Being audit-ready means every change to a record is already logged, timestamped and attributable, so nothing needs to be reconstructed after the fact. Capture’s field-level audit trail captures that automatically on every record, so an inspection is a matter of exporting what already exists.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Stage 1
DraftBuild and edit freely
Stage 2
ApprovedLocked for live use
Stage 3
In the casebookOnly approved forms
SDV requirement changed on Systolic BP
Data manager · Reason: critical safety value
Form approved: Vital Signs (VS) v2
Study owner · Locked for live use
Answer changed: Weight 68.0 to 68.5 kg
Site coordinator · Reason: transcription error
Field-level
audit trail on every record
0
ways to edit the audit trail from the UI
5
things captured per change: who, when, old, new, reason
100%
exportable, any time
A standing state, not a scramble
Teams that are truly audit-ready are not scrambling when an inspection is announced. The audit trail, e-signatures and role-based access were already running on every record from day one. Reconstructing history after the fact is the sign of a system that was not built for this.
Stage 1
DraftBuild and edit freely
Stage 2
ApprovedLocked for live use
Stage 3
In the casebookOnly approved forms
SDV requirement changed on Systolic BP
Data manager · Reason: critical safety value
Form approved: Vital Signs (VS) v2
Study owner · Locked for live use
Answer changed: Weight 68.0 to 68.5 kg
Site coordinator · Reason: transcription error
What inspectors check
Every change logs the user, timestamp and a reason for change.
Yes. The old value stays in the audit trail alongside the new one.
Each e-signature is cryptographically linked to the exact document content at signing time.
Role-based access with row-level security enforced at the database layer.
E-signatures
Participant signatures go through a two-step process including mandatory email confirmation, and investigators countersign with password re-authentication and a legal meaning statement. A document is only "Fully Executed" after that countersignature.
At-risk participants
Before you switch
The audit trail and e-signatures are included at every tier, not a paid add-on.
21 CFR Part 11-aligned controls throughout, with documentation available on Enterprise to support your own validation.
The audit trail runs automatically on every record from the moment you start building.
Bring an existing study across without losing your compliance posture.
Email support, typically under 24 hours.
Free sandbox with every feature. No credit card, no sales call.
A timestamped, attributable record of every change (who, when, old value, new value and reason), e-signatures tied to the exact document signed, and access limited by role. Capture captures all of this automatically on every record.
No. The audit trail cannot be modified from the UI, on any record.
Yes. The audit trail is always exportable.
Yes. Each repeating row carries its own field-level audit history.
Through a two-step process including mandatory email confirmation for participants, and password re-authentication with a legal meaning statement for investigator countersignature. Each signature is cryptographically linked to the exact document content at signing time.
It covers the audit trail and e-signature controls Part 11 calls for. See our Part 11 compliance checklist for the full picture, since compliance also depends on your own validated use of the system.
Keep exploring
Audit trail software
A deeper look at field-level logging.
21 CFR Part 11 compliance checklist
The full compliance picture beyond just the audit trail.
ALCOA+ data integrity checklist
The data integrity principles the audit trail supports.
Electronic signatures for clinical trials
How the e-signature workflow works end to end.
GDPR-compliant clinical trial software
The access-control side of the compliance picture.
Free sandbox with every feature. No credit card, no sales call.