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'''Title''': ''Starting a Cannabis Testing Laboratory''
'''Edition''': First
'''Authors for citation''': Shawn E. Douglas, Alan Vaughan
'''Notes''': Significant portions of the subsection "The business plan" is adapted from Alan Vaughan's ''Starting a Cannabis Testing Lab'' [https://www.lablynxpress.com/index.php?title=Starting_a_Cannabis_Testing_Lab on LabLynx Press].
'''License for content''': [https://creativecommons.org/licenses/by-nc-sa/4.0/ Attribution-NonCommercial-ShareAlike 4.0 International]
'''Publication date''': June 2019
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=Starting a ''Cannabis'' Testing Laboratory=
==LIMS functionality requirements specific to cannabis testing==
In 2019, the [[cannabis industry]] finds itself unquestionably maturing from the wild and unregulated initial frontier stage of new, uncharted territory, into a more clearly-defined, valid business ecosystem. Searching business-related social media like LinkedIn or LIMSforum, as well as online job sites like Indeed or GlassDoor, will attest to the great number of industry-related organizations, products, and services, including [[laboratory]] testing. And although testing has yet to become mandatory in every state with ''[[Cannabis]]'' laws on the books, the trend is definitely moving in that direction, for both medicinal and recreational products.<ref name="SabolTheFuture18">{{cite web |url=https://www.analyticalcannabis.com/articles/the-future-of-cannabis-testing-311209 |title=The Future of Cannabis Testing |author=Sabol, J.E. |work=Analytical Cannabis |date=30 October 2018 |accessdate=13 June 2019}}</ref> (Even Arizona has finally made potency and purity testing mandatory.<ref name="DownsArizona19">{{cite web |url=https://www.leafly.com/news/politics/arizona-medical-marijuana-fees-lowered-testing-added |title=Arizona Just Made Cannabis Safer and Saved Every Patient $150 |author=Downs, D. |work=Leafly |date=10 June 2019 |accessdate=13 June 2019}}</ref>) {{As of|June 2019}}, nearly 200 unique businesses are operating ''Cannabis'' testing labs across the United States and Canada<ref name="DouglasPast18">{{cite web |url=https://www.limswiki.org/index.php/LII:Past,_Present,_and_Future_of_Cannabis_Laboratory_Testing_and_Regulation_in_the_United_States/Final_thoughts_and_resources |title=6. Final thoughts and 7. Resources |work=Past, Present, and Future of Cannabis Laboratory Testing and Regulation in the United States |author=Douglas, S. |date=May 2019 |accessdate=13 June 2019}}</ref>, offering services that range from extraction only, to full analysis (either production QA/QC or commercial), to research. However, it is clear that more will be required as various valid medicinal properties are documented, general usage proliferates, and testing regulations expand.<ref name="SchroyerIndustry16">{{cite web |url=https://mjbizmagazine.com/industry-snapshot-testing-labs |title=Industry Snapshot: Testing Labs - Data, Trends and Challenges |work=Marijuana Business Magazine |author=Schroyer, J. |date=January 2016 |accessdate=13 June 2019}}</ref><ref name="PeñaCali18">{{cite web |url=https://mjbizdaily.com/california-marijuana-phase-3-testing-costs/ |title=California marijuana industry braces for ‘another enormous burden’ from next phase of testing costs |author=Peña, J. |work=Marijuana Business Daily |date=20 December 2018 |accessdate=13 June 2019}}</ref>
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.
 
As such, the question many lab professionals, investors, and entrepreneurs are beginning to ask is "what's the best way to get started in ''Cannabis'' testing?".
 
==What all do you need?==
Before you do anything, the best approach is to take a close look at the industry, its players, and how you see your lab integrating with the regulatory dynamics of your state. Do you want to test only medicinal cannabis? Recreational? Both? Extraction only? Who are your customers? Can they afford to pay for the testing you want to provide? What are state and national regulations affect your decisions? Are changes to regulations coming soon? How much will a certification like ISO 17025 help? The answers to these and other questions will help you visualize the market and decide whether this is something you really want to do. Additionally, these questions act as fuel for defining the strategic considerations of what should turn into a vital first step: making your business plan.
 
===The business plan===
As with any business proposition, it is important to create a business plan that outlines your goals, how you intend to reach them, and what ongoing business operations are intended to look like. A business plan is commonly viewed as a means to acquire a loan or investment; however, even if you already have all the capital you need, a business plan is supremely useful. The creation process provides a valuable opportunity to visualize and clarify the necessary components before approaching others for investment or any other kind of participation. It can also continue to be useful for the life of your business, helping you stay on track. As you learn new concepts and gain additional experience, the business plan can then be updated to further improve your laboratory operations. Templates to help you begin are available from a number of sources, including free plan builders via the U.S. Small Business Administration<ref name="SBABuild">{{cite web |url=https://www.sba.gov/tools/business-plan/1 |title=Build Your Business Plan |publisher=U.S. Small Business Administration |accessdate=14 June 2019}}</ref> and Palo Alto Software<ref name="Fargo">{{cite web |url=https://www.bplans.com/laboratory_business_plan/executive_summary_fc.php |title=Fargo Medical Laboratories Laboratory Business Plan |work=Bplans.com |publisher=Palo Alto Software, Inc |accessdate=20 June 2019}}</ref>, as well as a proprietary ''Cannabis'' testing laboratory business plan template via Spathium Limited.<ref name="SpathiumCanna">{{cite web |url=https://cannabusinessplans.com/cannabis-testing-laboratory-business-plan/ |title=Cannabis testing laboratory business plan |work=Cannabis Business Plan |publisher=Spathium Limited |accessdate=14 June 2019}}</ref>
 
Standard components of a business plan include:
 
* executive summary
* general company description
* scope of business
** products and services
* strategic considerations
* marketing plan
* operational plan
* management and organizational structure
* financial statements and projections
** startup expenses and capitalization
 
====Executive summary====
In the executive summary, you lay out your whole vision in simple, clear terms. Some advise you to wait and make this the last section you complete so that you have a clearer understanding of the whole picture. For most of us, though, it's helpful to at least start with the laboratory's mission or vision as you understand it. Afterwards, read it back and ask yourself if it still sounds like a genuine and actionable idea. If it does, then move on. Once you've finished all of the other sections, you will in want to circle back and adjust this section based on any epiphanies or aspects of the plan that perhaps you hadn't fully thought through initially. You'll also want to include who your target market is and provide a summary of what initial start-up of the business would look like. If you're looking for funds or other support, then this is also the place to describe that effort, as many who you approach may only really read this section, at least initially, to determine whether the plan is worth further consideration.
 
