Our system digitizes, automates, and safeguards clinical trial files, participant binders, and site logs, while providing remote monitoring for sponsors and CROs
Comprehensive system specifically designed to comply with FDA 21 CFR Part 11, ICH GCP E6(R3), and ANMAT Resolution 6677/2010, ensuring full compliance.
AuditTrail provides advanced document handling, version control and complete audit capabilities with enterprise security best practices.
The system retains all clinical trial documents even after study completion, in accordance with client-defined retention periods and applicable regulations.
Comprehensive Document Management System for Clinical Trials
Complete traceability and immutable record of all operations
Complete history of all actions per file with event filtering and CSV export. Integrated modal in PDF viewer.
Dedicated /Audit page with professional interface, advanced filtering by multiple criteria and real-time search.
Capture of login/logout, file upload and download, modifications, permission changes and all system operations.
User, IP, date/time, duration, result. Complete change tracking with before/after values in JSON format.
Ability to export audit records in CSV format for regulators and external audits.
Complete traceability for regulatory audits with chain of custody of all critical documents.
Pre-configured system with specialized structure for clinical trials according to GCP standards.
Adaptable design for desktop, tablet and mobile. Professional theme with corporate colors and clean design.
Interactive tables with sorting, filtering and pagination. Dynamic modals with AJAX loading. Informative tooltips and toast notifications.
Integrated viewer for PDF, Word, Excel and Image files with version navigation, informative sidebar with metadata, zoom and search controls, and direct download.
Upload protocols, version documents, review previous versions and download for offline review.
Remote document monitoring prior to site visits, ensuring smooth collaboration and faster study activation.
Manage permissions, monitor activity, configure folder structure and maintain compliance.
Access immutable records, verify traceability, review controls, and validate CFR 21 compliance, inspection-ready.