Compliance should be top of mind for California’s cannabis operators. As the state works to implement regulations in the rapidly-growing cannabis industry, business owners need to be aware of what’s required to stay in good standing. As of January 1, 2019, that means reporting data to the state’s new track-and-trace system, Metrc.
What Is Track-and-Trace?
Track-and-Trace programs enable government oversight of commercial cannabis throughout its lifecycle—from “seed-to-sale.” Regulators can track a product’s journey from grower to processor to distributor to consumer, through data points captured at each step of the supply chain. Track-and-trace systems are practical for a number of reasons:
Taxation: ensure businesses pay their share of owed taxes
Quality assurance & safety: ensure cannabis products are safe to consume, coordinate product recalls
Account for cannabis grown vs. cannabis sold: curb inventory disappearing to the black market
Helps government get a macro view of the cannabis industry
The California Cannabis Track-and-Trace system (CCTT) gives state officials the ability to supervise and regulate the burgeoning cannabis industry in the golden state.
What Is Metrc?
Metrc is the platform California cannabis operators must use to record, track and maintain detailed information about their product for reporting. Metrc compiles this data and pushes it to the state.
Who Is Required To Use Metrc?
Starting January 1, 2019, all California state cannabis licensees are required to use Metrc. This includes licenses for cannabis: Proper tagging ensures that regulators can quickly trace inventory back to a particular plant or place of origin.
How Does Metrc Work?
Metrc uses a system of tagging and unique ID numbers to categorize and track cannabis from seed to sale. Tagged inventory in Metrc is sorted into 2 categories: plants and packages. Plants are further categorized as either immature or flowering. All plants are required to enter Metrc through immature plant lots of up to 100/plants per lot. Each lot is assigned a lot unique ID (UID), and each plant in the lot gets a unique Identifier plant tag. Immature plants are labeled with the lot UID, while flowering plants get a plant tag. Metrc generates these ID numbers and they cannot be reused. In addition to the UID, tags include a facility name, facility license number, application identifier (medical or recreational), and order dates for the tag. Proper tagging ensures that regulators can quickly trace inventory back to a particular plant or place of origin.
Packages are formed from immature plants, harvest batches, or other packages. Package tags are important for tracking inventory through processing, as the product changes form and changes hands. Each package receives a UID package tag, and as packages are refined and/or combined, they receive a new ID number, which holds all the other ID numbers in it and tells that package’s unique story.
Do I Have To Enter Data Into Metrc Manually?
You certainly can enter data into Metrc manually, but you probably won’t want to, and thankfully, you don’t have to. Metrc’s API allows for seamless communication between the system and many of your company’s existing tracking and reporting tools used for inventory, production, POS, invoices, orders, etc. These integrations automate the data entry process in many areas.As California operators work to get their ducks in a row, some ambiguity and confusion around Metrc’s roll out remains.
Adopting and implementing cannabis ERP software is another way operators can automate compliance. These platforms combine software for point of sale, cultivation, distribution, processing and ecommerce into one unified system, which tracks everything and pushes it automatically to Metrc via the API. Since they’ve been developed specifically for the cannabis industry, they’re designed with cannabis supply chain and regulatory demands in mind.
As California operators work to get their ducks in a row, some ambiguity and confusion around Metrc’s roll out remains. Only businesses with full annual licenses are required to comply, leaving some temporary licensees unsure of how to proceed. Others are simply reluctant to transition from an off-the-grid, off-the-cuff model to digitally tracking and reporting everything down to the gram. But the stakes of non-compliance are high— the prospect of fines or loss of business is causing fear and concern for many. Integrated cannabis ERP software can simplify operations and offer continual, automated compliance, which should give operators peace of mind.
No matter the size of your cannabis greenhouse operation, keeping your plants alive and healthy requires the best possible growing environment. This means greenhouse managers and personnel must frequently monitor the status of environmental conditions and equipment. The sooner someone discovers extreme temperature fluctuations, rising humidity or equipment failure, the more inventory you can save.
That’s why integrating a remote monitoring system into your greenhouse operation can save you time, money and anxiety. Monitoring systems that use cloud-based technology let you see real-time status of all monitored conditions and receive alerts right on your mobile device.