====General company description====
What will your laboratory and overall business optimally look like? This section lets you communicate how you envision your laboratory business unfolding. A mission statement, philosophy, goals, values: these really define the "soul" of the company, and you can set these out here. Additionally, a fuller description of the industry and your place in it, how it all works organically, what you bring to the table, and how you see it all progressing over time all combine to give the reader—and you—a more gut-level understanding of just what your proposed lab is all about. You should also include the legal forms it will take, e.g., business entity set-up, state licensing, certifications, etc.
 
====Scope of business====
[[File:Canna Lab Pic Facing Left.png|right|400 px]]This section describes the core of your laboratory business. What testing will you provide, in what manner, and for whom?
 
''Cannabis'' analysis has, with time, started to distill down to well-defined testing methods, standards, and instrumentation. Common attributes tested include potency (with accuracy tolerances mandated in some cases by the state) and terpenoid/balance analysis that validate product types, as well as pesticide, residual solvent, and mold/fungus testing. In most cases, the entire range will probably need to be tested since potency and safety are important aspects regardless of being medicinal or recreational ''Cannabis''. Increasingly, the most successful testing labs are the ones that can effectively guarantee those factors and deliver certificates of analysis (COA) at the most competitive price and speediest turnaround, all while presenting a friendly and attractive, yet professional and authoritative image.
 
Customer-facing web portals are becoming the standard, and pickup and delivery of samples is another increasingly attractive service to customers, especially as most markets are no bigger than statewide, with many based at the municipal level. But as laws change, scalability should always be at the forefront.
 
Another point to note is diversification. The lab that is equipped to test ''Cannabis'' is equipped to test other things as well, so why limit yourself? Even though you may position yourself as primarily a ''Cannabis'' lab, there is risk reduction in offering your services in similar areas as well. For example, many of the tests involved in ''Cannabis'' testing (pesticides, mold/fungus, microbiology) are also common in agriculture, food and beverage, and environmental testing. Why not branch out and invite other types of customers as well? Of course there is overlap already, obviously in the area of edibles. But the more diversification you can provide, the more built-in protection you have against market forces, as long as the cost in time, effort, and expense of those additional services doesn't outweigh the benefits.
 
With laboratory testing also comes the associated data management. Depending on the type of testing you plan on performing, as well as the anticipated workload and regulations involved, investment in a data management system such as a [[laboratory information management system]] (LIMS) will be a scope consideration. There are, for instance, some cheap or even free cannabis LIMS available. However, given that specific and rigorously enforced regulations inevitably accompany legalization, labs are unwilling to risk their sizable investment on anything less than a fully-compliant solution. It may also be wise to select something that is flexible and easy to modify as regulations and standards—and demands of the industry itself—evolve and mature.
 
====Strategic considerations====
It's all well and good to decide you want to deliver analytical laboratory services to the ''Cannabis'' industry, but there's more to consider if you truly want to be successful. The strategic considerations section allows you to identify and address the critical elements of your strategy necessary to succeed. Ask yourself questions like:
 
* What will my competitive advantages be?
* What relationships or potential partnerships should I consider? Growers, dispensaries, collection/delivery services, extraction labs, subcontract labs...
* Where should I locate my lab?
* What kind of volume am I looking at?
* Are there existing competitors? How are they doing? Can I learn from them?
* What is the regulatory landscape and how is it likely to change?


The answers to these and similar questions can prepare you for the realities of the operation you will encounter. Martin Zwilling, experienced entrepreneur and investor, provides additional advice to those planning startups:
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?


<blockquote>Accept uncertainty as the norm. You will never remove all uncertainties, so accept them, and plan your activities in an incremental fashion. Too often, a business plan is seen as a mechanism for eliminating uncertainty, lulling the founder into complacency. Eliminate major uncertainties before the plan and update any plan as you learn.<ref name="Zwilling10Reasons13">{{cite web |url=https://www.entrepreneur.com/article/229804 |title=10 Reasons Not to Write a Business Plan |author=Zwilling, M. |publisher=Entrepreneur, Inc |date=06 November 2013 |accessdate=14 June 2019}}</ref></blockquote>
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.
===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.


====Marketing plan====
'''Relevant LIMSpec''':
Your marketing plan includes two key elements: research and dissemination.
* 1.11 The system should support the creation of user-definable default sample registration input screens and/or preferences.


When it comes to research, you can conduct primary and secondary types of research. While this article and other resources like industry magazines, groups and communities, and blogs can provide great insight and information about the industry, you should also do your own primary research (research you conduct yourself of have performed for you, gathering information directly from a source).<ref name="TheHartfordMarket">{{cite web |url=https://www.thehartford.com/business-playbook/in-depth/business-primary-second-research |title=New Business Marketing - Market Research: The Basics |work=Business Owner's Playbook |author=The Hartford |accessdate=14 June 2019}}</ref> Meet with people in the industry, talk to competitors, potential customers, producers, and industry advocates. Check with those who failed or moved to other markets. What happened? What are the economics of the industry, e.g., size of the market, your predicted share, trends, growth, etc.? Is there a genuine opportunity, a need for what you will provide? Who are your competitors? Will your pricing be competitive?
'''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.


