Kazmira is a Colorado-based manufacturer of hemp-based cannabinoid products, including CBD oils, tinctures, topicals and edibles.
The cannabidiol market remains in a period of transition, teetering between legality and illegality on a state-by-state basis. In an immature market without widespread recognition, earning regulatory trust and proving quality with strong manufacturing processes is vital.
Kazmira operated a highly manual paper-based quality system supported by SharePoint and spreadsheets. Kazmira leadership felt that FDA cGMP requirements couldn’t be met with this approach, and in early 2021 the company began the search for a digital quality system which would allow them to:
Ditch cumbersome paper processes
Demonstrate industry-leading quality to customers and regulators
Slice the time and cost burden of quality and refocus quality into a competitive weapon
Quality Assurance Supervisor Hanna Fanous began working with a consultant and former FDA auditor to pinpoint the optimal eQMS.
Qualio was identified as the system which best balanced price and usability and which could best allow Kazmira to hit their quality objectives.
Kazmira became Qualio customers in 2021, and with a structured validation, train-the-trainer and document migration approach, Kazmira transitioned to a fully digital quality approach within just 4 weeks.
Qualio gives Kazmira the control and visibility they needed for an optimal, cGMP- and ISO 9001-based quality system.
Hanna and the Kazmira team now deploy a fully paperless eQMS for document, training, event and supplier management.
The team enjoy:
Faster access to quality information for day-to-day tasks and for sharing with auditors and customers
Boosted engagement with the quality system, with more employees than ever logging in to access documents and complete training tasks
The freedom to focus on continuous improvement and cGMP compliance, not time-heavy admin
Real-time traceability of quality events and compliance gaps
Kazmira is now the only ISO-certified industrial hemp processing company in the world, and plans to secure FDA 21 CFR 111 compliance as their next stepping stone to operational excellence.
As the CBD market expands and new regulations arrive on the horizon, Hanna and the Kazmira team have the confidence and quality reputation they need for long-term success.