Achieving Commercialization and Compliance Success
公司规模
200-1,000
地区
- America
国家
- United States
产品
- Arena QMS
- Arena Validate
技术栈
- Cloud-based System
- Lifecycle Management System
实施规模
- Enterprise-wide Deployment
影响指标
- Customer Satisfaction
- Productivity Improvements
技术
- 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
- 生命科学
适用功能
- 产品研发
- 质量保证
用例
- 监管合规监控
- 远程协作
服务
- 云规划/设计/实施服务
- 系统集成
- 培训
关于客户
Potrero Medical is a highly regulated medical device company focused on developing innovative solutions for the early detection of critical illnesses. The company aims to transform patient care by creating a predictive technology platform that can identify critical conditions such as acute kidney injury. Potrero Medical operates in a stringent regulatory environment, requiring compliance with standards set by the International Standardization Organization (ISO), Food and Drug Administration (FDA), and European Union (EU). The company faced significant challenges in scaling its quality management processes to meet these regulatory requirements while preparing to commercialize its first product. With a mission to improve patient outcomes through advanced medical technology, Potrero Medical needed a robust and scalable quality management system to support its product development and compliance efforts.
挑战
As a highly regulated medical device company, Potrero needed to ensure compliance with the International Standardization Organization (ISO), Food and Drug Administration (FDA), and European Union (EU) to achieve commercialization success. “I was brought on to evaluate quality processes and systems as we prepared to launch our first product because we didn’t have a system that was robust enough for new product introduction and compliance processes,” stated Sanjay Banerjee, COO for Potrero Medical. “We had FDA clearance, but our product was not commercialized yet and our current manual processes would not scale or hold up to the scrutiny of audits.” Product and quality information was managed using paper-based processes where bills of materials (BOMs) were documented on paper and then uploaded into a manufacturing system. Engineering change orders (ECOs) were also reviewed manually with limited supplier communication. The team at Potrero needed a scalable quality management system (QMS) that could support their growing product development and compliance needs while helping them address and pass audits.
解决方案
Having prior experience using Arena QMS, Mr. Banerjee knew that Arena was the right fit for the company, stating: “Arena QMS is a true lifecycle management system that is better than the typical document-focused QMS solutions I have experienced. Being able to manage BOMs and changes along with quality processes is a major advantage.” Also, as a cloud-based system, Arena QMS didn’t require a huge IT infrastructure investment or a lengthy implementation. “We started engaging with Arena Solutions in January and by March we were live using the system,” said Banerjee. “We’re using Arena for all training management, supplier management, design controls, engineering change management, regulatory compliance, quality records, and operations processes.” Arena QMS connects quality records directly to the product design in a single system. This allows Potrero to document and track closed-loop quality processes for device master records (DMRs), design history files (DHFs), training records, and nonconformance reports (NCR) in context to the entire product record and BOM. “We have all the phases of design and development managed in Arena QMS,” stated Banerjee. “This includes secure access for our suppliers, which are located globally, allowing them to be notified immediately of any change and ensure their system is up to date.”
运营影响
数量效益
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