Next, devise your marketing strategies to get the word out about your product/service and keep them in the spotlight. This includes designating how much of your overall budget you need to and are willing to apportion. It also includes your strategic thought processes that, when implemented well, will ensure that your investment yields the most effective results in the most efficient manner. Additionally, you'll also want to communicate the particular qualities that comprise your uniqueness and competitive edge.


Today's marketing strategies are heavily internet-based, which can allow for cost-effective, impactful results that were unimaginable in yesterday's traditional advertising models. However, despite the benefits of internet marketing, there is never a substitute for the power of positive word-of-mouth. Indeed, successful sites such as Amazon and eBay, and many others, recognize this fact well, providing customer star ratings and feedback for all of their products, a more modern version of word-of-mouth with similar traditional value. Building a good reputation is a long, hard process. Tearing it down is easy and quick. That is a place where your core values and principles, as expressed in the "general company description" section, have a real impact, along with your actual performance. But the old-fashioned satisfied customer who speaks well of you to others is still one of your most precious assets.
===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.


====Operational plan====
'''Relevant LIMSpec''':
Your operational plan constitutes the nuts and bolts of your overall success. This is where the visions for your business meets reality from an operational standpoint. You need to outline exactly how things will work on a daily basis, from receiving to reporting; what software, hardware, processes, staff, and other resources are involved; and how they are all implemented, with specifications and detailed descriptions. You'll want to take following into account when drafting your operational strategy:
* 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.


''Location''<ref name="EverettCanna19">{{cite web |url=https://www.labmanager.com/business-management/2019/05/cannabis-lab-design |title=Cannabis Lab Design |author=Everett, L. |work=Lab Manager |date=03 May 2019 |accessdate=20 June 2019}}</ref>:
'''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.
* infrastructure requirements
* furniture design and logistics
* long-term production planning
* non-testing equipment: hardware, communication systems


''Human resources''<ref name="StitesHuman15">{{cite web |url=https://tek-dev.typepad.com/technology-development/2015/02/human-resource-management-in-the-laboratory.html |title=Human Resource Management in the Laboratory |author=Stites, R. |work=Technology Development |date=26 February 2015 |accessdate=14 June 2019}}</ref>:
* client services
* staffing practices
** number of employees
** labor type and roles
** staff quality and competency
** pay structure
** training methods and requirements
** relevant job descriptions


''Testing techniques and costs''<ref name="EverettCanna19" /><ref name="AndersonCanna18">{{cite web |url=https://cannabis.gentechscientific.com/cannabis-testing-lab-setup |title=Cannabis Testing Lab Setup |author=Anderson, D. |publisher=GenTech Scientific |date=April 2018 |accessdate=June 2019}}</ref>:
===Creation and management of additional protocols, labels, and analytical reports===
* instruments and equipment
'''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.
* submission process
* testing processes
* reporting processes


''Quality control/assurance''<ref name="ACWDQuality15">{{cite web |url=https://www.acwd.org/DocumentCenter/View/989/Quality-Assurance-and-Quality-Control-Officer?bidId= |title=Quality Assurance/Quality Control Officer |publisher=ACWD |date=April 2015 |accessdate=14 June 2019}}</ref>:
'''Relevant LIMSpec''':  
* accreditation management
* 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.
* compliance reporting
* 1.6 The system shall allow for the addition, modification, and removal of new, pre-defined, and custom analytical tests.
* competency standards and training protocols
* 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.
* detection limits and action levels
* 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.
* safety and cleanliness management<ref name="EverettCanna19" />
* 32.9 The system shall support configurable laboratory workflows based on appropriate laboratory process and procedure.


''Legal requirements''<ref name="StaggsState18">{{cite web |url=http://www.thecannifornian.com/cannabis-news/california-news/state-gives-marijuana-businesses-time-get-licensed-comply-new-regulations/ |title=State gives marijuana businesses more time to get licensed, comply with new regulations |author=Staggs, B.E. |work=The Cannifornian |date=30 April 2018 |accessdate=20 June 2019}}</ref>:
'''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.
* licensing and bonding
* permits
* health, workplace, or environmental regulations
* state, local, and any applicable federal regulations specifically regarding ''Cannabis''
* zoning or building code requirements
* insurance coverage<ref name="RLGSelect18">{{cite web |url=https://www.rogowaylaw.com/insurance-cannabis-companies/ |title=Selecting The Right Insurance For Your Cannabis Business |author=Rogoway Law Group |publisher=Rogoway Law Group |date=15 June 2018 |accessdate=20 June 2019}}</ref>
* trademarks, copyrights, or patents (pending, existing, or purchased; note: until federal laws change, cannabis-related brands cannot be trademarked)


''Inventory and purchasing'':
===Flexible specification limit sets===
* operating levels
'''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.
* stocks, standards, and reagents suppliers
* credit and delivery policies
* managing storage conditions and expiration
* software application (often available as part of LIMS functionality)


''Financial management'':
'''Relevant LIMSpec''':
* credit and payment policy
* 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.
* accounts receivable: net, aging tracking, collection policies
* 32.2 The system shall allow authorized users to configure the specification limits for sample and instrument tests.
* accounts payable: recurring, one-time, aging, discounts
* choosing a billing service or software-based billing


''Administrative functions'':
'''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>
* who will be responsible (internal or external management)
* periodic update to business plan
* evaluate need for new services or programs
* standard operating procedures development
* continuity of operations planning<ref name="ASPRTRACIELab18">{{cite web |url=https://files.asprtracie.hhs.gov/documents/aspr-tracie-ta--laboratory-coop-plans-508.pdf |title=Laboratory Continuity of Operations Plans |author=ASPR TRACIE |publisher=HHS.gov |date=01 May 2018 |accessdate=14 June 2019}}</ref>


''IT and data management'':
* software application selection and management
* hardware selection and management (IT infrastructure or cloud-based)
* regulatory requirements for data management and reporting


Mentioned at the start, location is an important aspect of your operational plan that warrants further discussion. The design and logistics concerning the laboratory premises of the premises requires extra consideration because you will presumably be contending that space for a long time. First, make sure you set up zones that make sense so that all of the processes for each type of testing can be done largely within a single zone. Or, if not that, consider keeping all weighing, labeling, and other prep in one zone, all gas chromatography testing in another, etc., but arranged so that the process flow is supported. And give workers sufficient access to instruments and workspace. Keep commonly used large equipment away from heavy traffic areas yet still easily accessible.
===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.  


