Case Studies > Building a Compliant Foundation for Commercialization Success

Building a Compliant Foundation for Commercialization Success

Company Size
1,000+
Region
  • America
Country
  • United States
Product
  • Arena QMS
  • Arena Validate
Tech Stack
  • Cloud-based Quality Management System
  • Salesforce CRM Integration
Implementation Scale
  • Enterprise-wide Deployment
Impact Metrics
  • Customer Satisfaction
  • Productivity Improvements
Technology Category
  • Application Infrastructure & Middleware - Data Exchange & Integration
Applicable Industries
  • Healthcare & Hospitals
  • Life Sciences
Applicable Functions
  • Product Research & Development
  • Quality Assurance
Use Cases
  • Remote Collaboration
Services
  • Software Design & Engineering Services
  • System Integration
  • Training
About The Customer
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.
The Challenge
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.
The Solution
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.
Operational Impact
  • 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.
Quantitative Benefit
  • Speeds FDA Part 11 and Part 820 compliance.
  • Reduces compliance risks.
  • Accelerates collaboration to speed new product introduction.

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