实例探究 > Building a Compliant Foundation for Commercialization Success

Building a Compliant Foundation for Commercialization Success

公司规模
1,000+
地区
  • America
国家
  • United States
产品
  • Arena QMS
  • Arena Validate
技术栈
  • Cloud-based Quality Management System
  • Salesforce CRM Integration
实施规模
  • Enterprise-wide Deployment
影响指标
  • Customer Satisfaction
  • Productivity Improvements
技术
  • 应用基础设施与中间件 - 数据交换与集成
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
  • 远程协作
服务
  • 软件设计与工程服务
  • 系统集成
  • 培训
关于客户
SomaLogic Inc. is a leader in AI-data driven proteomics technology. The company seeks to deliver precise, meaningful, and actionable health management information that empowers individuals worldwide to continuously optimize their personal health and wellness. With the ability to simultaneously measure thousands of proteins over a wide range of concentrations, SomaLogic’s groundbreaking platform is designed to help drive better insights and improved clinical outcomes.
挑战
To stay ahead in the highly regulated and competitive life sciences market, SomaLogic needed to fast-track innovation and demonstrate compliance with various industry regulations and standards. Previously, SomaLogic relied on a content management tool to maintain their product and quality records. Because that system primarily focused on document management, it did not provide SomaLogic visibility and traceability across the full product record. This made it harder for SomaLogic to drive compliance and meet their new product development and introduction (NPDI) goals.
解决方案
Arena provides SomaLogic a product-centric framework to manage quality processes. SomaLogic needed a system that they could easily adopt without the burden of a costly IT infrastructure or a lengthy implementation. They chose Arena’s cloud-based quality management system (QMS) for its ease of use and ability to scale with their growing business. Unlike traditional document-based systems, Arena QMS links all of SomaLogic’s product information and quality processes in a single platform. By managing linked relationships between bills of materials (BOMs), quality records, design files, and any changes or quality issues, this product-centric approach to QMS provides SomaLogic greater visibility, traceability, and control throughout the entire product lifecycle and reduces compliance risks. Consulting with Arena’s solution architects, customer success coaches, and other industry experts also enables SomaLogic to utilize Arena QMS to its full potential and keep their processes running smoothly.
运营影响
  • Drives compliant practices across dispersed teams.
  • Product teams can easily create, review, and approve electronic change orders through automated notifications and routings.
  • SomaLogic’s quality team leverages Arena Projects to develop internal audit plans and schedules.
  • Nonconformances are linked to the audit schedule for greater visibility and quicker issue resolution.
  • The quality team has developed a custom workflow in Arena to record and track injuries, exposure to hazardous substances, and other workplace incidents that impact employee health and safety.
数量效益
  • Speeds FDA Part 11 and Part 820 compliance.
  • Reduces compliance risks.
  • Accelerates collaboration to speed new product introduction.

Case Study missing?

Start adding your own!

Register with your work email and create a new case study profile for your business.

Add New Record

相关案例.

联系我们

欢迎与我们交流!
* Required
* Required
* Required
* Invalid email address
提交此表单,即表示您同意 IoT ONE 可以与您联系并分享洞察和营销信息。
不,谢谢,我不想收到来自 IoT ONE 的任何营销电子邮件。
提交

感谢您的信息!
我们会很快与你取得联系。