Complete Audit Trail & 21 CFR Part 11 Compliance

21 CFR Part 11 Compliant

Complete Audit Trail for Every Action

Automatic, tamper-evident audit trails that capture every document interaction. Pass inspections with confidence.

21 CFR Part 11 Compliant EU Annex 11 Ready GxP Validated SOC 2 Type II Certified

Audit Trail Features

Every action automatically captured with timestamp, user identity, and detailed context

Timestamped Actions

Every action recorded with precise timestamps using secure, synchronized server time that cannot be modified.

User Attribution

Every entry tied to authenticated user identity with full details including name, role, and department.

Before/After Values

Complete record of what changed, including original and new values for every modification.

Tamper-Evident

Cryptographic checksums ensure audit records cannot be altered without detection.

Advanced Search

Quickly find any audit record by user, document, date range, action type, or any combination.

Export Ready

Generate inspection-ready reports in PDF, Excel, or secure electronic formats on demand.

See Every Document Action

Audit Trail - Protocol-2024-001.pdf
Timestamp User Action Details
2024-01-15 14:32:18 EST
MJ
Dr. Maria Johnson
Approved Final approval for submission
2024-01-15 11:05:44 EST
RS
Robert Smith
Edited Updated Section 4.2 - Safety Monitoring
2024-01-14 16:22:01 EST
LP
Lisa Park
Viewed Document viewed for review
2024-01-14 09:15:33 EST
JD
James Davis
Created Document uploaded from template

Inspection Ready, Always

Generate complete audit documentation in minutes, not days

What Inspectors Need

  • Complete document history from creation to current
  • Electronic signature verification
  • User access and permission records
  • System access logs
  • Change control documentation

What DNXT Provides

  • One-click audit report generation
  • Pre-formatted inspection packages
  • Secure electronic or printed formats
  • Real-time availability (no prep time)
  • Certified true copies with checksums
100%
Inspection pass rate
<5min
Report generation
0
Audit findings
99.9%
System uptime

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