Difference between revisions of "User:Shawndouglas/sandbox/sublevel1"

From CannaQAWiki
Jump to navigationJump to search
(Saving and adding more.)
 
(67 intermediate revisions by the same user not shown)
Line 1: Line 1:
'''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
{{ombox
{{ombox
| type      = content
| type      = content
| style    = width: 500px;
| style    = width: 500px;
| text      = This article should not be considered complete until this message box has been removed. This is a work in progress.
| text      = This article is a sandbox article. This is a work in progress and not a completed article for the encyclopedic wiki mainspace.
}}
}}


=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 a free generic plan builder 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 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
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?
* 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====
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.
This is where 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 go ahead and add here the vision as you understand it first. You can read it back and ask yourself if it still sounds like a genuinely good idea. And if it does, then once you have finished all of the other sections, you will in all probability still want to circle back and tweak this one, based on any epiphanies or aspects of the plan that perhaps you hadn't fully thought through initially. If you're looking for funds or other support, then this is the place to describe that effort, as many who you approach may only really read this section, at least initially, to determine whether it's worth reading further.
===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.


====General company description====
'''Relevant LIMSpec''':
What will your lab and overall business look like? This section lets you communicate what you see your lab/business as representing. 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., LLC, corporation, sole proprietorship, etc.
* 1.11 The system should support the creation of user-definable default sample registration input screens and/or preferences.


====Scope of business====
'''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.
[[File:Canna Lab Pic Facing Left.png|right|400 px]]This section describes the core of your lab. What testing will you provide, in what manner and for whom?


Cannabis analysis has pretty much distilled into some well-defined standard sets of tests and processes (see the chapter on [[LabLynx LIMS - Cannabis|The LabLynx Cannabis Solution]]), with appropriate instruments and methods. These range from potency testing (with accuracy tolerances mandated in some cases by the state) and terpenoid/balance analysis that validates product types, to pesticide, residuals and mold/fungus testing. In most cases, the entire range will probably need to be tested, since potency and safety are important aspects whether the product is medicinal or recreational. Increasingly, the most successful testing labs are the ones who can effectively guarantee those factors and deliver that certificate of analysis (COA) at the most competitive price and speediest turnaround, all while presenting a friendly and attractive, yet business-like and authoritative customer-facing image.


Customer-facing web portals are becoming the standard, and pickup and delivery of samples is another area that is attractive to customers, especially as most markets are no bigger than statewide, with many based at the municipal level. But as laws change, it would be well to keep an eye on scalability.
===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.


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 a cannabis lab primarily, there is risk reduction in offering your services in other areas as well. For example, many of the tests involved in cannabis testing (pesticides, mold/fungus, microbiology) are also common in food 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.
'''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.


Coupled with the idea of diversification is the choice of data management solution. There are, for instance, some cheap or even free cannabis LIMS available. But now 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 those regulations and standards - and demands of the industry itself - change as the cannabis industry continues to evolve and mature (see [[LabLynx LIMS - Cannabis|LIMS for Cannabis Testing]]).
'''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.


====Strategic considerations====
It's all well and good to decide that you want to deliver analytical lab services to the cannabis industry, but there's more to consider if you want to be truly successful. This section is where you identify and address important elements of your strategy to succeed. Ask yourself questions like:


* What will my competitive advantages be?
===Creation and management of additional protocols, labels, and analytical reports===
* What relationships or potential partnerships should I consider? Growers, dispensaries, collection/delivery services, extraction labs, subcontract labs...
'''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.
* 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, in his advice to those planning startups:
'''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.


<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="Zwilling">{{Cite web |author=Zwilling, M. |url=https://www.entrepreneur.com/article/229804 |title=10 Reasons Not to Write a Business Plan |publisher=Entrepreneur, Inc |date=06 November 2013}}</ref></blockquote>
'''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.


====Marketing plan====
===Flexible specification limit sets===
[[File:Marketing - girl-iphone-social-media facing right.jpg|left|400 px]]Your marketing plan includes two key elements: research and dissemination.
'''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.


You're already making a good start to your marketing plan research by reading this book. Marketing research falls into two categories: primary and secondary. While this and other resources like industry magazines, groups and communities (like you will find at [http://limsforum.com Limsforum.com]/[http://sciCloud.net sciCloud.net&reg;]) and blogs can provide great insight and information about the industry, you should also do your own ''primary'' research. 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?
'''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.


Next, devise your marketing strategies to get the word out about your products/services, and to keep them in the spotlight. That includes how much of your overall budget you need to apportion, and whether you are willing to accept that. But also, it includes strategic thinking so that your investment yields the most effective results in the most efficient manner. It also includes communicating your particular qualities that comprise your uniqueness and competitive edge.
'''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>


Today's marketing strategies are heavily internet-based, which can allow huge bang-for-buck results that were unimaginable in yesterday's traditional advertising models. But no matter how technology advances the options in this area, 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 very well, providing customer star ratings and feedback for all of their products. That is the modern-day "tech-ed up" version of word-of-mouth, and the traditional value of it still applies. 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.


