Entering a transitioning market with unshakeable quality credentials
公司规模
11-200
地区
- America
国家
- United States
产品
- Qualio
技术栈
- eQMS
- SharePoint
实施规模
- Enterprise-wide Deployment
影响指标
- Cost Savings
- Customer Satisfaction
- Employee Satisfaction
- Productivity Improvements
技术
- 功能应用 - 计算机化维护管理系统 (CMMS)
- 功能应用 - 企业资源规划系统 (ERP)
- 功能应用 - 产品生命周期管理系统 (PLM)
适用行业
- 医疗保健和医院
- 药品
适用功能
- 商业运营
- 质量保证
用例
- 监管合规监控
服务
- 系统集成
- 培训
关于客户
Kazmira is a Colorado-based manufacturer of hemp-based cannabinoid products, including CBD oils, tinctures, topicals, and edibles. The company is committed to producing high-quality products that meet stringent regulatory standards. Kazmira operates in a highly regulated industry, where compliance with various state and federal regulations is crucial. The company has a strong focus on quality assurance and continuous improvement, aiming to build trust with both customers and regulatory bodies. With a team dedicated to maintaining high standards, Kazmira sought to transition from a manual, paper-based quality system to a more efficient digital solution to better meet FDA cGMP requirements and streamline their operations.
挑战
The cannabis and CBD 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.
解决方案
Quality Assurance Associate 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. With a structured validation, train-the-trainer, and document migration approach, Kazmira could implement and begin applying Qualio quickly, transitioning to a fully digital quality platform within 4 weeks. Qualio gave Kazmira the control and visibility they needed for an optimal, cGMP-based cannabis quality system. Time saved for continuous improvement: With a lower time and cost burden for quality, Hanna and the Kazmira quality team are now free to focus on continuous improvement: accelerating towards FDA 21 CFR 111 compliance, ensuring colleagues are suitably trained, and strengthening their supply chain with better control of suppliers.
运营影响
数量效益
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