Case Study: The Coordinating Center achieves secure, 21 CFR Part 11-compliant clinical trial information management with OpenText Content Server in the Cloud

Clinical Trial Information is Current, Protected, and Governed within FDA Regulations with OpenText Cloud-Delivered ECM

The Coordinating Center for a nationwide network of clinical research centers, a non-profit managing multicenter clinical trials, faced fragmented network drives and email-based collaboration that left critical documents insecure, without version control, audit trails, or a clear way to meet FDA 21 CFR Part 11 requirements—causing inefficiency, risk, and audit exposure.

They deployed OpenText Content Server in the OpenText Cloud, giving a secure, web-based ECM with permissions, full versioning, auditable histories, workflows and custom reports for offline site audits. The cloud-hosted solution enabled external access, simplified management, reduced paper and search time, improved productivity, and helped the organization pass regulatory audits while maintaining Part 11 compliance.

The Coordinating Center