Software Validation for Cannabis Processors

One of the challenges for cannabis processers is that regulations require them to validate their extraction practices. In many cases, those practices involve the use of software. Therefore, any software used in relation to production must be validated along with the practices.

As tracking production reliability is an important part of meeting compliance, most tracking involves the use of software.

Software vendors are responsible for ensuring the software the sell works as described. But, validating that software is the responsibility of the processor. Why? Because every organization operates differently, and validation must be done in relation to actual production practices.

If you are using AirMed as your system-of-record, you will need to validate our software as it is used in your facility.

AirMed helps you through the validation process by providing test scripts that can be used to validate each task in the workflows that relate to extraction processes. These test scripts show what the software was designed to do, how the software should be used for that specific task and what the end result should be.

We can also provide you with a validation report outlining how we meet software vendor compliance. Our validation report also details how our software complies with security, privacy and accessibility requirements. AirMed software has been designed to not only meet compliance with Canada’s Cannabis Act but also to support and comply with Federal and Provincial privacy legislation and regulations (PIPEDA, PIPA, PHIPA, PHIA). AirMed also meets the standards outlined in the US FDA 21 CFR Part 11, which many other specifications are based on.

We can also provide information on the standard operating procedures we use internally as well as how our software is developed and tested for quality assurance. Our internal procedures have been through an external vendor audit for the pharmaceutical industry and passed with no observations.

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.


Role-based Management in AirMed

Role-based management in AirMed helps control employee access to the software system.

Actions within AirMed are linked to roles. When you assign a role to an employee, you allow access to those actions.

Employees can be assigned to the roles that correspond to the requirements of their jobs. Employees not assigned to specific roles are prevented from accessing the associated workflows.

For example, if a staff member is new and working in cultivation, you can create a role that only provides access to certain actions in the Source Material, Batch, and Lot Details screens. All other action items will not be visible. This lets you restrict access to parts of the system, based on a user’s job function within your organization.

AirMed has several roles defined by default, but you can create as many roles as required. You can also edit or rename existing roles to match your organization’s workflows. Within each role you can specify which actions are associated.

For more information about how roles can help you manage employee access, contact us today by using one of the contact forms or by calling 1-877-313-2442.

For more information on how AirMed helps you 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.


AirMed is still 100% Canadian owned

As US corporations buy up seed-to-sale software companies in Canada, AirMed is still 100% Canadian owned.

AirMed was created in 2014 to help Canadian licensed producers meet compliance at all levels of government. Continuously innovating since then, we believe that building a culture of quality is an important part of our customers’ success. This commitment to quality is why a growing list of cultivators, nurseries, processors, manufacturers, and dispensaries use AirMed.

We rely on industry requirements and customer feedback to drive AirMed development, rather than investor pressure. We encourage our users to tell us what matters most to them in a cannabis management system. This feedback helps guide us in adapting AirMed to improve efficiency, productivity and user experience.

Our goal is to provide a responsive solution that not only meets customer needs but anticipates them, regardless of the size or focus of your cannabis business. That has been our driving force for nearly eight years.

Contact AirMed for a demo today to see what homegrown can do for you. Call us at (877) 313-2442 or use the contact form in the footer of this page.

For more information about AirMed, visit our About page or our Frequently Asked Questions page. If you’d like to have a conversation about AirMed, please give us a call at 1-877-313-2442 or use one of the contact forms to start the ball rolling.


Support for GS-1 Barcoding Standards in AirMed

AirMed software offers full functionality for multi-level packaging with layered barcoding that meets GS-1 barcode standards. This is the standard required to sell to provincial government distributors.

Licensed producers who use AirMed can assemble retail-ready individual product packages using a ‘master case’ system and identify and track products at each packaging level.

AirMed software offers full SKU and barcode management that supports GS-1 barcoding standards. Pricing can be set at the package or master case SKU, and custom pricing can be set for specific SKUs by customer. The software offers features for creating and processing the orders as well as fulfilling and shipping them to provincial agencies.

Our master case processing lets you use layered barcoding for individual containers through to cases of multiple containers. The AirMed track-and-trace system allows retail packages to be traced to the lot or batch and ultimately back to the original genetic material. And AirMed has a comprehensive multi-step recall process that completely automates recalls if they are ever needed.

To schedule a live demonstration of AirMed Cloud software, call us at 1-877- 313-2442 or click the Request Demo button at the top of the screen.

For more information on how AirMed helps your 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.


Manage Plants Individually or by Group in AirMed

AirMed gives you the flexibility to choose whether to manage plants individually or in groups.