Second, you'll want to focus on cleanliness and safety. Keep any messy or hazardous areas away from main traffic areas, and keep critical areas such as lab surfaces and sinks clean. You'll also want to keep biosafety (if you are doing microbiology, for instance) and good laboratory practice (GLP) in mind.<ref name="HadesStarting18">{{cite web |url=http://bitesizebio.com/30527/starting-new-lab |title=Starting Up a New Lab: What you Need to Know |author=Hades, Z. |work=BitesizeBio |date=07 October 2018 |accessdate=14 June 2019}}</ref> Lab entry should be restricted to authorized personnel to minimize risk. There should be more than one exit from the lab in case of emergencies. Install fire extinguishers, fire blankets, emergency showers (with an easy to reach handle), and keep safety gloves in-stock.
'''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.


====Management and organizational structure====
'''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.
[[File:Lab Organizational Chart.jpg|frame|right|Example organizational chart]]You may have noticed the operational requirement of knowing "who will be responsible" in the prior section. Indeed, you'll have to decide whether you intend to spend your time managing or performing analyses, or even concentrating more on promotion, marketing, and connecting with others in the industry. Or maybe you prefer to dabble in all these activities, with people already in those designated roles so that you pop in randomly to ensure things are running as they should. Whatever your intended role and organizational setup, you'll need to specify it all here. If your staff will number 10 or more, it's a good idea to draw up a hierarchical flowchart-style organizational diagram to make it clear how decision-making and task flows take place. Additionally, if you plan on having any advisers, consultants, or board members, then elaborate on those roles in this section, including attorneys, accountants, insurance agents, bankers, and mentors.


====Financial statements, projections, and startup capital====
First, what you and any partners, stockholders, or investors bring to the table should be presented here as a personal financial statement, shown in a balance sheet format that lists both assets and liabilities. This need not be made available to everyone who sees the plan. It can be on an "available upon request" basis for only those parties for whom it is a necessary component (bank, additional investors). A high-level view of this is, however, part of your executive summary.


As for the financial projections based on those statements and other particulars, you'll need to develop a sturdy financial plan. Creating a realistic financial plan with accurate data (where they are known) and sticking to (or going under) its budget is crucial for your project to be successful. Even then, unforeseen economic or business factors may emerge and threaten its fulfillment.
===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.


Some elements of a good financial plan include:
'''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.


:1. ''Important assumptions'': Here you'll include current interest rates and sensible predictions of their likely changes over time, tax rate projections, market and other business factor projections, etc. All need to be considered and factored in as assumptions that impact the projected financial performance of your lab.
'''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.


:[[File:Business Plan - General Assumptions Table.png]]


:Additionally, you'll want to conduct a break-even analysis, which takes monthly income and expenses into account to calculate the monthly income needed to both break even and become profitable.
===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).


:2. ''Business ratios'': Business ratios are a measure of the company's actual net worth at any given point in time, essentially a snapshot of its financial health. Like your personal financial statement, it shows the ratio between your company's liabilities and assets. However, in this context it plots the predicted ratio over several years and also compares it to overall industry averages.
'''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.


:3. ''Projected profit and loss'': Your monthly projection of profit and loss provides a useful guideline both for initial planning and for maintaining adherence to the plan month by month. If you start to see significant deviation—and not in a good way—then you can make adjustments in real time before things get too far out of control. Include an annual projection for a higher-level view showing the emergence from deficit operations to profitable business operations.
'''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.


:Additionally, weekly projections will help you identify problems even earlier and make necessary adjustments well before they are seen in the monthly numbers. Any additional profit/loss projection tools will all add to the risk management of your lab project.


:4. ''Projected cash flow'': Having cash on hand, available for emergencies or just unforeseen contingencies, is as important as meeting your profit/loss predictions. Businesses have been forced to shut down because they were operating too close to full cashflow while dealing with unanticipated expenses. The ongoing cash flow becomes more important over time as initial capital is expended. Incoming revenue, therefore, must make up the difference in maintaining a healthy buffer. As with all projections and actual records, it is important to make sure you have included everything that applies, including asset depreciation, interest, etc.
===Inventory reconciliation===
'''Cannabis testing LIMS requirement''': The system should support inventory reconciliation, including sample weight reconciliation, while limiting data entry errors.


:5. ''Opening day balance sheet'': Your opening day balance sheet provides the baseline for tracking your profitability and net worth going forward. The reality of it may be a little different than what you had predicted in your startup expenses and required capital balance sheet, but it's important that this one reflects reality.
'''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.


:6. ''Projected balance sheet'': Along with the profit/loss and cashflow projections, a projected balance sheet broken down by year provides another perspective to help gain a comprehensive view of what your financial plan predicts. Like the business ratios, it provides annual snapshots of predicted net worth and shows when that is projected to become positive.
'''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...


Finally, you'll need to address startup expenses and required capital. Obviously, starting any laboratory requires capital, in the form of premises, equipment, qualified staff and/or the money to acquire them. Your personal financial statement brings into focus what you are able to invest in the project. This section catalogs every facet of your startup costs, from any licensing, legal fees, etc. to your instruments, property costs, stocks, and the like, down to the last sample container. As you may imagine, getting this right is one of the more critical—and expensive—parts of your business plan.


