Case Study: Global Medical Device Provider achieves FDA 21 CFR Part 11 compliance with Xybion ComplianceBuilder

Global Medical Device Provider - Customer Case Study

Global Medical Device Provider, a global leader in orthopedics, spinal care, sports medicine, and neurosciences, needed to close gaps in electronic signature and change authorization procedures. During an internal audit, the company found that project owners could change databases and flat files without proper approval or documentation, creating compliance risks around FDA 21 CFR Part 11, data integrity, access control, and auditability. To address these issues, the company turned to Xybion Corporation and its ComplianceBuilder solution.

Xybion Corporation implemented ComplianceBuilder to lock down file and database access, capture changes with audit trails, electronic signatures, and timestamps, and integrate with the customer’s existing IT and validation environment. The solution monitored specified folders and systems without moving or modifying the underlying data, minimizing disruption for researchers and eliminating the need to validate the entire system. As a result, Global Medical Device Provider improved regulatory compliance, reporting, and data integrity across multiple applications with minimal impact on operations and infrastructure.