AirMed and FDA CFR 21
We are sometimes asked if AirMed meets FDA standards. First, please be aware that the FDA is a department of the US government. The specific portion of FDA regulations relevant to software such as AirMed is part CFR 21. As it is an American standard, Health Canada does not require CFR Part 21 compliance as part of the Cannabis Act Regulations. And while AirMed was designed for the Canadian cannabis industry and to comply with Health Canada regulations, AirMed does conform to CFR Part 21 with respect to electronic record keeping, audit trails, and electronic signatures.
Many agencies throughout the world are responsible for issuing and enforcing regulations that affect businesses. The regulations affecting software such as AirMed are typically those related to records management compliance. And while there are many regulatory agencies involved in records management, for the most part the regulations themselves are similar from country to country and agency to agency. The purpose of them, in general, is to ensure the security, confidentiality and authentication of electronic records.
The U.S. FDA regulates food, drugs, medical devices, biologics, animal feed and drugs, cosmetics and radiation-emitting products such as cell phones for the U.S.A. The FDA’s rules for manufacturing and distribution are designed to protect consumers and promote public health. In the U.S. Code of Federal Regulations (CFR), Title 21 deals with Food & Drugs. Until recently, the regulations in this title required paper records with handwritten signatures.
Back in 1997, part 11 of 21 CFR was enacted to cover the use of electronic records and electronic signatures. Commonly known as 21 CFR 11, this part defines the criteria “under which the agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.”
Essentially, the concerns about using electronic records are that records may be lost in a system crash, the data may become corrupt or modifications may be made without proper authorization. In addition, since printed documents with hand-written signatures are recognized as legally binding on the signators, the agencies are looking for ways to make electronic records similarly binding on their owners. The regulations have been proposed to ensure that whenever an organization replaces printed documents with electronic data, there are checks and balances in place to ensure integrity of the electronic records so that they can be legally equivalent to printed records.
AirMed has a range of features that satisfy standards for security, authentication, validation and auditing as outlined in 21 CFR 11 and other regulations.
For more detailed information visit: Code of Federal Regulations (CFR) | FDA
For more information on how AirMed helps you meet compliance, visit our Compliance page or our Frequently Asked Questions page. If you’d like to discuss your specific needs, please give us a call at 1-877-313-2442 or use one of the contact forms to start the ball rolling.
FREE Seed-to-sale Software Buyer's Guide
Record keeping is an essential part of Health Canada’s compliance regulations. From the advent of legal medical marijuana in Canada, legal producers of cannabis have been required to track every seed, rooted plant, gram of waste material, final dried product, as well as interactions with customers and more. Due to the sheer volume of information, an electronic record-keeping system is the only practical way to manage the process. The software industry has responded to this need by creating seed-to-sale management software systems designed to help producers track their operations and report to Health Canada to meet compliance.
To help you through the process of purchasing seed-to-sale software in the Canadian Cannabis marketplace, we’ve produced a 20-page guide that answers the following questions:
- What is a seed-to-sale software solution and why do I need one?
- How do I choose one software platform over another?
- What should I be looking for in the software?
- How does the software fit into my business?
- How is my data stored and secured?
- What happens if regulations change?
To download this guide courtesy of AirMed, please visit the following page and complete the form. Once you submit the form, you’ll be able to download the guide.
What We Heard Report
The federal government released a report that summarizes what a “five-person expert panel has heard over the past year as it engaged with almost 500 stakeholders in nearly 90 meetings across Canada.”
The report, titled “What We Heard,” describes the scope of the engagement and summarizes the responses in several categories including: public health, impact on young persons, impact on First Nations and more.
Read about the expert panel and review here: https://www.canada.ca/en/health-canada/services/drugs-medication/cannabis/laws-regulations/cannabis-act-legislative-review/expert-panel/legislative-review-cannabis-act-report.html
Read the report here: https://www.canada.ca/en/health-canada/services/drugs-medication/cannabis/laws-regulations/cannabis-act-legislative-review/expert-panel/legislative-review-cannabis-act-report.html
Stratcann summarized the report in an article published on their website on October 10, 2023, the same day the report was released.
Read the Stratcann article here: https://stratcann.com/other/canada-releases-what-we-heard-report-on-the-cannabis-act-review/
Global News followed up the release of the report with an in-depth article on the state of the cannabis industry in Canada. In the feature published on October 16, 2023, Global News offers commentary by several experts including George Smitherman, president and chief executive of the Cannabis Council of Canada.
Read the Global News article here: https://globalnews.ca/news/10027112/cannabis-act-review-canada/
Health Canada Seeks Your Feedback from March 25 to May 24, 2023
In relation to a consultation on potential amendments to the Cannabis Regulations, Health Canada is seeking feedback and comments on potential amendments to the Cannabis Regulations.