You are the best judge of what equipment and stock you will need, based on your own experience and training. Getting used equipment where possible can save some expense, as long as it's in good condition and is likely to last until you are able to upgrade. You can use the "operational plan" section to help you list the items you'll need to make that happen. You may need to categorize items as "essential" vs, "nice to have." Even the essentials can be phased in to ease up cost flow, as you can start out doing limited testing and expand as income allows.<ref name="Fargo" />
===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.


Traditionally, it is more costly for a startup lab to lease commercial space with existing lab facilities than it is to establish a lab in an incubator facility.<ref name="Genovesi">{{cite web |url=http://www.labmanager.com/business-management/2015/04/secrets-of-a-successful-start-up-lab |title=Secrets of a Successful Start-Up Lab |author=Genovesi, L. |work=Lab Manager |date=01 May 2015 |accessdate=20 June 2019}}</ref>
'''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.


As for "required capital," include operating expenses for the first year or reasonable period while income is uncertain, with enough reserve to cover any issues arising. These can be derived from the projections in your financial plan.
'''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.


===Purchasing tips===
Here are some purchasing tips from others who have gone through the lab startup process<ref name="ChemBark">{{cite web |url=http://blog.chembark.com/2013/04/09/starting-up-a-chemistry-lab-advice-bargains/ |title=Starting Up a Chemistry Lab: Advice & Bargains |author=Bracher, P. |work=ChemBark Blog |date=09 April 2013 |accessdate=20 June 2019}}</ref><ref name="Reddit">{{cite web |url=https://www.reddit.com/r/chemistry/comments/19aui0/tips_for_the_frugal_chemist/ |title=Tips for the frugal chemist? |author=freesky99z  |work=Reddit Chemistry |date=26 February 2013 |accessdate=20 June 2019}}</ref>:


* Safety glasses can vary wildly in price, from around $2 to around $11 or more. Shop around.
===Data security and confidentiality===
* Use less precise balances where tolerances aren't as critical, and save the more accurate one(s) for processes where it matters.
'''Cannabis testing LIMS requirement''': The system should ensure data security and confidentiality for at-rest and in-transit data.
* It's much better to buy tools and routine equipment (e.g., duct tape) at a hardware store than through science vendors.
* Buy in bulk and buy early. Delays happen.
* Some used equipment can be a great bargain. Maybe avoid the used [[liquid chromatography–mass spectrometry]] (LC/MS), but perfectly good rotary evaporators, vacuum ovens, centrifuges, fraction collectors, etc. are readily available. Check out the surplus lab supply companies and call them directly with your wishlist. They have warehouses full of stuff that may or may not be on their websites.
* Ultrasonic cleaners can be found for about a third of the usual price if you buy them from jeweler supply companies.
* Ask for discounts. They are more available than you think and can be up 30 to 40%.
* Check surplus outlets.
* Look out for labs that are closing down.
* eBay, restaurant supply companies (stainless steelware, etc.) and other non-lab sources can save you money on the same items you may use in your lab.
* Sites such as [https://www.labx.com/ labx.com], [https://www.go-dove.com DoveBid] (not so much for used analytical instruments; they can be difficult to get running again), and the [https://www.limsforum.com/marketplace/lab-supplies LIMSforum Marketplace] are resources for both new and used items.
* Watch out for auction houses' fees, and remember you will have to pick up/ship.
* Always buy service contracts for big items.


==What are the financial considerations and available sources for financing?==
'''Relevant LIMSpec''':
** https://terpenesandtesting.com/cannabis-investors/
* 35.1 The system should use secure communication protocols like SSL/TLS over Secure Hypertext Transfer Protocol with 256 bit encryption.
** https://www.begreenlegal.com/why-cannabis-testing-labs-in-california-are-attracting-investors/
* 35.2 The system should support database encryption and be capable of recording the encryption status of the data contained within.
** https://mjnewsnetwork.com/business/casa-verde-capital-leads-investment-in-cannabis-testing-lab-cannalysis/
** https://www.prnewswire.com/news-releases/steep-hill-closes-2-million-investment-round-300455885.html
** https://www.finder.com/cannabis-business-crowdfunding
** https://www.diamondbl.com/marijuana-business-funding
** https://www.greenentrepreneur.com/article/312309
** https://gudcapital.com/cannabis-business-loans-dispensary-financing-and-marijuana-industry-investment/
** https://mjbizdaily.com/cannabis-banking-protections-provided-in-congressional-spending-bill/
** https://www.forbes.com/sites/tomangell/2019/06/02/congressional-funding-bill-protects-cannabis-banking-and-lets-dc-legalize-marijuana-sales/#7ac697931213
** https://www.newcannabisventures.com/cannabis-investors/


==What kind of instrumentation and data management is required?==
'''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.
Before ambitiously running out to buy instrumentation and data management solutions for your ''Cannabis'' testing laboratory, you'll want to consider the various techniques for analytically testing ''Cannabis'' and the associated equipment costs. While consensus testing standards continue to coalesce into preferred techniques, a variety of techniques remain useful for investigating ''Cannabis'' constituents and their concentrations. From using gas chromatography to make determinations about terpenes in a sample to using [[Real-time polymerase chain reaction|quantitative polymerase chain reaction]] (qPCR) techniques to identify [[mycotoxin]]s and [[microorganism]]s, these differing techniques require a wide variety of laboratory tools. The most common among cannabis testing instruments are chromatography and [[spectroscopy]] equipment, often combined together for a more complete analysis. However, this equipment can be expensive, sometimes prohibitively expensive. Initial investments may range anywhere from $75,000 up to $600,000 or more, depending on what sort of testing is being performed in the lab.<ref name="SchroverIndustry16">{{cite web |url=https://mjbizmagazine.com/industry-snapshot-testing-labs/ |title=Industry Snapshot: Testing Labs |author=Schrover, J. |work=Marijuana Business Magazine |date=January 2016 |accessdate=21 June 2019}}</ref><ref name="CliffordCanna18">{{cite web |url=https://www.news-medical.net/news/20180205/Cannabis-Quality-and-Contamination-Testing.aspx |title=Cannabis Quality and Contamination Testing |author=Clifford, B. |work=News Medical Life Sciences |date=05 February 2018 |accessdate=21 June 2019}}</ref><ref name="BorchardtCannabis17">{{cite web |url=https://www.forbes.com/sites/debraborchardt/2017/04/05/cannabis-lab-testing-is-the-industrys-dirty-little-secret/ |title=Cannabis Lab Testing Is The Industry's Dirty Little Secret |author=Borchardt, D. |work=Forbes |date=05 April 2017 |accessdate=21 June 2019}}</ref>  


