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 provide you with a validation report outlining how we meet software vendor compliance. Our validation report 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.
Our internal procedures have been through an external vendor audit for the pharmaceutical industry and passed with no observations.
If you’d like to learn more about good production practices for cannabis in Canada, the Government of Canada has published GPP guidance information here: https://www.canada.ca/en/health-canada/services/cannabis-regulations-licensed-producers/good-production-practices-guide/guidance-document.html
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.