Installing a monitoring system and sensors can be easier than you might think. Here are answers to ten questions to ask before installing a cloud-based monitoring system:
What is required to use a remote monitoring system?
Most remote monitoring systems require an internet or WiFi connection and access to an electrical outlet. Programming is done through a website, so it’s easiest to use a computer for the initial setup. If you don’t have an internet connection at your location, you’ll want to choose a cellular system. Make sure that there’s sufficient signal strength at your site, and check the signal quality in the area before purchasing a cellular device.
2. How do we determine what kind of monitoring system and sensors we need?
A reputable manufacturer will have a well-trained support team that can assess your needs even without a site visit to determine which products are best for your application. If you feel you need them to check out your greenhouse operation,many companies can set up a video conference or FaceTime chat to substitute for being on site.
You will want to provide details about the scope and purpose of your cannabis growing operation. Important factors to discuss include:
Skeletal structure of the greenhouse (metal, plastic, wood, etc.) and the covering material (glass or plastic).
Floor space square footage and height of each of your greenhouses.
Number of greenhouse structures in your operation.
Outdoor climate to determine if you rely more on heating or air conditioning and the level of humidity control needed.
Space dedicated to phases of growth (cloning and propagation, vegetative, flowering) and the microclimates needed for each.
Types of lighting, ventilation and irrigation systems.
Level of technological automation versus manual operation in place.
The monitoring system representative will then determine the type of system that would best serve your operation, the number of base units you will need and the types of sensors required.
The representative should also be able to provide tips on the placement of the sensors you’re purchasing. For example, to ensure thorough air temperature coverage, place sensors throughout the greenhouse, next to the thermostat controlling the room temperature and in the center of the greenhouse out of direct sunlight.
Note that there shouldn’t be a cost for a demo, consultation or assistance throughout the sales process. Be sure to ask if there are any fees or licenses to keep using the monitoring equipment after you purchase it.
3. Are sensors included with the monitoring system?
In most cases, sensors are sold separately. The sensors you select depend upon the conditions you want to monitor and how many you can connect to your base unit. Certainly, temperature is critical, but there are many other factors to deal with as well, such as humidity, CO2, soil moisture, water pH, power and equipment failure, ventilation and physical security.
For example, humidity has a direct impact on the photosynthesis and transpiration of plants. High humidity can also cause disease and promote the growth of harmful mold, algae and mildew. Sensors can detect changes in humidity levels.
Like any other plant, cannabis needs CO2 to thrive, so it’s a good idea to include a CO2 sensor that will signal to the monitoring device when readings go out of the preset range. There are even sensors that you can place in the soil to measure moisture content to help prevent over- or underwatering, budget water usage costs, promote growth and increase crop yield and quality.
Of course, all the critical systems in your growing facility—from water pumps to irrigation lines to louvers—rely on electrical power. A power outage monitoring sensor detects power failure. It can also monitor equipment for conditions that predict if a problem is looming, such as power fluctuations that occur at specific times.
Ventilation systems not only help control temperature, they also provide fresh air that is critical to plant health. Automated systems include features like vented roofs, side vents and forced fans. Sensors placed on all these systems will send personnel an alert if they stop running or operate outside of preset parameters.
To monitor the physical security of your greenhouses, you can add sensors to entrance doors, windows, supply rooms and equipment sheds. During off hours, when no staff is on duty, you can remain vigilant and be alerted to any unauthorized entry into your facility.
4. Do monitoring systems only work with the manufacturer’s sensors?
Not necessarily. For example, certain monitoring units can connect with most 4-20mA sensors and transmitters regardless of the brand. When selecting sensors, you might have a choice between ones that are designed by the manufacturer to work specifically with the monitoring system or universal components made by a third party. If the components aren’t made by the system manufacturer, you’ll want to find out if they have been tested with the monitor you are choosing and if you need to work with another vendor to purchase the parts.
5. Is a monitoring system easy to set up, or do we need to hire an electrician?
Many monitoring systems are quick and easy to install, and users can often set them up without hiring an outside expert. Look for one that requires only a few simple physical installation steps. For example:
Mount the device to the wall or somewhere secure;
Plug it into an electrical outlet and an internet connection;
Connect the sensors.
