Part 11 sets rules for electronic records and signatures, not a badge a vendor can hand you. Here is each requirement in plain language and the specific control that meets it.
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
4
fields logged on every change: user, time, old value, new value
2
signature steps: participant sign, then countersign
3
access roles: researcher, site coordinator, admin
0
ways to edit the audit trail from the app
The regulation
The FDA rule says electronic records and signatures can stand in for paper and ink, provided the system meets specific controls and the sponsor validates their own use of it. No agency certifies software as Part 11 compliant. What you can check is whether a system gives you the controls the rule actually asks for.
Edit checks / auto-queries
2Type
Range High
Operator
Greater than
Value
180
Priority: High
Type
Range Low
Operator
Less than
Value
80
Priority: Normal
Query raised automatically
Value 192 violates limit (180). Please verify.
The checklist
Walk any vendor, Capture included, through this list before you rely on their claim.
Who changed it, when, the old value, the new value and the reason, on every field.
Recorded by the database, not the browser. No admin setting turns it off.
Email OTP verification plus a legal-binding acknowledgment before the signature is captured.
Researcher, site coordinator and admin roles, each seeing only what their role needs.
Every user signs in as themselves, so every action is attributable.
Available on Enterprise plans to support your Part 11 validation and UAT.
Signatures
Part 11 signatures need to survive a challenge: prove the signer, prove the moment, and prove the document has not changed since. Capture verifies the participant by email one-time passcode, then requires an investigator or authorized staff member to countersign with a password before a consent is treated as final.
Blank eCRF · no subject data
Visit by form matrix
| Form | SCR | D1 | W2 | W4 | W8 | EOS |
|---|---|---|---|---|---|---|
| Demographics | X | |||||
| Vital signs | X | X | X | X | X | X |
| Laboratory | X | X | X | |||
| ECG | X | X |
3. Was the ECG performed?
☐ Yes☐ No
If No, complete question 4.
The difference
Build a free sandbox study, make a few edits, and look at the audit trail entries directly.
No. Part 11 is an FDA regulation that sets requirements for electronic records and signatures. There is no FDA certification for software; a sponsor validates their own use of a system against Part 11 and their SOPs.
Who made the change, when, the value before and after, and the reason for the change, on every field, without the ability for a user to edit or clear that history.
Yes. Capture provides a field-level audit trail that cannot be edited from the UI, electronic signatures verified by OTP and countersignature, and role-based access control. Documentation to support your own validation is available on Enterprise.
Yes. Part 11 compliance depends on how you configure and use a system, not only on the software. Most teams complete a lightweight validation and UAT pass even on a vendor-supplied platform.
Part 11 is an FDA regulation covering electronic records and signatures. ALCOA+ is a data-integrity framework used across GCP more broadly. A good audit trail and signature workflow tend to satisfy most of both at once.
Yes. The free sandbox includes full audit trail and e-signature functionality with sample data, no credit card required.
Keep exploring
ALCOA+ data integrity checklist
The data-integrity framework behind most Part 11 audits.
Audit trail software
How field-level logging works in detail.
Electronic signatures for clinical trials
The full signature and countersignature workflow.
CRF builder for clinical trials
Where edit checks and validation rules live.
eConsent software
The consent workflow the signature rules protect.
ICH E6(R3) guide
The GCP guideline update running alongside Part 11.
Build a free sandbox study and check the audit trail and signature flow yourself.