The audit evaluated Ledidi’s Quality Management System, software development lifecycle, SaaS operations, and core system functionality.
The independent auditor concluded that Ledidi has implemented a comprehensive and well-structured quality system, with controlled and traceable agile development practices, formal release and change management processes, and robust operational controls for security, data integrity, backup, disaster recovery, and business continuity.
In addition, Ledidi Trials was confirmed to meet supplier-side regulatory expectations for electronic records, audit trails, role-based access controls, and electronic signatures, supporting compliant use in regulated clinical studies.
The final report contains no open deviations or recommendations.
While responsibility for system validation and intended use remains with the regulated organisation, the audit report and supporting documentation may be leveraged by sponsors and CROs as part of their vendor qualification and due diligence activities, in line with ISPE GAMP 5 guidance.
This audit represents an important milestone in Ledidi’s ongoing commitment to delivering secure, compliant, and audit-ready software for modern data-driven clinical research.
If you like to know more about the Ledidi Trial solution:
Request the Audit Report https://ledidi.com/trust-centre
Get in touch with our clinical trials team https://ledidi.com/request-a-demo