Individually managed plants allow for each plant to be tracked independently using its unique barcode. This method of tracking the plants offers full precision by providing detailed information about the individual plant and letting you perform actions on each plant separately. Plant actions are recorded by scanning the barcode associated with the plant using a tag or container label.

Individual management is usually reserved for small batches or for mother plants where tracking of the individual plant is beneficial. Group management is recommended for larger crops intended for harvest as the tracking is simplified.

Group-managed plants are recorded by counts and do not need to be identified by a unique barcode, so there is no requirement to print off labels for each plant. When selecting plants to perform an action at the batch level, a count of plants is recorded for either a table or a room.

Plants are propagated as part of a batch, and records are maintained through each grow phase such as drying or harvesting at the batch level. The production process ends with the creation of a lot, which is linked directly to the batch. Post-production, including bulk storage or packages, is also tracked by the batch.

By default, plants are individually managed until you make the decision to covert them to group management. AirMed lets you choose which method is the most appropriate and efficient while still maintaining accurate records.

To find out more about AirMed features like group management, call us today at 1-877-313-2442 or use one of the contact forms to request a free demo.


CTLS Reporting in AirMed

Always innovating to help our customers meet the regulatory challenges they face daily, AirMed offers a new automated system for CTLS reporting.

As mandated by the Cannabis Act, Health Canada requires that licensees submit a Cannabis Tracking and Licensing System (CTLS) report every month for every licensed site. This reporting applies to cultivators and processors (including micro, standard or nursery), as well as sellers of medical cannabis and provincial or territorial authorities, distributors and retailers.

Full Export

Using our new full export process, thousands of reported fields tracked by AirMed will automatically populate the standard spreadsheet template provided by Health Canada. Not only is the time required to complete monthly reports reduced, but the potential for human error often encountered in manual data entry is eliminated.

Summary Reports

AirMed also includes a suite of CTLS summary reports offering breakdowns of key fields with direct links to detailed reports. You can identify the values used to calculate a final total and also find the exact inventory records used to calculate those values, all from one page. Inventory validation has never been easier.

 

For more information or for a free demonstration of our automated CTLS reporting, please call 1-877-313-2442 or use on of the contact forms on the site.


Quality Assurance in AirMed

AirMed provides licensed producers with a complete framework to establish and validate a quality assurance system.

The AirMed QA system is based on pre-defined North American and European pharmacopeia.

The system tracks testing results for the samples taken at any stage of production and enables shipping of samples to third-party QA labs. Results and certificate of analysis documents are logged and used to determine if the material the sample was derived from is acceptable for sale. Test results are verified by an authorized QA person and a passed or failed status is assigned to each data point. The QA results are maintained in the system and can be referenced at any point to review the values.

From reviewing non-conformance to documenting and communicating findings, AirMed helps you maintain your desired level of quality. Tracking attention to detail for every process gives you total confidence in your product.

For more information about quality assurance in AirMed, visit our Software page.  You can also schedule a live preview of the software by clicking the Request Demo button at the top of the screen. Or give us a call at 1-877-313-2442.


Reporting & Auditing in AirMed

AirMed software is specifically designed to meet or exceed Cannabis Act regulations with full audit support capabilities and comprehensive reporting. AirMed regularly passes Health Canada inspections. For more information visit our Compliance page.

AirMed is designed to support and comply with federal, provincial and local legislation. In fact, AirMed meets the USA’s FDA 21 CFR Part 11 regulations. Considered to be some of the most comprehensive electronic record keeping specifications in the world, they are the basis for the standards set by many countries.

AirMed pulls all the required information for all government reporting, whether monthly, quarterly, or annually. Reports are built in for Cannabis Licensing & Tracking System (CTLS) and Canada Revenue Agency (CRA). Supporting sub-reports provide the necessary validation detail. Export data to other systems or print reports to retain the required information outside of AirMed as archived printed or electronic records.

Every action/workflow in AirMed is auditable, and built-in audit reports & forms provide complete product traceability. Inventory, recall, destruction and other reports can be generated as needed. Authorized site auditors can be given access to perform inspections of records. AirMed retains all data indefinitely and lets you export or print reports to be held for required retention periods for audit purposes.

For more information about AirMed’s reporting and auditing features, schedule a free demo by clicking the Request Demo button at the top of the page or by using the contact form in the footer. You can also call us directly at 1-877-313-2442.


How Secure is AirMed Software?

