Feature Development: FDA Audit Tracking and Reporting Systems

I drove the development of a robust audit tracking and reporting system within a configurable clinical research platform that supports remote patient data collection, as well as clinician and study staff researcher health data visualization. The new feature was designed to ensure compliance with digital clinical research practices and 21 CFR Part 11 standards mandated by the FDA.

The new feature includes an electronic signature system that captures essential details such as who made changes, when changes were made, and the reasons behind study modifications, which aligns with the rigorous documentation requirements needed for digital clinical research.

Additionally, a complete audit service was created with robust encryption measures, ensuring data security and integrity while facilitating platform visualizations of audit reports. A permission-based system was implemented to control access to sensitive data within the audit reports, catering to the diverse roles of staff involved in a study and ensuring compliance with privacy standards.

Change history reports were developed to track alterations made at the participant, site, and study levels during active studies, providing a comprehensive audit trail for transparency and accountability.

Reports generated by the audit tracking system were also made exportable and could be accessed at both the study and site levels, in adherence to the recent updates in FDA guidelines for comprehensive audit tracking, empowering researchers and study staff with accurate and accessible audit information for informed decision-making and regulatory compliance.