Case Study: SomaLogic achieves regulatory compliance and accelerated commercialization with Arena Solutions

Building a Compliant Foundation for Commercialization Success

SomaLogic is an AI-data driven proteomics company that measures thousands of proteins to deliver actionable health insights and improve clinical outcomes. To stay competitive and compliant in a highly regulated life‑sciences market, the company needed to fast‑track innovation and demonstrate adherence to regulations (FDA Part 11/820, GMP, ISO, EU). Their previous document‑focused system lacked visibility and traceability across the full product record, hindering new product development and regulatory readiness.

SomaLogic implemented Arena’s cloud-based, product‑centric QMS to link bills of materials, quality records, design files, changes, and issues in a single platform without heavy IT overhead. The solution enabled real‑time collaboration for dispersed teams, electronic change orders and signatures, dashboards for NCRs/CAPAs, and audit planning, and Arena Validate accelerated software validation for audit‑ready results. The outcome is a single source of truth that reduces compliance risk, speeds new product introduction, scales with growth, and helps SomaLogic meet regulatory requirements.

SomaLogic

Angenette Nordqvist

Senior Manager Quality Assurance