You connect the sensors to the base unit’s terminal strip using wire, which is included with many sensors. The range of many wired sensors can be extended up to 2,000 feet away from the base unit by adding wire that can be easily purchased at any home store. It’s a good idea to hire an electrician if you need to run wires through walls or ceilings.
Usually, once you plug in the device and connect the sensors, you then create an account on the manufacturer’s designated website and begin using your device. There should be no fee to create an account and use the site.
If the manufacturer doesn’t offer installation services, ask if they can recommend a local representative in your area who can set up your system. If not, make sure they provide free technical support via phone or email to walk you through the installation and answer any questions you might have about programming and daily usage.
6. Is there a monthly fee to access all the functionality of a monitoring device?
Many web- or cloud-based systems provide free functionality with some limitations. You might have to purchase a premium subscription to unlock features such as text messaging, phone call alerts and unlimited data logging access.
7. Should we get a system that is wired or wireless? Will we need to have a phone line, cable, internet or something else?
Wireless can mean two different things as it relates to monitoring: how the system communicates its data to the outside world and how the sensors communicate with the system.
The most popular systems require an internet or WiFi connection, but if that’s not an option, cellular- and phone-based systems are available.
A hardwired monitoring system connects the sensors to the base device with wires. A wireless system uses built-in radio transmitters to communicate with the base unit. Some monitoring systems can accommodate a combination of hardwired and wireless sensors.
8. Can one system monitor several sensor inputs around the clock?
Once the monitoring system is installed and programmed, it will constantly read the information from the sensors 24/7. Cloud-based systems have data logging capabilities and store limitless amounts of information that you can view from any internet-connected device via a website or app.
If the system detects any sensor readings outside of the preset range, it will send an alarm to all designated personnel. The number of sensors a base unit can monitor varies. Make sure to evaluate your needs and to select one that can accommodate your present situation and future growth.
When a monitoring system identifies a change in status, it immediately sends alerts to people on your contact list. If you don’t want all your personnel to receive notifications at the same time, some devices can be programmed to send alerts in a tiered fashion or on a schedule. Multiple communications methods like phone, email and text provide extra assurance that you’ll get the alert. It’s a good idea to check the number of people the system can reach and if the system automatically cycles through the contact list until someone responds. Some systems allow for flexible scheduling, so that off-duty personnel don’t receive alerts.
9. Do monitoring systems have a back-up power system that will ensure the alarming function still works if the power goes out or if someone disconnects the power?
The safest choice is a cloud-based system that comes with a built-in battery backup that will last for hours in the event of a power failure. Cloud-based units constantly communicate a signal to the cloud to validate its online status. If the communication link is interrupted—for example by a power outage or an employee accidently switching off the unit—the system generates an alarm indicating that the internet connection is lost or that there is a cellular communications problem. Users are alerted about the disruption through phone, text or email. All data collected during this time will be stored in the device and will be uploaded to the cloud when the internet connection is restored.
If you opt for a cloud-based monitoring system, make sure the infrastructure used to create the cloud platform is monitored 24/7 by the manufacturer’s team. Ask if they have multiple backups across the country to ensure the system is never down.
10. What should we expect if we need technical support or repairs to the system?
Purchase your system from a reputable manufacturer that provides a warranty and offers full repair services in the event the product stops working as it should. Also, research to make sure their tech support team is knowledgeable and willing to walk you through any questions you have about your monitoring system. Often, support specialists can diagnose and correct unit setup and programming issues over the phone.
It helps to record your observations regarding the problem, so the tech team can look for trends and circumstances concerning the issue and better diagnose the problem. Ideally, the manufacturer can provide loaner units if your problem requires mailing the device to their facility for repair.
LabVantage Solutions, known in other testing industries as a leader in laboratory information management systems (LIMS), has launched their own cannabis-specific LIMS. Unveiled at the Cannabis Science Conference in Portland, OR, the purpose-built software is designed specifically for cannabis testing and certification.
Here are a few key highlights of their system, taken from the press release:
Available through perpetual licensing or SaaS
One platform for all tests, instruments, sample information, and results data, with option to embed ELN, LES, and other modules
Registers sample requests, including a portal for remote requests from growers and distributors
Fully audited sample lifecycle and audit trail
Certificates of Analysis customized for local regulatory requirements
Includes American Herbal Pharmacopoeia® tests for Cannabis Inforescense.