====Operational plan====
===Third-party system integration===
Now it's nuts and bolts time. This is where the dream 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, with specifications and detailed descriptions. Some points to include:
'''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.  


* Testing techniques and costs
'''Relevant LIMSpec''':
** Instruments and equipment
* 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.
** Stocks, standards and reagents
* 27.6 The system should be able to interface directly with a third-party reporting tool.
** Submission process
* 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.
** Testing processes
** Reporting processes
* Quality control
* Customer service
* Location
* Legal requirements
** 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
** Trademarks, copyrights, or patents (pending, existing, or purchased; note: until federal laws change, cannabis-related brands cannot be trademarked)
* Staff
** Number of employees
** Type of labor: Skilled/unskilled/professional? Contracted? Full-time?
** Where and how will you find the right employees?
** Quality of existing staff
** Pay structure
** Training methods and requirements
** Employee roles
** Written job descriptions
** Written standard operating procedures (SOPs)
* Inventory
** Operating levels
** Stocks, standards and reagents suppliers
** Credit and delivery policies
** Managing storage conditions and expiration
** Software application (often available as part of LIMS functionality; see [[LabLynx LIMS - Cannabis|The LabLynx Cannabis Solution]])
* Administrative functions
** Outsourced? Onsite? Full-time/part-time? DIY?
* Financial management
** Credit policy (E.g., if you accept credit, what is the mechanism?)
** Accounts receivable: Net, aging tracking, collection policies
** Accounts payable: Recurring, one-time, aging, discounts
** Billing service or software?[[File:Canna Potency Test Prep.jpg|right|400 px]]
* Data Management: What software applications will you use? Will you need an IT infrastructure or go cloud? You'll want to make sure your LIMS is suited for the cannabis testing you'll do, e.g., [[LabLynx LIMS - Cannabis|The LabLynx Cannabis Solution]].
* Non-testing equipment: What hardware, workstation computers, telephone system, furniture and other fixtures will you use and how?


Another aspect of your operational plan is the design/layout of the premises. This is important, because you will presumably be contending with it for a long time. You'll want to keep some things in mind with your work space. 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 or workspaces. Keep commonly used large equipment away from heavy traffic areas but easily accessible.
'''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.


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="Hades">{{Cite web |author=Hades, Z. |url=http://bitesizebio.com/30527/starting-new-lab |title=Starting Up a New Lab: What you Need to Know |publisher=Science Squared/BitesizeBio |date=26 September 2016}}</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.


====Management and organizational structure====
===Instrument integration===
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 do some of all of it, with people already in those designated roles so that you pop in randomly just to ensure things are running as they should. Whatever your intended role and organizational setup, you'll need to specify it all here. If you will have more than about 10 staff, 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.
'''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.


[[File:Lab Organizational Chart.jpg|frame|left|Example organizational chart]]
'''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.


If you plan on having any advisers, consultants or board members, then add those plans to this section, including attorneys, accountants, insurance agent, banker and mentors.
'''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.


====Financial statements and projections====
What you and any partners, stockholders or investors bring to the table is presented here, shown in 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.


Creating a realistic financial plan with accurate data (where they are known) and sticking to its budget (or less) is crucial for your project to be successful. Even then, unforeseen economic or business factors may emerge and threaten its fulfillment.
===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).


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


* '''Important assumptions''': 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''': 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.


''Example of a Rates Prediction Table''


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


A Break-Even Analysis takes monthly income and expenses into account to calculate the monthly income needed to (a) break even and (b) become profitable.
'''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...


[[File:Break-Even Analysis.png|466 px]]<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.


* '''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''':
* 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.


[[File:Business Ratios Table.png|450 px]]<ref name="Fargo" />
'''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.




* '''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. And include an annual projection for a higher-level view showing the emergence from deficit operations to profitable business operations.
===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.


[[File:Business Plan - Monthly Profit Chart.png|450 px]]<ref name="Fargo" />
'''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.




[[File:Business Plan - Profit-Loss Yearly Chart.png|450 px]]<ref name="Fargo" />
===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.


Additionally, weekly projections will help you identify any 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.
'''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.


* '''Projected cash flow''': Having cash on hand, available for emergencies or just unforeseen contingencies is as important as meeting your profit/loss predictions. More than one business has been forced shut because they were operating too close to full cashflow and unanticipated expenses appeared. 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.


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


[[File:Business Plan - Cash Flow.png]]<ref name="Fargo" />
'''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.<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.


* '''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.


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


'''Startup expenses and required capital'''
'''Relevant LIMSpec''':
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.
* 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.)


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 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">{{Cite web |author=Fargo Medical Laboratories |url=http://www.bplans.com/laboratory_business_plan/executive_summary_fc.php |title=Laboratory Business Plan |publisher=bplans.com |access date=01 March 2017}}</ref>
'''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.


