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Building a Compliant Foundation for Commercialization Success
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
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.
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.
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
数量效益
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