Case Study: SynCardia Systems achieves audit-ready compliance and streamlined document management with MasterControl

The Heart of SynCardia Electronic Document Management Solution

SynCardia Systems, maker of the FDA- and CE-approved CardioWest temporary Total Artificial Heart, faced growing pains as it expanded to dozens of implant centers worldwide. The company relied on a hybrid paper/electronic document-change process that required hand-stamped approval packets, manual routing, dispersed hard-copy storage and inaccessible legacy files—creating delays, risk of lost records and compliance exposure just as SynCardia was also implementing an ERP system.

SynCardia selected MasterControl’s integrated Documents, Forms and Training suite after an FDA audit and, with MasterControl Professional Services, installed and validated the system in three months. The web-based solution delivered 21 CFR Part 11 controls, electronic CAPA/NCR workflows, training management, global access and audit trails, enabling audit readiness, faster revision cycles and better accountability. External audits confirmed compliance (ISO 13485 and other standards), and employees now log roughly 2,600 monthly interactions across 30 users—reducing risk, saving time and lowering costs.

SynCardia Systems

Rodger G. Ford

Chief Executive Officer