CFR Part 11 Compliance Report
Clinical trial data integrity summary — 0 audit events
CFR Part 11 Electronic Records Compliance Report
Clinical Trial Data Integrity & Audit Trail Summary
Report Generated
September 11, 2026 at 07:38 PM UTC
Reporting Period
All available records
Total Audit Events
0
Studies Affected
0
Field-Level Changes
0
Compliance Statement
This report documents all electronic record modifications to clinical trial data within the Alphiniti Atlas platform, in accordance with 21 CFR Part 11 requirements for electronic records and electronic signatures. The audit trail captures all create, update, and delete operations with field-level before/after values, timestamps (UTC), source system identification, and user attribution. The audit trail is append-only and computer-generated, satisfying §11.10(e) secure, computer-generated, time-stamped audit trails.
Change Summary by Action Type
0
0
0
Detailed Change Log
No clinical trial audit events recorded for the selected period.
Alphiniti Atlas — CFR Part 11 Compliance Report
Computer-generated · Append-only audit trail · September 11, 2026 at 07:38 PM UTC
Report ID: CTR-MTXD048Q
0 events · 0 studies