The aims of the consultation include clarifying existing requirements, eliminating regulation inefficiencies and duplications and reducing administrative and regulatory burdens, and Health Canada is seeking input from:
- cannabis industry stakeholders
- public health stakeholders, non-governmental organizations
- researchers and research or academic institutions
- First Nations, Inuit and Métis partners and organizations
- law enforcement
- provincial, territorial and municipal governments
For more information including how you can provide feedback until May 24, 2023, visit:
https://www.canada.ca/en/health-canada/programs/consultation-potential-amendments-cannabis-regulations.html
What to Expect from the Cannabis Act Review
Since the announcement of the Cannabis Act review, people are speaking out about what they hope to see from reviewers.
The review was initially planned to begin in 2021 and look at the public health implications of the legalization of cannabis in Canada.
The CBC reported that the government delayed the start of the review to expand the scope. “The review mandate has been expanded to include an examination of the social and environmental effects of the Cannabis Act, the impact of legalization and regulation of medical cannabis and the impact on racialized communities and women.”
Read more here: https://www.cbc.ca/news/politics/public-health-cannabis-mandated-eview-1.6591442
An article in The Globe & Mail stated that “For George Smitherman, the chief executive officer of the Cannabis Council of Canada, the national industry association, the announcement comes at a critical time. Companies continue to face pressure from the illicit market, as well as excise taxes, provincial distributor markups and regulatory fees.”
Read more here: https://www.theglobeandmail.com/business/article-health-canada-cannabis-act-review/
The Toronto Star notes that the pot sector wants packaging changes and financial relief from the review. “The industry is frustrated the review’s launch arrived a year later than mandated but is still hoping it can result in enough tweaked restrictions to make cannabis distribution easier, draw in new customers and prevent more staffing and facility cuts.”
Read more here: https://www.thestar.com/news/cannabis/2022/09/22/pot-sector-wants-packaging-changes-financial-relief-from-cannabis-act-review.html
The review is expected to be completed in 18 months, and government officials say that it will consider health issues as well as financial, tax, regulatory and criminal-justice matters.
Government of Canada Launches Cannabis Act Review
On September 22, 2022, the Government of Canada announced the launch of a legislative review of the Cannabis Act.
The announcement stated, “Parliamentarians recognized the need for an early assessment of the Government’s new approach to cannabis control, and included a provision requiring a review in the Act. The review will help ensure that the Act adapts to the current situation and continues to meet Canadians needs and expectations.”
An independent panel of experts will lead what is being called a credible and inclusive review. “The Panel will provide independent, expert advice to both Ministers on progress made towards achieving the Act’s objectives, and will help identify priority areas for improving the functioning of the legislation.”
In conjunction with the legislative review, an online engagement process has been launched.
All Canadians are invited to read Taking Stock of Progress: Cannabis Legalization and Regulation in Canada.
Canadians are also encouraged to share their views via the online questionnaire or through written feedback until November 21, 2022.
Take the survey here: https://ca1se.voxco.com/SE/?st=3KoT2Xgsv4uHJF2%2F0i%2F7oo5IS3ATejUCjIjdJ4lUsME%3D&lang=en
You can also read the original announcement on the Government of Canada website.
AirMed Compliance Documents for Health Canada Cannabis License Applicants
The Cannabis Act requires that license applicants provide information on how they expect to meet certain compliance requirements.
We offer full support throughout your license application process and provide documentation that outlines how AirMed meets Health Canada requirements. If you plan to use AirMed for compliance after you are licensed, you submit the documents we supply as part of your application. We also partner with specialists in licensing applications and business management if you need more help.
For applicants who expect to use AirMed to help meet compliance, we provide two comprehensive documents designed for submission with license applications.
AirMed Record Keeping Compliance: This document provides an overview of how AirMed provides support to enable a licensed producer to be compliant with the record keeping & reporting requirements of the Cannabis Act and Regulations (CAR) and the former Canadian Access to Cannabis for Medical Purposes Regulations (ACMPR). This document is intended to assist compliance auditors and internal compliance leaders in assessing readiness in relation to CAR requirements, as well as security and privacy standards.
AirMed Good Practices Compliance: This document provides an overview of how AirMed provides support to enable a licensed producer to be compliant with the good practices requirements of the Cannabis Act and Regulations (CAR).
For more information or to purchase our compliance documents, please call 1-877-313-2442 or email info@airmed.ca. You can also fill out the contact form in the footer.
For more information on how AirMed helps you meet compliance, visit our Compliance page or our Frequently Asked Questions page.
Why you need seed-to-sale software for your cannabis business
Introduction
Seed-to-sale software tracks plant production from reproduction through growth, harvesting, drying, packaging, sales and distribution. Health Canada mandates record keeping for every part of the process, and Canadian seed-to-sale software applications focus on compliance built on Health Canada’s regulations.
Record keeping is an essential part of Health Canada’s compliance regulations. From the advent of legal medical marijuana in Canada, legal producers of cannabis have been required to track every seed, rooted plant, gram of waste material, final dried product, as well as interactions with customers. Due to the sheer volume of information, an electronic record-keeping system is the only practical way to manage the process. The software industry has responded to this need by creating seed-to-sale management software systems designed to help producers track their operations and report to Health Canada to meet compliance.