LabVantage says their system can support ISO/IEC 17025 compliance, ISO 9001:2015, 21 CFR Part 11 and Annex 11 and GLPs as well. According to Bob Voelkner, vice president of sales and marketing, it has a very open architecture as well as web services technology, which allows for integration with METRC and other traceability software platforms. “We know the testing methodologies these labs use, so the customer doesn’t have to create that from scratch,” says Voelkner. “This is meant to be out of the box and ready-to-use, so the customer can get up and running with minimal lag time.” LabVantage has actually been a provider of LIMS solutions for over 30 years and they serve a broad range of lab types.
Voelkner says they’ve been working with clients at cannabis labs over the past few years to configure their LIMS for this space specifically. “The lab managers can modify workflows on their own without having to write code,” says Voelkner. “We have a well-established solution with a good track record, that’s been around for a while and is proven. Some other players that are brand new to the space may be new to LIMS and that may not be a good thing. We are a market leader in the global LIMS space with a proven product that is very well established and very powerful.” Voelkner adds that lab managers get to own their data, not LabVantage. “You own the data. It is your database and it is proprietary to you. It is yours to use as you see fit.”
Lab managers have the option to configure the system to adapt to new compliance issues themselves, or work with the LabVantage professional services team to build it out further. “This particular space is new and emerging, it is pretty dynamic — we see a lot of change happening,” says Voelkner. “We believe this space needs a highly flexible platform and this is a proven technology solution with a lot of configurability built into it.”
Have you paused to consider that quality assurance is a moving target rather than a destination? It is culture within a company that requires constant improvement and change, rather than the work of a select few to reach one defined end goal. Quality, therefore, is not a box that must simply be checked but an overarching and driving force propelling organizations forward.
For those within the cannabis industry and specifically cannabis testing labs, quality assurance is critical to having a successful and thriving business within the rapidly evolving industry. Dr. Kim Ross, who earned her Ph.D. at the University of Colorado in Molecular Biology, and also has worked with multiple cannabis labs, says, “It is not that often that you get a new testing industry born these days and people are scrambling to borrow processes from other industries and apply these to the cannabis industry.” Those within cannabis testing labs are looking towards established industries like water and food testing labs to serve as a quality assurance beacon. Ross elaborates:
The cannabis industry is operating in the absence of federal oversight. If you think about it, the water, food, and pharmaceutical industries have federal oversight. In lieu of that, it is up to states to adopt regulatory practices and enforcement strategies to uphold a level of compliance and data defensibility that these types of regulators have seen in their careers working in the FDA, EPS, NELAC or ISO.
For cannabis testing labs, the stakes are high. First, there is the need to keep up with the rapidly evolving industry climate as more and more states and governing bodies are setting requirements and expectations for quality and compliance. It is in nobody’s best interest to fall behind or be a late adopter to the increasingly regulatory compliance environment.
Additionally, untrustworthy data sets can have detrimental impacts on people and patients. Medical applications of cannabis require specific results in order to ensure the safety of patients, many of which are immunocompromised. Beyond damage to people and patients, businesses themselves can be hurt if a cannabis testing lab were to present inaccurate or flawed data sets. Ross shared hypothetical examples of potential negative impacts:
If, for example, you fail a product for microbiology based on false-positive results then it incurs damages to the client because now their product can’t go to market. Additionally, falsely inflated THC results are also a huge problem in the industry, and can result in downstream problems with edible dosing or consumer satisfaction.
A quality assurance system can minimize risk and maximize adherences to proper procedure, resulting in reliable data. Recalls, product issues and lawsuits cost organizations tremendous amounts of time and money, both to manage the problem at hand and prevent future incidents. Not to mention, the immeasurable damage done to the brand & industry by being viewed as untrustworthy–especially as a consumable product. “Ensuring data defensibility and data integrity protects the laboratory from lawsuits,” says Ross. “That is a really important piece of a quality assurance system for a laboratory.”
One common misconception is viewing quality assurance as a cost center rather than a profitability maximizer. A robust quality assurance system is a competitive advantage–especially for those who are not yet mandated to be compliant to a particular standard, like ISO/IEC 17025, but choose to pursue that accreditation knowing it reflects reliability. In many ways, quality assurance can be summarized as “say what you do, and do what you say”, with a willingness to allow third-party confirmation of your commitment and practice. “Accreditation gives an unbiased stamp of approval that helps ensure data defensibility in the laboratory,” affirms Ross.
