Wendiro, D.; Vuzi, P.C. et al. (2014). "Methods for Detection of Aflatoxins in Agricultural Food Crops". Journal of Applied Chemistry 2014: 706291. doi:10.1155/2014/706291. 
  16. ↑ Jannat, B.; Ghorbani, K.; Shafieynan, H. et al. (2018). "Gelatin speciation using real-time PCR and analysis of mass spectrometry-based proteomics datasets". Food Control 87: 79–87. doi:10.1016/j.foodcont.2017.12.006. 
  17. ↑ Khanmohammadi, M.; Garmarudi, A.B.; de la Guardia, M. (2012). "Characterization of petroleum-based products by infrared spectroscopy and chemometrics". TrAC Trends in Analytical Chemistry 35: 135–49. doi:10.1016/j.trac.2011.12.006. 
  18. ↑ Imam, A.; Suman, S.K.; Ghosh, D. et al. (2019). "Analytical approaches used in monitoring the bioremediation of hydrocarbons in petroleum-contaminated soil and sludge". TrAC Trends in Analytical Chemistry 118: 50–64. doi:10.1016/j.trac.2019.05.023. 
  19. ↑ 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 23 January 2021. 
  20. ↑ 20.0 20.1 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 23 January 2021. 
  21. ↑ 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 23 January 2021. 
  22. ↑ Porter, C. (11 November 2018). "Canada’s Message to Teenagers: Marijuana Is Legal Now. Please Don’t Smoke It". The New York Times. The New York Times Company. https://www.nytimes.com/2018/11/11/world/canada/marijuana-legalization-teenagers.html. Retrieved 08 July 2022. 
  23. ↑ 23.0 23.1 Stoller, D.R. (18 November 2018). "Legal Canadian Pot Sales Spur Data Privacy Concerns". Bloomberg BNA. Archived from the original on 02 January 2019. https://web.archive.org/web/20190102164241/https://www.bna.com/legal-canadian-pot-n57982093971/. Retrieved 08 July 2022. 
  24. ↑ 24.0 24.1 Blinch, M. (27 August 2018). "How privatized cannabis sales threaten your privacy". The Conversation. https://theconversation.com/how-privatized-cannabis-sales-threaten-your-privacy-101870. Retrieved 08 July 2022. 
  25. ↑ "A society in transition, an industry ready to bloom: 2018 Cannabis Report" (PDF). Deloitte LLP. 2018. https://www2.deloitte.com/content/dam/Deloitte/ca/Documents/consulting/ca-cannabis-2018-report-en.PDF. Retrieved 08 July 2022. 
  26. ↑ 26.0 26.1 Moore, B. (27 September 2018). "Cova Software Announces Plan to Retain Retail Cannabis Data in Canada". NCIA News. National Cannabis Industry Association. https://thecannabisindustry.org/member_news/cova-software-announces-plan-to-retain-retail-cannabis-data-in-canada/. Retrieved 08 July 2022. 
  27. ↑ "Canada's Privacy Laws vs. the USA PATRIOT ACT". FindLaw. Thomson Reuters. 2 March 2018. https://corporate.findlaw.com/law-library/canada-s-privacy-laws-vs-the-usa-patriot-act.html. Retrieved 08 July 2022. 
  28. ↑ Abraham, E. (18 October 2018). "Cannabis may be legal in Canada – but this is why it's still not safe to buy it online". Independent. https://www.independent.co.uk/voices/cannabis-canada-legal-sale-buying-online-risks-a8589716.html. Retrieved 08 July 2022. 
  29. ↑ Perkel, C. (7 November 2018). "Canada Post admits cannabis privacy breach involving 4,500 Ontario customers". CTV News. https://www.ctvnews.ca/canada/canada-post-admits-cannabis-privacy-breach-involving-4-500-ontario-customers-1.4167149. Retrieved 08 July 2022. 
  30. ↑ Hutchinson, R. (22 March 2017). "Marijuana and Privacy: A Primer". Security, Privacy and the Law. Foley Hoag LLP. https://www.securityprivacyandthelaw.com/2017/03/marijuana-and-privacy-a-primer/. Retrieved 08 July 2022. 
  31. ↑ Marum, A. (19 April 2017). "Smoke pot in Oregon? Your name now protected from feds". The Oregonian. https://www.oregonlive.com/marijuana/2017/04/marijuana_user_data_protected.html. Retrieved 08 July 2022. 
  32. ↑ Sherry, K. (4 October 2018). "Client Alert: New California Privacy Law, AB-2402, Specifically Targets Cannabis Licensees". Nelson Hardiman Newsroom. Nelson Hardiman LLP. https://www.nelsonhardiman.com/client-alert-new-california-privacy-law-ab-2402-specifically-targets-cannabis-licensees/. Retrieved 08 July 2022. 
  33. ↑ Drolet, M. (15 May 2017). "Cannabis and privacy compliance: Is your health information protected?". Cannabis Business Executive. https://www.cannabisbusinessexecutive.com/2017/05/hippa-cannabis-and-privacy-compliance/. Retrieved 08 July 2022. 
  34. ↑ "USMJ and Landstar Plan to Bring Data Privacy and HIPAA Compliance to Marijuana Consumers". PR Newswire. 14 November 2018. https://www.prnewswire.com/news-releases/usmj-and-landstar-plan-to-bring-data-privacy-and-hipaa-compliance-to-marijuana-consumers-831506836.html. Retrieved 08 July 2022. 
  35. ↑ 35.0 35.1 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. 
  36. ↑ 36.0 36.1 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 08 July 2022. 
  37. ↑ Kramer, M. (20 April 2020). "ISO/IEC 17025:2017 Requirements Concerning Document Control and Control of Records" (PDF). Perry Johnson Laboratory Accreditation, Inc. https://www.pjlabs.com/downloads/webinar_slides/4.20.2020_Doc-Control-Records.pdf. Retrieved 13 January 2021. 
  38. ↑ "ISO/IEC 17025:2017: General requirements for the competence of testing and calibration laboratories" (PDF). Shimadzu Europa. https://www.shimadzu.eu/sites/shimadzu.seg/files/SEG/Landingpages/DataIntegrity/SEG_4547_Whitepaper_ISO_v7_OK.pdf. Retrieved 13 January 2021. 
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Citation information for this chapter

Chapter: 3. LIMS, informatics, and cannabis testing

Edition: Winter 2020

Title: LIMS Buyer’s Guide for Cannabis Testing Laboratories

Author for citation: Shawn E. Douglas, Alan Vaughan

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