As a Health Canada applicant, you must specify the name of the software system you plan to use for record keeping and provide a summary of how the software program meets Health Canada’s requirements. As a result, you will need to make at least preliminary decisions into seed-to-sale management software early on in your application process.
This might seem like one more challenge along your path to becoming a licensed producer, but in reality, seed-to-sale software is designed to help you be successful.
Seed-to-sale software platforms should provide the electronic record keeping required to not only for you to meet compliance, but also to help you be successful in your business. From greenhouse to warehouse to customer, your software system should help you at every stage of your operation. Functionality for genetics tracking, inventory management, quality control, shipping & receiving, point-of-sale ecommerce, compliance auditing & reporting, and customer relationship management can provide you with full business administration.
Licensing
To do business in the cannabis industry in Canada, you must meet Canada’s licensing requirements. Currently there are several types of licenses for those wishing to carry out cannabis-related business in Canada.
- Standard Cultivation
- Micro-cultivation
- Nursery
- Standard Processing
- Micro-processing
- Sale
- Analytical Testing
- Research
Regardless of which class of license you get, you will be responsible for complying with all the regulations that apply from the various levels of government.
The Laws
The Cannabis Act
Formerly called the ACMPR, this act covers all aspects of cannabis in Canada from growing through processing to selling and more. It is the responsibility of the licensee/applicant to understand and meet all the requirements that apply to their business.
Other Federal Acts and Regulations
As a licensee or applicant, you are responsible for complying with requirements of other Canadian acts and regulations such as the Food and Drugs Act (FDA), the Pest Control Products Act, the Fertilizer Act, among others.
The Canada Revenue Agency
You’ll also need to meet requirements of the Canada Revenue Agency depending on which activities will be conducted with cannabis.
Provincial or Territorial Legislation
As a licensee or applicant, you’ll be responsible for complying with all applicable provincial or territorial laws and regulations (environmental laws, for example).
Municipal By-Laws
As well, you’ll need to deal with municipal by-laws such as zoning and building permits.
How can seed-to-sale software help?
From the advent of legal medical marijuana in Canada, legal producers of cannabis have been required to track every seed, plant, gram of waste material, final product, and more. Due to the sheer volume of information, an electronic record-keeping system is the only practical way to manage the process.
The software industry has responded to this need by creating seed-to-sale management software designed to help businesses meet compliance. Seed-to-sale software tracks growth, harvesting, processing, packaging, sales and distribution.
And some seed-to-sale software systems go beyond compliance to help businesses cultivate success with features and functionality to help fine-tune propagation, growth cycles, harvesting, production, derivatives, inventory, staffing, and product sales. AirMed is one of those. Wherever your business fits in the seed-to-sale supply chain, AirMed can help with both legal compliance and business acumen. For a free demo, call 877-313-2442, email info @ airmed.ca or fill out the form on our contact page.
For information on cannabis licensing in Canada visit: Cannabis Licensing Application Guide
For more information on purchasing seed-to-sale software, fill out a form to download our complete buyer’s guide: Seed-to-sale Software Buyer’s Guide
New AirMed version lays groundwork for October 17 Cannabis Act changes
A new version of AirMed seed-to-sale software was released October 16, 2019. This is a substantial build that lays the groundwork for the October 17 changes to the Cannabis Act and CTLS reporting.
The new version offers significant updates to the Received Products section of the cloud-based application including the ability to receive into the facility any type of product (edibles are coming soon) either bulk or packaged. The system now allows product to be transferred to a processor and packaged up, then the packaged material can be received back into the facility.
For received products, users now have the ability to add items to an existing lot, back-date inventory adds, and update finished/unfinished designation for new Health Canada regulations. We’ve also added an extraction material type category for new Cannabis Tracking and Licensing System (CTLS) reporting requirements, plus the ability to move all plants in batch and print a timeline report for batch details.
If you are a current AirMed customer, please explore the new features in your sandbox service, and let us know if you have any questions by contacting your customer service representative.
To learn more about the Cannabis Act in Canada visit: What you need to know about cannabis – Canada.ca
For more information on how AirMed helps your cannabis business, visit our Software page or our Frequently Asked Questions page. If you’d like to discuss your specific needs, please give us a call at 1-877-313-2442 or use one of the contact forms to start the ball rolling.
Legalization of Cannabis in Canada
As of October 17, 2018, cannabis is legal in Canada for both recreational and medical use. If you want to know exactly what that means for you, there are plenty of articles available online to help you. Following are a few from Canada and around the world:
CBC News: Cannabis is legal in Canada — here’s what you need to know
CNN: Canada just legalized recreational pot. Here’s what you need to know
Pot 101: Everything you need to know about marijuana legalization
New York Times: Canada is Legalizing Marijuana. Here Are Some Questions, Answered.
Prohibition 2.0 Begins October 17, 2018