Accreditation as a result of quality assurance ultimately leads to reliable and trustworthy data sets. Ross shared:
It might appear to be easy to buy expensive instrumentation, accept samples, and produce data. There are so many ways to do that, some of which are incorrect, and therefore accreditation is really an opportunity to have professionals evaluate methodology and post-analytical data processing to ensure that it is scientifically sound. It is an opportunity for a laboratory to be confident that their processes and reporting procedures are robust and error free.
Remember: this is a new industry. There aren’t firmly established methods and procedures like other legacy industries. “We are operating in a time and space where there is no standard methodology and that makes oversight by a third party even more important,” shares Ross. When a company opts to pursue accreditation they are indicating a willingness to be honest and transparent with their business processes, procedures, outcomes and data. Accreditation, therefore, is necessary for this emerging industry. Having a robust, inclusive quality assurance system in place will ease and quicken their pursuit of accreditation.The stress on an audit day when there is a digitized system is vastly lower than a system that is printed and physically maintained.
Not all quality assurance systems are created equal. There are still some companies seeking to implement systems that lack the modernization necessary to truly propel them forward towards continuous improvement and scalability. Quality assurance software with widespread use and adaptation across organizations is both scalable and in support of continuous improvements. Binders, rows of filing cabinets and complicated excel spreadsheets are not a scalable backbone for a quality system.
Beyond the accessibility and traceability that a digital system creates, it also protects. “We can protect that data with credentialed logins for key personnel and have information at our fingertips to reduce the regulatory stress on all personnel,” says Ross. The stress on an audit day when there is a digitized system is vastly lower than a system that is printed and physically maintained.
For those in the cannabis industry, specifically cannabis testing labs, there is an unequivocal advantage to implementing a system that supports continuous improvement, reliable data sets and the very best in business practices. Doing so will help sustain and grow the industry, and could be pivotal in transforming the production, market and research of cannabis.
The stage is set: cannabis legalization is rolling out around the world. With legalization comes regulations and smart companies will adapt to make new requirements work for them. In the end, our shared goal (as industry, consumers and government) is the same: provide safe, high-quality, reliable products. This is where traceability comes in.
If a cannabis product isn’t safe (cannabis is vulnerable to the same kinds of hazards as most food products), the reputation of the entire industry suffers. Earning public trust is the first step toward favorable government regulations. With upcoming decisions that will decide taxation and distribution, it’s more important than ever that cannabis producers can react quickly if recalls should occur – and that means taking traceability seriously.
Comprehensive Traceability for Cannabis Means More Than Legality
A crucial key to producing safe and high-quality cannabis products is detailed traceability. Many states require cannabis businesses to use systems like Metrc, a technology that uses RFID tags to track cannabis from seed to sale to ensure nothing is diverted to the black market. However, Metrc focuses only on the chain of custody, not on the safety or quality of the product.
Ensuring a secure supply chain is only one piece of the cannabis puzzle. Public health hazards like toxic chemical contamination, mold growth and pathogenic contamination introduced by pests or improper employee handling need to be controlled in order to earn public trust and comply with regulations. State-mandated traceability systems don’t address these imperatives, so an effective safety technology that includes traceability, in addition to mandated systems like Metrc, is absolutely necessary to complete the cannabis picture.
Automation Technology Supports Cannabis Companies’ Growth and Helps With Audits
Cannabis professionals are aware of the regulatory scrutiny the industry is under and many have turned to automation technology to help stand up to this scrutiny, as well as collect and manage all the data necessary for compliance. Automating data collection pays off in several ways. For one, interconnected, real-time IoT technologies that are accessible to the entire facility 24/7 are giving cannabis businesses the tools they need to create the best possible products now, as well as providing them with the data they need to make their products even better. Since frequent audits are a part of the legalization transition, automation also makes preparing for audits and inspections a matter of minutes instead of days.
