Article by High! Canada
When it comes to technology breaking down the walls between ACMPR compliance and cannabis through its software initiatives we wanted to talk to the best. High! Canada Magazine had the opportunity to speak to Cannabis OneFive aka C1-5 who is the only licensed, technology partner with access to Veeva QualityOne software in the world. The C1-5 solution brings compliance and efficiency together; delivering quality management and document control that is Part 1, Division 5 compliant (ACMPR), FDA 21 CFR Part 11 compliant and EU Annex 11 compliant. So, why should anyone modernize their Quality Management System?
As we see it, many manufacturers are reaching a turning point regarding their quality and document management systems. Faced with the need to automate paper-based systems or replace outdated legacy systems due to an increasingly complex business environment, the majority of manufacturers are either planning for or actively considering, a modern quality management system (QMS). While no technology solution, cloud or otherwise, is a silver bullet, cloud solutions are increasingly the QMS mode of choice among major manufacturers across industries.
Tell us a little more about Cannabis One Five?
We are a technology partner with the largest and fastest growing global Life Sciences software company in the world, Veeva Systems (US $8 billion: NYSE). Cannabis OneFive has designed Veeva QualityOne & Vault specifically for the Canadian cannabis sector.
Vault QualityOne is a cloud-based Quality Management & Document Management software solution that meets the requirements of Part 1, Division 5 of the ACMPR (where our company name is derived from). The software is also FDA and EU Regulations compliant, making it an especially good fit for companies with global aspirations and is designed to make you Inspection and Audit-Ready for when Health Canada comes knocking.
The beauty of the software lies not only in helping you dodge fines and product seizures from HC but by increasing control, visibility, and accountability with internal and external stakeholders (like suppliers). Unlike ERPs, which automate quality functions in the supply chain (think manufacturing, product, and process data), QMS automates quality functions across the entire company (think recording, management, and resolution of incidents across all depts.), effectively fostering a culture of compliance. This enables you to focus on what you do best – cannabis production, testing, research, distribution etc. Furthermore, we will be adding edible and beverage modules to our software as they are introduced to the market in 2019. In short, we’re real and we can absolutely help LPs, Applicants, Distributors and Laboratories reach the next level with pharma-grade compliance.
Finally, here’s a nice and easy way to think of where we fit in the ‘Compliance Chain’:
1. Health Canada and the ACMPR tells you WHAT you must do
2. SOPs tell us HOW you must do
3. C15 PROVES you did it in a compliant fashion & produces audit-friendly trail – our QMS is a value-added complement to any ERP Seed-to-Sale system.
Thank you for breaking it down for us!