Driving Quality Across Supply Chain to Highest Levels
公司规模
11-200
地区
- America
国家
- United States
产品
- IntraOp® Mobetron®
- Arena
- Arena Analytics
技术栈
- Arena Platform
- Arena Analytics
实施规模
- Enterprise-wide Deployment
影响指标
- Customer Satisfaction
- Digital Expertise
- Productivity Improvements
技术
- 分析与建模 - 预测分析
- 应用基础设施与中间件 - 数据可视化
- 功能应用 - 企业资源规划系统 (ERP)
适用行业
- 医疗保健和医院
- 生命科学
适用功能
- 产品研发
- 质量保证
用例
- 质量预测分析
- 监管合规监控
- 远程资产管理
服务
- 软件设计与工程服务
- 系统集成
- 培训
关于客户
IntraOp Medical Corporation is the pioneer in portable electron-beam Intraoperative Radiation Therapy (IORT). The IntraOp® Mobetron® has transformed cancer treatment by bringing radiation technology into the operating room, uniting radiation oncology and surgery. For patients and their families, this means markedly shorter treatment and recovery times, improved outcomes, greater comfort, and quality of life. To ensure the teams execute on product realization at the highest levels of quality and adhere to regulations, IntraOp uses Arena for their critical product and quality management processes.
挑战
As an FDA-regulated company, IntraOp must not only design and produce a complex product with electro, mechanical, and software components, but do so while meeting all FDA 21 CFR 820, EU Medical Device Directive (MDD), ISO 13485, Health Canada, and other regulations requirements. So IntraOp needed more than a system to manage all the product details, changes to product, and collaboration efforts with the teams. They also needed a quality management solution to ensure absolute regulatory compliance. IntraOp chose the Arena platform for both product and quality management. After IntraOp implemented Arena to manage the product and quality processes, the team took the next step to business analytics with Arena Analytics. They wanted Analytics to provide critical day-to-day insights into quality process progress as well as provide confidence that they can meet regulatory requirements.
解决方案
IntraOp chose the Arena platform for both product and quality management. After implementing Arena to manage the product and quality processes, the team took the next step to business analytics with Arena Analytics. They wanted Analytics to provide critical day-to-day insights into quality process progress as well as provide confidence that they can meet regulatory requirements. As An Nguyen, Director of Regulatory Affairs and Quality Assurance, shares, 'Information from the Arena Quality module, such as CAPA and nonconformances visualized through the Arena Analytics dashboard, allows us to monitor the up-to-date performance of our product process, see the areas and suppliers which have unfavorable quality trends, and plan for our improvements or preventive actions.' Before implementing Arena Analytics, IntraOp depended on lengthy, labor-intensive manual data crunching to see what was happening with quality processes. 'Before Arena Analytics, we had to export quality process information to Excel, then use pivot tables and charts to manually create dashboards. Now, with Analytics we monitor quality performance and see our up-to-date progress automatically. The value of Arena Analytics is very high,' explains An.
运营影响
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