Ron Sigman, chief executive officer of marijuana compliance consulting firm Adherence Corp. and former investigator for the Marijuana Enforcement Division (MED) in Colorado, lists the most common violations for cannabis businesses that he found during more than 200 audits in an interview for Marijuana Business Daily. These violations include:
Metrc issues, especially accounting not matching inventory (too many plants or ounces of marijuana on the premises);
Security issues like lack of sufficient camera coverage;
Failure to upgrade licenses;
Improper or incomplete training of new employees.
Adopting safety and traceability concepts that the food industry developed over many decades can yield huge benefits for cannabis businessesA proper cannabis traceability technology mitigates these problems by providing notifications of inventory inconsistencies, certification expirations and more. Traceability for cannabis must be able to handle the complexities of procedures like terpene extraction and injection. With the rapid growth of the industry, it must be able to set targets and track actuals. It should track, not just cannabis plants and related derivatives, but also every other ingredient, material and packaging material used during production. There must be monitoring at each stage of production and a system in place to ensure all employee training is up to date. Preventative maintenance must be scheduled and tracked and hazards must be identified and controlled. In the event of an audit or recall, precise mass-balance calculations must be available to account for every gram of product, including non-cannabis ingredients like coconut oil and packaging materials like pouches and labels.
Detailed traceability can make the difference between a cannabis business keeping their license or being shut down. “You have to make a diligent effort to stay compliant 365 days out of the year, because you never know when a regulatory agency is going to come knocking on your door,” says Sigman. Knowing exactly what went wrong when and where allows a company to make changes so failures don’t happen again.
Higher Standards Will Be Demanded
The standard sought by most in the cannabis industry is only GMP (Good Manufacturing Practice) certification, which is actually the lowest level of certification possible in food production. With the public demand for edibles and concentrates on the rise and major retailers scrambling for seats at the table, the demand for transparency from growers and manufacturers will increase. Cannabis companies will soon find that GMP compliance simply won’t be enough to earn trust and expand their market share, especially when it comes to edibles and concentrates.
“Every day, patients express interest and assurance of wanting to know that the foods and medicines they consume are safe and of the best quality available,” says Lindsay Jones, president of Curaleaf Florida, the first medical cannabis company in Florida to achieve SQF Certification. Safe Quality Food (SQF) certification ensures a company meets the highest levels of safety and quality on a reliable basis. Curaleaf has set a new bar in the industry that others will be compelled to follow and they should be congratulated for their proactive vision.
Adopting safety and traceability concepts that the food industry developed over many decades can yield huge benefits for cannabis businesses, but it will be interesting to watch the technology evolve to accommodate the specific needs of retailers and consumers. Imagine a traceability system that ensures safety and quality while also tracking consistency and potency.
The Future of Cannabis Is Bright
The emerging cannabis industry is facing challenging hurdles on its path to widespread legalization and acceptance but the forecast is sunny – for companies who are prepared.
Government regulations keep millions of Americans safe every year by controlling what companies can put in their products and the standards those products must meet to be sold to consumers.
Enter the strange case of legal cannabis: In order for cannabis to be legally distributed by licensed medical professionals and businesses, it must be tested. But unlike other consumable goods, cannabis is not regulated by the FDA. Without an overarching federal policy requiring cannabis testing laboratory accreditation, the testing and laboratory requirements differ greatly across state lines.For medical cannabis specifically, accredited testing facilities are especially important.
To be federally regulated, cannabis would first have to be federally legalized. It turns out that states and businesses alike are not willing to wait for a federal mandate. Many states have begun to adopt standards for cannabis testing and some, such as Ohio, have even announced mandatory ISO/IEC 17025 accreditation for all cannabis testing laboratories. As the industry evolves, increased compliance expectations are certain to evolve in tandem.
Some cannabis labs have even taken the initiative to seek ISO/IEC 17025 accreditation of their own volition. Seth Wong, President of TEQ Analytics Laboratories, shared in a press release:
“By achieving ISO/IEC 17025 accreditation, TEQ Analytical Labs believes that we can address the concerns throughout the cannabis industry regarding insufficient and unreliable scientific analysis by providing our clients with State required tests that are accredited by an international standard.”
There are key reasons why accreditation in cannabis testing labs is important. First and foremost, cannabis is a consumable product. Like fruits and vegetables, cannabis is prone to pesticides, fungi and contaminants. The result of putting a potentially hazardous material on the market without proper and documented testing could lead to a public health crisis. An accredited testing lab, however, will ensure that the cannabis products they test are free from harmful contaminants.