As such, the previously discussed business plan and its addressing of various aspects such as business scope, startup funding, state testing regulations, and long-term strategy for growth are vital in determining your budget and requirements for instruments and software. Your business plan may see enough demand in your market for simply testing psychoactive potency ([[cannabinoid]] content) in the interim until you raise enough funds to expand your analytical offerings to other areas. Or maybe the lab is well-funded enough to take on analysis of some contaminates such as [[pesticide]]s and mycotoxins from the start, but hold off on the equipment for heavy metals testing due to costs. These considerations and more will largely be based on the kind of instrumentation you want and can afford. In some cases, new labs or labs looking to expand their analytic offerings to ''Cannabis'' testing may consider the purchase of previously owned equipment to save on initial start-up costs.


==What data integrations are vital?==
===Accounting and billing===
At least in the U.S., given the federal status of recreational and medicinal marijuana, labs operating in ''Cannabis''-legal states still have to be particularly mindful of their operations for fear of breaking even a state or local regulation, potentially putting the lab out of business. Samples are tracked internally from receipt to distribution or destruction. However, it's often not enough to keep careful track of the ''Cannabis'' samples that move in and out of the laboratory. This is particularly true in states that mandate track-and-trace (sometimes called "seed-to-sale") monitoring and reporting. In that case, keeping data siloed in the lab isn't an easy option to work with. States mandating the use of a particular track-and-trace software platform means either manually transferring data from the lab's systems—or, worst case, from the lab's paper documentation—to the mandated track-and-trace software. This is where integration between the lab's data management platform and the state's system proves useful.
'''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.


Below are representative examples of the most commonly used track-and-trace software systems that cannabis testing laboratories may need to integrate with:
'''Relevant LIMSpec''':
* Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec.


* '''[https://www.biotrack.com/cannabis-software/ BioTrackTHC]''': As both a track-and-trace system and an enterprise resource planning (ERP) solution, BioTrackTHC streamlines data management and workflows from cultivation and processing to laboratory testing and dispensation. Compliance features include customized reporting to meet government-specific needs, tracking of destruction and waste activities, transport manifests, recall tracking, regulation labels, workflow management, and more. The software has also been adopted by state governments such as Illinois, Hawaii, New Mexico, and New York.<ref name="NelsonASeed17">{{cite web |url=https://www.cannabisbusinesstimes.com/article/a-seed-to-sale-shakeup/ |title=A Seed-to-Sale Shakeup |author=Nelson, S. |work=Cannabis Business Times |date=30 May 2017 |accessdate=21 June 2019}}</ref>
'''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.


* '''[https://leafdatasystems.com/ Leaf Data Systems]''': Similar to BioTrackTHC, Leaf Data Systems is used by both industry operators and government agencies trying to regulate the cannabis industry. The system can manage data at all points along the cannabis lifecycle, from cultivation and processing to distribution, testing, and sale. Leaf can handle customized reporting depending on state or municipality, as well as customizable alerting to ensure enforcement activities are effective. The software has been adopted by the governments of Pennsylvania and Washington.<ref name="WoodMJFree18">{{cite web |url=https://www.inquirer.com/philly/business/cannabis/mjfreeway-series-c-leaf-data-systems-medical-marijuana-cannabis-legalization-batu-cresco-20180920.html |title=MJ Freeway raises $10M to improve marijuana tracking software, expand operations |author=Wood, S. |work=The Inquirer |publisher=Philadelphia Media Network (Digital), LLC  |date=20 September 2018 |accessdate=21 June 2019}}</ref>


* '''[https://www.metrc.com/ Metrc]''': Developed by Franwell, Metrc represents another major solution used by not only businesses in the cannabis supply chain but also state and local governments. Special features include trend analysis, employee activity tracking, credentialing, and process metrics. States using it include California, Colorado, Massachusetts, Montana, and the District of Colombia, among others.<ref name="McVeyChart18">{{cite web |url=https://mjbizdaily.com/chart-dominant-player-emerging-for-state-cannabis-seed-to-sale-tracking-contracts/ |title=Chart: Dominant player emerging for state cannabis seed-to-sale tracking contracts |author=McVey, E. |work=Marijuana Business Daily |date=10 September 2018 |accessdate=21 June 2019}}</ref>
===Secure web portal===
'''Cannabis testing LIMS requirement''': The system should provide a secure web portal for client results review and test ordering.


* '''[https://us.sicpa.com/cannabiscontrol SICPATRACE]''': Perhaps less known in the U.S., the Swiss company SICPA has been involved in security inks and financial security for many decades.<ref name="SICPAHist">{{cite web |url=https://www.sicpa.com/sicpa-history |title=SICPA History |publisher=SICPA Holding SA |accessdate=21 June 2019}}</ref> It introduced its SICPATRACE software in 2007 for governments to better "fight counterfeiting, illicit trade and tax evasion."<ref name="SICPAHist" /> It has since been adopted for regulatory activities involving tobacco, alcohol, and now cannabis. Among its technological features is the use of multi-layer label security that incorporates multiple ways to track and trace products, batches, and samples. In the U.S., SICPATRACE has been adopted by several California counties.<ref name="SICPACalif18">{{cite web |url=https://www.sicpa.com/news/sicpa-announces-calorigin-cannabis-solution-certified-integrate-california-state-system |title=California: CalOrigin Cannabis Solution Certified |publisher=SICPA Holding SA |date=02 May 2018 |accessdate=21 June 2019}}</ref>
'''Relevant LIMSpec''':
* Currently no regulatory- or standard-based requirement for this and thus not in the original LIMSpec.