AirMed seed-to-sale software is a Cloud-based platform hosted in a third-party, Tier 3, SSAE 18 SOC1/SOC2 compliant, hardened data center in Canada, and all data remains in Canada. The same data center is used by Canadian banks and government agencies to secure their web-based applications. All data in AirMed is protected by fully managed and monitored enterprise firewalls and intrusion detection/prevention systems.

All communication between the browser and the server is encrypted using SSL. Sensitive data is additionally encrypted while at rest in the database. When a barcode is scanned, the resulting code is input into a field within the web browser. This data is then encrypted and sent to the server for processing.

Administrators can configure access based on an employee security profile so that individual workers only have access to the functions and data that relates to their job responsibilities. Electronic signatures and multi-factor authentication ensure only authorized users can access information and complete tasks. Full audit trails for every record and every action in the system allows administrators to review changes anywhere at any time.

All data is backed-up both locally in the data centre for near-line recovery and to a secure offsite location in Canada for disaster recovery purposes.

To learn more about AirMed’s privacy and security, contact us today by using the contact form or by clicking the Request Demo button at the top of the screen. You can also give us a call at 1-877-313-2442.


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.


Implementing AirMed in Your Facility

As a cloud-based platform, AirMed does not require expensive dedicated hardware to operate. Producers are free to use any computing device that supports a web browser. As a result, set up consists mainly of configuring the software to meet your needs. The rest of the time involves learning to use the system and getting your employees up and running.

When you have completed your training, the next step is to configure your Live Production environment.
After you’ve configured and tested your system, it’s time to train other users (your workers) to use AirMed. Once users have been set up as Employees with usernames and passwords, they can access the AirMed Learn environment, which includes various training resources.

Employees can take additional training at a later date to develop skills for different areas of the system — in fact, anyone with access to AirMed can use the Learn environment at any time to learn about new features or refresh their knowledge.

When workers have completed training, you can configure their access to the system and they can get to work.

With AirMed you can implement only the functionality you need right now. For example, you can start by implementing the AirMed Grow module, then when you expand your operation, you add modules that meet your current needs for performing extractions, packaging for provincial sales, selling to medical patients or whatever your business entails.

Of course you will need some equipment in your facility such as weight scales, barcode scanners, and printers. You can choose whatever equipment you wish, but you can also use the AirMed Ecosystem.

To help our clients cultivate success, AirMed has developed strategic partnerships with leading vendors of seed-to-sale production equipment. Our AirMed Ecosystem lets you purchase hardware and software in a turn-key solution for your cannabis business.

We recognize that there is a dizzying selection of products to serve cannabis businesses. To assist our clients, we’ve scoured the market for industry-leading equipment that will help you operate at peak potential.
Each product selected for the AirMed Ecosystem is carefully chosen based on its ability to provide value, lower production costs and increase competitiveness for AirMed customers.

You create the package that’s right for you from pre-configured hardware and software. To learn more about the AirMed Ecosystem, visit the Ecosystem page.

For more information on how AirMed helps specific types of businesses, visit our Customers page or our Frequently Asked Questions page.

Ready to learn more about AirMed and to create the ideal technology ecosystem for your cannabis business? Click the Request Demo button at the top of the screen. You can also call 1-877-313-2442 or use one of the contact forms.


What happens with my seed-to-sale software if regulations change?

The market for cannabis is evolving. Health Canada manages oversight and sets the compliance requirements for legal production of cannabis in Canada. In the last five years, these requirements have changed multiple times and are set to change again with the legalization of cannabis for recreational use on October 17, 2018. A responsible software vendor will ensure that all its clients have the information they need to comply with the latest Health Canada requirements.

With SaaS or cloud-based seed-to-sale platforms, software updates are usually global to all clients/users. On-site implementations sometimes require individual upgrades performed by the client in conjunction with the vendor. Often this means scheduling both parties, which can delay access to the latest features and functionality. If there are modifications for specific clients, this can mean a complicated upgrade path with the risk of unintended software bugs and related down time or additional costs to re-customize.

As you choose your seed-to-sale software solution, be sure to consider the future of compliance and those implications on your business. No one knows for sure what the future holds, but history has shown that the only true constant is change.

For more information about the Cannabis Act in Canada visit: What you need to know about cannabis – Canada.ca

For more information, download our software buyer’s guide here: How to Purchase Seed-to-Sale Software


Take a look at our new interface!

A new version of AirMed Cloud seed-to-sale software was introduced at the Lift Expo this month in Vancouver.

AirMed is a cloud-based platform designed for licensed cannabis producers in Canada. The new version offers a more graphical interface and streamlined processes.
Originally designed to help licensed producers meet compliance, AirMed has evolved into a comprehensive business management solution for the Canadian cannabis industry.