For medical cannabis specifically, accredited testing facilities are especially important. Because many consumers of medical cannabis are immuno-compromised (such as in the case of chemotherapy patients), ensuring that products are free from any and all contaminants is critical. Further, in order to accurately determine both short- and long-term effects of prescribed cannabis consumption, accredited and compliant laboratories are necessary.
Accreditation standards like ISO/IEC 17025 also provide confidence that testing is performed properly and to an internationally accepted standard. Rather than returning a “pass/fail” rating on products, the Cannabis Safety Institute reports that an ISO/IEC 17025 laboratory is required to produce numerical accuracy percentages in testing for “at a minimum, cannabinoids, pesticides, microbiology, residual solvents, and water activity.” Reliable data sets that can be reviewed by both accreditors and the public foster trust between producers and consumers.
Finally, ISO/IEC 17025 accreditation demonstrates that a laboratory is properly staffed and trained. The Cannabis Safety Institute’s “Standards for Cannabis Testing Laboratories” explains that conducting proper analytical chemistry on cannabinoids (the chemical compounds extracted from cannabis that alter the brain’s neurotransmitter release) requires personnel who have met specific academic and training credentials. A system to monitor, manage and demonstrate proficiency is necessary to achieve and maintain accreditation. With electronic systems in place, this management and documentation minimizes risk and also minimizes administrative time tracking and maintaining training records.
Following the proper steps of a standardized process is key to improving and growing the cannabis industry in coming yearsFor cannabis testing labs, utilizing a comprehensive software solution to achieve and maintain compliance to standards such as ISO/IEC 17025 is key. Absent of a software solution, the necessary compliance requirements can become a significant burden to the organization. Paper tracking systems and complex spreadsheets open up organizations to the likelihood of errors and ultimately risk.
Because ISO/IEC 17025 has clearly defined expectations for training, a software solution also streamlines the training process while simultaneously documenting proficiency. By utilizing role-based trainings, organizations can be confident employees are receiving proper onboarding and in-service training. Additionally, the effectiveness of training can be proven with reports, which results in smoother audits and assessments.
Following the proper steps of a standardized process is key to improving and growing the cannabis industry in coming years- which means utilizing technology tools such as electronic workflows to ensure proper process controls. Beyond adding critical visibility, workflows also create efficiencies that can eliminate the need to increase staffing as companies expand and grow.
For an industry that is changing at a rapid pace, ensuring traceability, efficient processes and visibility across organizations is paramount. Using a system that enables automation, process control, document management and documented training procedures is a step in the right direction. With the proper software tools in place, cannabis testing labs can achieve compliance goals, demonstrate reliable and relevant results and most importantly ensure consumer safety.
BioMauris, LLC became the 5th company in the United States to win a state contract for a seed-to-sale platform today. BioMauris is a technology company that manages product tracking, fulfillment and distribution with a focus on the healthcare market. According to a press release, the company announced today that the state of Iowa selected BioMauris to manage their tracking system for the medical cannabidiol (CBD) program.
That program’s contract includes inventory tracking, medical cannabidiol sales and patient and caregiver registration. In 2014, Iowa’s Medical Cannabidiol Act was signed into law. Three years later, in May of 2017, Governor Terry Branstad expanded the state’s program, including manufacture and dispensing in the previous legislation. On December 1st, 2018, Iowa expects sales to begin and fully implement the program.
This is BioMauris’ first state contract in the cannabis industry. According to the press release, BioMauris bases their platform on Salesforce for point of sale, tracking, customer loyalty and distribution services in the healthcare sector. The company says they use Salesforce because it is extremely customizable and secure.
According to Erik Emerson, founder and president of BioMauris, they’re poised to deliver on this front, given their experience in other industries. “Our team has extensive history in the pharmaceutical business, and therefore has a unique appreciation for data integrity and security,” says Emerson. “Additionally, we fundamentally believe the opportunity to track patient progress and associate the benefits received with the products used, is an incredible opportunity for the cannabis industry.” BioMauris has worked with clients on similar projects in the healthcare space for some time.