Also of note is the somewhat new concept of "tag-and-trace," the molecular application of DNA markers in a plant to allow for forensic tracking across the supply chain. Products like ETCH Biotrace may eventually also be part of the integrated chain of software for cannabis testing laboratories.<ref name="EagleRiding18">{{cite web |url=https://www.foodnavigator.com/Article/2018/10/26/TheraCann-expected-to-grow-sales-of-ETCH-Biotrace-thanks-to-growing-demand-for-legalised-cannabis |title='Riding on a high': TheraCann expected to grow sales of ETCH Biotrace thanks to growing demand for legalised cannabis |author=Eagle, J. |work=FoodNavigator.com |date=26 October 2018 |accessdate=02 February 2019}}</ref>
'''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.


===Other integrations===
However, integration isn't limited to just state systems; integration between various software systems and instruments in the laboratory is also vital. The [[chromatography data system]] (CDS) should integrate with the [[laboratory information management system]] (LIMS), for example, just as an autosampler or analytical instrument should be integrated with the LIMS. In the end, the decision to connect laboratory instruments and other data systems together will depend on your compliance requirements for security and data extraction<ref name="StraussConnect18">{{cite web |url=https://www.labmanager.com/laboratory-technology/2018/07/connecting-lab-instruments-interface-strategies-depend-upon-compliance-requirements |title=Connecting Lab Instruments: Interface Strategies Depend Upon Compliance Requirements |author=Strauss, D. |work=Lab Manager |date=09 July 2018 |accessdate=21 June 2019}}</ref>, as well as regulation-mandated data.<ref name="BennettCanna18">{{cite web |url=https://www.leafly.com/news/science-tech/why-test-cannabis |title=Cannabis Testing Explained: What’s in Your Cannabis? |author=Bennett, P. |work=Leafly |date=31 December 2018 |accessdate=21 June 2019}}</ref>


Another software system that may be used internally to manage laboratory operations is an ERP. This type of enterprise software has been used in many industries to help collect, store, manage, and interpret a wide variety of data associated with the management and operations of a business. This may include financial, budgeting, human resources, manufacturing, order management, supply chain management, project management, and customer management activities. The cannabis testing laboratory is no exception with managing these sorts of duties, and while the more competitive LIMS today include many of these capabilities, some vendors have also developed ERP solutions tailored to the cannabis manufacturing and testing industries.
===ISO/IEC 17025 compliance support===
'''Cannabis testing LIMS requirement''': The system should support a laboratory's [[ISO/IEC 17025]] compliance efforts.


Below are representative examples of the most commonly used ERP software systems for cannabis testing laboratories, which may need to be integrated with other systems in the lab:
'''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.)


* '''[https://mjfreeway.com/software MJ Platform]''': Produced by the same company that develops Lead Data Systems, MJ Platform is described as a "cannabis business software solution" that handles both business management and seed-to-sale activities. The configurable, multilingual software provides an executive view of all operations, allowing for potentially improved decision making. Yields, analytics, and expense management are also able to be managed, among other things.
'''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.


* '''[https://guardiandatasystems.com/cannabis-software/cannabis-erp-executive-suite/ ROAR Executive Suite]''': Developed by Guardian Data Systems, the ROAR Executive Suite is marketed as a cloud-based cannabis ERP for improving profitability and reducing risk. The software reportedly has features such as GAAP-compliant accounting and government-specific reporting tools.


==Where do you find personnel for your laboratory?==
===NELAC, ORELAP, and ELAP compliance support===
According to ''Cannabis'' information resource ''Leafly'', 2018 saw the creation of more than 64,000 full-time jobs across the United States' state-legal ''Cannabis'' industry.<ref name="McLeodPart4_19">{{cite web |url=https://www.leafly.com/news/industry/are-you-qualified-to-work-in-a-cannabis-testing-lab |title=Part 4, Are You Qualified to Work in a Cannabis Lab? |author=McLeod, E. |work=Cannabis Jobs in America, 2019 |publisher=Leafly Holdings, Inc |date=08 March 2019 |accessdate=20 June 2019}}</ref> Among them were scientists and laboratorians responsible for testing ''Cannabis'' for safety and quality. But where did the various laboratories find their personnel, what qualifications were requested, and roughly how much did they end up getting paid?
'''Cannabis testing LIMS requirement''': The system should support a laboratory's NELAC or ORELAP compliance efforts.


===Finding personnel===
'''Cannabis testing LIMS requirement''': The system should support a laboratory's ELAP compliance efforts.
So you need qualified, motivated individuals to help propel your testing, extraction, etc. laboratory to success. You have multiple options at your fingertips.


1. Start specialized: Consider industry-specific hiring platforms. [https://vangst.com/ Vangst], for example, boasts partnering "with more than 600 companies to place 10,000 jobs across 14 states" as a cannabis industry recruiting platform.<ref name="HumistonPart2_19">{{{cite web |url=https://www.leafly.com/news/industry/how-to-get-hired-in-the-cannabis-industry |title=Part 2, How to Get Hired in the Cannabis Industry |author=Humiston, K. |work=Cannabis Jobs in America, 2019 |publisher=Leafly Holdings, Inc |date=06 March 2019 |accessdate=20 June 2019}}</ref> Another similar industry job search can be had with [https://cannainsiders.com/ Cannabis Insiders], a site for not only posting your jobs or resumes but that also aggregates job postings from other sites.
'''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.


