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实例探究 > Achieving Closed-Loop Design Control Across the Organization

Achieving Closed-Loop Design Control Across the Organization

技术
  • 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)
  • 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
  • 预测性维护
  • 监管合规监控
  • 远程协作
服务
  • 系统集成
  • 培训
挑战
When evaluating solutions, Pulse Biosciences knew what they needed—one place for all product lifecycle and quality management processes. Guneet Bhogal, Quality Assurance Specialist, shares, “We wanted to have a closed-loop system with everyone collaboratively working on the same current product definition, through the same processes, to the same goals.” For medical device companies like Pulse Biosciences, predictability and consistency are not only good, but critical. Prior to implementing Arena, Pulse Biosciences’ product processes were paper-based, and the team expended extensive efforts to track everything manually and ensure compliance.
关于客户
Pulse Biosciences is a company that is pioneering a novel and proprietary platform technology called Nano-Pulse Stimulation (NPS). This technology uses nanosecond pulsed electric fields to induce cancer cells in tumors to die naturally by triggering the adaptive immune system response. The company is focused on providing drug-free treatments for some cancers, thereby reducing toxicology. To achieve this mission, Pulse Biosciences relies on Arena to manage all aspects of quality management processes, from BOM creation to design controls, device history file (DHF), records keeping, and training management.
解决方案
Pulse Biosciences implemented Arena’s full suite of solutions to manage their quality and product lifecycle processes. Arena helps with DHF, project management, supplier management, CAPA, and all quality actions like NCMRs and change control. The system also manages training, ensuring compliance and traceability. Collaboration and access anytime around the world are crucial for Pulse Biosciences, especially when team members are performing clinical trials or on vacation. Arena provides the necessary security and tracking for urgent changes, regardless of location. All employees, from the CEO to engineers to the clinical team, use Arena. The company also uses Arena Analytics dashboards for management review boards to track progress and identify areas for improvement.
运营影响
  • Arena has enabled Pulse Biosciences to transition from paper-based processes to a digital system, significantly reducing manual tracking efforts.
  • The system supports global collaboration, allowing team members to access and manage urgent changes securely from anywhere in the world.
  • Arena has improved compliance and audit readiness, with auditors appreciating the control and structure provided by the system.
数量效益
  • Training compliance improved to 97%+.
  • Enhanced traceability and analytics capabilities.
  • Improved training management and compliance.

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