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 |author=Genovesi, L. |url=http://www.labmanager.com/business-management/2015/04/secrets-of-a-successful-start-up-lab |title=Secrets of a Successful Start-up Lab |publisher=Lab Manager |access date=01 May 2015}}</ref>


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


Some tips from others who have gone through the lab startup process:
'''Cannabis testing LIMS requirement''': The system should support a laboratory's ELAP compliance efforts.


* Safety glasses can vary wildly in price, from around $2 to around $11 or more.
'''Relevant LIMSpec''':
* Use less precise balances where tolerances aren't as critical, and save the more accurate one(s) for processes where it matters.
* 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.
* It's much better to buy tools and routine equipment (e.g., duct tape) at a hardware store than through science vendors.
* 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.
* Buy in bulk and buy early. Delays happen.
* 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.
* Some used equipment can be a great bargain. Pharma is hemorrhaging stuff that works. Maybe avoid the used LC/MS, but perfectly good rotary evaporators, vacuum ovens, centrifuges, fraction collectors, etc. 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.
* 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.
* Ultrasonic cleaners can be found for about a third of the usual price if you buy them from jewelers supply companies.
* 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.
* Ask for discounts. They are more available than you think, and can be 30 to 40%.
* 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.
* Check surplus outlets.
* 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.
* Look out for labs that are closing down.
* 16.6 The system shall allow for the documentation of and corrective and preventive action towards all types of nonconformance.
* eBay, restaurant supply companies (stainless steel ware, etc.) and other non-lab sources can save you money on the same items you may use in your lab.
* 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.
* labx.com, dovebid (www.go-dove.com - 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 (https://www.limsforum.com/marketplace/lab-supplies/)] 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.<ref name="ChemBark">{{Cite web |author= Paul Bracher |url=http://blog.chembark.com/2013/04/09/starting-up-a-chemistry-lab-advice-bargains |title=Starting Up a Chemistry Lab: Advice & Bargains |publisher=ChemBark (blog) |date=09 April 2013}}</ref><ref name="Reddit">{{Cite web |author=freesky99z |url=https://www.reddit.com/r/chemistry/comments/19aui0/tips_for_the_frugal_chemist/?st=izraqg9a&sh=5bee4861 |title=Tips for the frugal chemist? |publisher=Reddit chemistry |date=27 February 2013}}</ref>


'''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>:


==What are the financial considerations and available sources for financing?==
* EL-V1M1-2016-Rev2.1 Module 1, "Proficiency Testing"
** https://terpenesandtesting.com/cannabis-investors/
* EL-V1M2-ISO-2016-Rev2.1 Module 2 "Quality Systems General Requirements"
** https://www.begreenlegal.com/why-cannabis-testing-labs-in-california-are-attracting-investors/
* EL-V1M4-2017-Rev2.2 Module 4, "Quality Systems for Chemical Testing"
** https://mjnewsnetwork.com/business/casa-verde-capital-leads-investment-in-cannabis-testing-lab-cannalysis/
* EL-V1M5-2016-Rev2.0 Module 5, "Quality Systems for Microbiological Testing"
** 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?==
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>
** https://www.lablynxpress.com/index.php?title=Cannabis_Testing_Instruments,_Software,_and_Equipment
** https://www.limswiki.org/index.php/LII:Past,_Present,_and_Future_of_Cannabis_Laboratory_Testing_and_Regulation_in_the_United_States/Laboratory_testing_of_cannabis


==What data integrations are vital?==
** https://www.lablynxpress.com/index.php?title=External_Integrations_and_Your_LIMS


==Where do you find personnel for your laboratory?==
===Patient Focused Certification (PFC) compliance support===
** https://www.indeed.com/q-Cannabis-Testing-Laboratory-jobs.html
'''Cannabis testing LIMS requirement''': The system should support a laboratory's Americans for Safe Access (ASA) Patient Focused Certification (PFC) Program laboratory compliance efforts.
** https://www.glassdoor.com/Job/cannabis-laboratory-jobs-SRCH_KO0,19.htm
** https://www.simplyhired.com/search?q=cannabis+laboratory+technician
** https://www.ziprecruiter.com/Jobs/Cannabis-Lab-Technician
** https://cannainsiders.com/job-category/cannabis-laboratory-jobs/
** https://www.linkedin.com/jobs/search?keywords=Cannabis LAB&location=
** https://www.leafly.com/news/industry/are-you-qualified-to-work-in-a-cannabis-testing-lab
** https://cannabistraininguniversity.com/what-is-involved-in-a-marijuana-lab-testing-job/
** https://www.cannarecruiter.com/marijuana-lab-testing-jobs/
** https://www.monster.com/career-advice/article/marijuana-jobs


==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==
{{Reflist|colwidth=30em}}
{{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. 
Retrieved from "https://www.cannaqa.wiki/index.php?title=User:Shawndouglas/sandbox/sublevel1&oldid=16340"