2. Go more traditional: Specialty sites certainly have their appeal, but recruiters, businesses, and job seekers can also be seen taking to the more traditional job search sites. These sites often have their own search categories for ''Cannabis'' laboratory testing jobs for technicians and laboratory managers alike. Here are but a few examples:
'''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>:


* [https://www.glassdoor.com/Job/cannabis-laboratory-jobs-SRCH_KO0,19.htm Glassdoor.com]
* EL-V1M1-2016-Rev2.1 Module 1, "Proficiency Testing"
* [https://www.indeed.com/q-Cannabis-Testing-Laboratory-jobs.html Indeed.com]
* EL-V1M2-ISO-2016-Rev2.1 Module 2 "Quality Systems General Requirements"
* [https://www.linkedin.com/jobs/search?keywords=Cannabis_LAB&location= LinkedIn.com]
* EL-V1M4-2017-Rev2.2 Module 4, "Quality Systems for Chemical Testing"
* [https://www.monster.com/career-advice/article/marijuana-jobs Monster.com]
* EL-V1M5-2016-Rev2.0 Module 5, "Quality Systems for Microbiological Testing"
* [https://www.simplyhired.com/search?q=cannabis+laboratory+technician SimplyHired.com]
* [https://www.ziprecruiter.com/Jobs/Cannabis-Lab-Technician ZipRecruiter.com]


3. Find a recruiter: Don't necessarily want to go through all the hoops of finding the people for your lab? Turn to a recruiter/staffing agency to help you find who you're looking for. Businesses like [https://www.hempstaff.com/cannabis-recruiting-staffing HempStaff]], [http://thcstaffinggroup.com/ THC Staffing Group], and [https://www.viridianstaffing.com/ Viridian Staffing] specialize in finding personnel for the ''Cannabis'' and hemp industries.
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>


===Qualifications===
What qualifications should you be looking for in your personnel? This is a difficult question, exasperated by the increasingly unrealistic job requirements of hiring managers and other HR personnel.<ref name="HirschWhy19">{{cite web |url=https://www.shrm.org/resourcesandtools/hr-topics/talent-acquisition/pages/managing-hiring-managers-high-expectations-for-new-college-graduates.aspx |title=Why Hiring Managers' Expectations for New College Graduates May Be Unrealistic |author=Hirsch, A. |work=Talent Acquisition |publisher=Society for Human Resource Management |date=12 April 2019 |accessdate=20 June 2019}}</ref><ref name="MaurerEntry18">{{cite web |url=https://www.shrm.org/resourcesandtools/hr-topics/talent-acquisition/pages/entry-level-experience-requirements-hurting-hiring.aspx |title=Entry-Level-Experience Requirements Could Be Hurting Your Hiring |author=Maurer, R. |work=Talent Acquisition |publisher=Society for Human Resource Management |date=12 July 2018 |accessdate=20 June 2019}}</ref> You certainly want qualified people with high interest in the duties of your laboratory, particularly for the highly technical and professional aspects of the business. However, you also want to be realistic about any entry-level jobs you plan on offering, particularly in regards to years of experience required; you may be limiting your candidate field otherwise.<ref name="MaurerEntry18" /> Many of your analysts will likely have analytical chemistry, biology, or pharmaceutical degrees<ref name="McLeodPart4_19" />, though for the entry-level positions candidates may come from marijuana trimming backgrounds<ref name="CRMari17">{{cite web |url=https://www.cannarecruiter.com/marijuana-lab-testing-jobs/ |title=Marijuana Lab Testing Jobs: Ensuring Cannabusiness Quality |author=Canna Recruiter |work=Canna Recruiter Blog |date=24 August 2017 |accessdate=20 June 2019}}</ref>, ''Cannabis'' training schools<ref name="CTUWhat19">{{cite web |url=https://cannabistraininguniversity.com/what-is-involved-in-a-marijuana-lab-testing-job/ |title=What Is Involved In A Marijuana Lab Testing Job |author=Cannabis Training University |publisher=Zomage, LLC |date=2019 |accessdate=20 June 2019}}</ref>, or from a completely different background.<ref name="McLeodPart4_19" /> Most often, a bachelor's or associate's degree in a chemical or biological science and some kind of familiarity with laboratory work is required for a simple processing technician preparing samples. Analysts preferably have more verifiable experience in the laboratory than a technician and has some familiarity with chromatography practices and quality management. Lab directors or managers require some of the most rigorous requirements, with bachelor's being fine but perhaps a master's or PhD being a plus, and regulatory and hands-on experience with the various aspects of analytical laboratory testing.


===Compensation===
===Patient Focused Certification (PFC) compliance support===
Compensation for future personnel will likely vary depending upon the region and your business plan. {{As of|June 2019}}, ZipRecruiter shows a national average of $45,207 for a ''Cannabis'' lab technician<ref name="ZRCanna19">{{cite web |url=https://www.ziprecruiter.com/Jobs/Cannabis-Lab-Technician |title=Cannabis Lab Technician Jobs |publisher=ZipRecruiter.com |date=2019 |accessdate=20 June 2019}}</ref>, whereas a Maryland-based ''Cannabis'' testing lab ballparks it from $35,000 to $40,000.<ref name="McLeodPart4_19" /> The same company puts analysts between $40,000 and $60,000 and directors/managers at "at least six figures."<ref name="McLeodPart4_19" />
'''Cannabis testing LIMS requirement''': The system should support a laboratory's Americans for Safe Access (ASA) Patient Focused Certification (PFC) Program laboratory compliance efforts.


==What state regulations affect your lab decisions?==
'''Relevant LIMSpec''':
** https://www.cannaqa.wiki/index.php?title=RefWork:Known_cannabis_testing_regulations_in_the_United_States
* Unknown; unable to acquire document


==Closing==
'''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.


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

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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