The company touts their platform as fully PCI-DSS and HIPAA compliant, allowing them to process payments and protect sensitive patient information. “Our patented technology, makes this not only possible, but simple for all users,” says Emerson. “We are excited to bring our product to the great state of Iowa and look forward to a long partnership with them. We believe strongly in what Iowa is attempting to do with their program and believe it is a perfect fit with our strategy for the cannabis industry.”
On February 8th, Peter Antolin, the deputy director for the Washington State Liquor and Cannabis Board (WSLCB), sent an email to licensees explaining why the transition to their new traceability system was disrupted. Last Saturday, someone gained access to the sensitive information in Leaf Data Systems, the state’s traceability software that is powered by MJ Freeway.
“A computer vulnerability was exploited on Saturday, allowing unauthorized access to the traceability system,” Antolin told licensees in the email. “There are indications an intruder downloaded a copy of the traceability database and took action that caused issues with inventory transfers for some users. We believe this was the root cause of the transfer/manifest issue experienced between Saturday and Monday.”
The email goes on to say that no personally identifiable information was available to the ‘intruder,’ but some sensitive information was clearly accessed. That data includes route information of manifests filed between February 1st and 4th as well as transporter vehicle information including VIN, license plate number and vehicle type, according to the email.
That email leaves much to be desired. For one, they do not exactly have a solution, instead trying to alleviate licensees’ worries with a hollow inanity full of meaningless jargon: “The WSLCB and MJ Freeway continue to implement several strategies to prevent future vulnerabilities to future intrusions,” reads the email. “This includes full logging and monitoring and working with third-party entities. Since this remains an active investigation, details on security are not publicly available.” However, today the WSLCB is hosting a webinar where Peter Antolin, their IT division, the MJ Examiners unit and enforcement will be available to answer questions, according to the email.
This is by no means the first security breach that Washington and MJ Freeway have suffered. In May of 2017, Washington originally selected Franwell’s METRC as the contract partner for their traceability software system. Less than a month later in June of 2017, after a mistake in the selection process, Washington selected MJ Freeway instead of Franwell for the traceability contract. Three days later, MJ Freeway’s source code was stolen and published online. Then in September, Nevada cancelled their contract with MJ Freeway after a security breach, their services crashed in Pennsylvania and Spain, and in October it became clear that the company could not meet the October 31 deadline for their new Washington contract.
In November of 2017, BioTrackTHC, the company that held the previous contract for Washington’s traceability software, helped the state through the transition period with a temporary Band-Aid solution to hold the state over until January of 2018. A month after they expected to implement the new MJ Freeway system, the latest security breach occurred this week and disrupting the rollout yet again.
At the end of the email Antolin sent to licensees yesterday, he says there will continue to be attempts to breach the system’s security. “The bottom line is that this incident is unfortunate,” says Antolin. “There will continue to be malicious cyberattacks on the system. This is true of any public or private system and is especially true of the traceability system.” This begs a few questions: why aren’t we hearing about this kind of security breach in other states’ traceability systems? What are other companies doing that prevents this from happening? Why does this keep happening to MJ Freeway?
California’s full legal cannabis market officially opened its doors for business on January 1st, 2018. Following a relatively short time frame when they announced the first licenses awarded less than a month ago, retail stores were open for business in counties throughout California. Customers came out in full force, with long lines on the opening day, with some hundreds deep stretching around blocks.
For the quick turn around time between implementing regulations and awarding temporary licenses, the grand opening of the cannabis market in the nation’s most populous state proceeded smoothly. Only a handful of minor hiccups associated with the launch were reported throughout the state. In the grand scheme of things, that’s a pretty good job for a new regulatory agency (The Bureau) tasked with regulating such a massive fledgling market.
One major and definitely foreseeable hiccup in the launch of California’s new medical and adult use markets was the failure to implement tracking software. According to Michael Blood with The Associated Press, licensed businesses are being asked by the California Department of Food and Agriculture to manually document sales and transfers of cannabis with paper invoices.
While the Department said the traceability system was implemented Tuesday, Blood says, cannabis businesses are not required to use it and will be trained on how to operate it before it becomes required to use later in 2018.
Local control regulations in California means that businesses must first seek approval from local authorities before attaining a temporary license from the state to operate. That coupled with the rolling process of awarding licenses meant that only some cannabis businesses could officially open their doors. Municipalities throughout California handle regulating cannabis differently.
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