"We've been developing AirMed since 2014, and no other seed-to-sale software offers the range of functionality we do," said Justin Hearn, President and CEO of AirMed Canada Systems Inc.  "AirMed keeps getting better, and this new interface is the icing on the cake. Not only does it look great, but this release streamlines many processes."

From cultivation and processing through shipping and receiving, AirMed covers all aspects of cannabis business management, including auditing and compliance reporting. From the moment genetics enter your facility, AirMed helps you manage every stage of your business. At every step, processes with compliance implications are streamlined into easy repeatable workflows, capturing the required data as part of doing business. The software provides a complete framework to establish and validate a quality assurance system. From reviewing nonconformance to documenting and communicating findings, AirMed helps you maintain your desired level of quality.

In fact, AirMed is the only business solution you need to manage production, sale and delivery of cannabis while meeting government regulations.

To schedule an AirMed software demo, email info @ airmed.ca or call 1-877- 313-2442.


What is seed-to-sale software and why do I need it?

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 ACMP (Access to Cannabis for Medical Purposes) 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.

What is ACMPR and how does it affect me?

What does ACMPR cover?

For the cannabis industry in Canada, the most critical compliance implications are those covered by the Access to Cannabis for Medical Purposes Regulations. This legislation covers every aspect of marijuana production and sale. Overseen by Health Canada, these regulations must be adhered to at every stage of cannabis business from propagation through to sale. As of August 24, 2016, the Access to Cannabis for Medical Purposes Regulations (ACMPR) replaced the previous Marihuana for Medical Purposes Regulations (MMPR).

ACMPR is designed to provide an immediate solution for Canada to meet legal requirements. But Health Canada is continuously evaluating how a system of medical access to cannabis should function alongside the government’s commitment to legalize, strictly regulate and restrict access to cannabis. As a result, laws and regulations may change.

Currently, the legislation contains four parts.

Part 1 sets out a framework for commercial production by licensed producers responsible for the production and distribution of quality-controlled fresh or dried marijuana or cannabis oil or starting materials (i.e., seeds and plants) in secure and sanitary conditions.

Part 2 sets out provisions for individuals to produce a limited amount of cannabis for their own medical purposes or to designate someone to produce it for them.

Parts 3 and 4 include transitional provisions, consequential amendments to other regulations, and provisions repealing the MMPR.

All those wishing to produce cannabis in Canada must apply to Health Canada to become a licensed producer under the ACMPR legislation, and all licensed producers MUST comply with the ACMPR regulations.

What are the specific ACMPR regulations that affect software and record keeping?

The ACMPR has many regulations that apply to the medical marijuana industry in Canada as a whole. Not all of those have implications for record keeping or to the method (software) used for that record keeping. (For links to the different websites that cover ACMP see More Information at the end of this document.)

How do I meet ACMPR compliance?

To be ACMPR compliant, your organization must have ways of meeting all of the regulations listed above.

Many of the regulations listed above apply to processes, so you’ll need to be utilizing best practices and documented standard operating procedures. You’ll also need to be able to prove to Health Canada that you have used best practices. That’s where seed-to-sale software comes in. Your cannabis business management software should provide you with the means to meet compliance when it comes to record keeping and reporting.

To support you in this process, a viable software vendor will supply you with a document that outlines exactly how the system they provide meets those requirements.

For more information on seed-to-sale software, download our buyer’s guide, which answers to the following questions.

What does seed-to-sale software cost?

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?

Download the buyer’s guide here: How to purchase seed-to-sale software

For a free demo to learn how AirMed meets these and other regulations, please call 1-877-313-2442, use clikc the Request Demo button or email info@airmed.ca.


AirMed's History

Back in 2014, a group of Canadian tech visionaries recognized the opportunities in the emerging cannabis industry in Canada and began building the AirMed software system.

AirMed’s founders have decades of experience in the technology sector with expertise creating business-to-business applications for highly regulated industries including pharmaceutical, healthcare, law enforcement and financial services.

Originally designed to help licensed producers meet compliance, AirMed has evolved into a comprehensive business management solution for the Canadian cannabis industry.

Named for the goddess of healing herbs, AirMed has become one of the leading seed-to-sale systems in Canada. With the introduction of the AirMed Ecosystem, AirMed offers a turn-key solution with integrated hardware and software to help producers become more productive and profitable.

For more information on AirMed, visit our About 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. You can also book a demo of AirMed by clicking the Request Demo button or using any of the contact forms.