Case Study: Swan Valley Medical achieves confident audit readiness with Arena Solutions

Swan valley medical Faces audits with confidence

Swan Valley Medical, an FDA-regulated medical device company certified to ISO 13485:2016, needed a better way to organize objective evidence and manage quality records across a globally dispersed supply chain. Its manual, paper-based processes made it difficult to find critical documentation quickly, creating compliance risk and the potential for costly penalties. Swan Valley Medical turned to Arena Solutions and its Arena QMS to improve quality management and audit readiness.

Arena Solutions implemented a quality management solution that linked documents and records, streamlined product information management, and covered key QMS processes beyond document control and CAPA. As a result, Swan Valley Medical reduced time wasted searching for information, improved synchronization across operations and suppliers, and faced audits with greater confidence and less stress.

Swan Valley Medical

Michelle J. Potvin

Director