Electronic signatures that re-check the signer, an audit trail nobody can edit, server-set timestamps and access that expires on schedule. The controls Part 11 asks for are part of how Capture stores data, not a setting to switch on.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Meaning of signature
I have reviewed this adverse event and confirm the assessment of seriousness, severity and causality.
Signer
Dr. A. Ozola, PI
Password
••••••••••
SHA-256
hash chain across audit entries
0
edits or deletes allowed on the audit trail
90 days
password expiry, enforced on the server
7
study roles with their own permissions
Part 11 controls
A plain summary of the technical controls. Compliance also depends on your own procedures and validation.
Field-level audit written by the database, with who, when, old value, new value and reason.
Append-only audit trail with a per-study SHA-256 hash chain and a verify check.
Password re-entry at signing, with the signer, time and meaning of the signature stored.
Role-based permissions per study and site, with passwords that expire.
Timestamps and IP addresses set by the server, never by the browser.
Clinical data is soft-deleted only, and audit exports are filterable CSV.
E-signatures
Every signature asks for the password again, checked on the server. The record stores the signer, the time and the meaning of the signature, such as an investigator attesting to an AE assessment.
Meaning of signature
I have reviewed this adverse event and confirm the assessment of seriousness, severity and causality.
Signer
Dr. A. Ozola, PI
Password
••••••••••
Audit trail
Database triggers write the audit trail, one row per changed field. Updates and deletes are blocked, and each entry carries a hash of the one before it, so any tampering breaks the chain.
Weight changed 68.0 to 68.5 kg
Site coordinator · Reason: Transcription error
Query Q-0014 answered on Weight
Site coordinator · Reason: Source checked
Vital signs form locked
Data manager · Reason: Visit cleaned
Sign a form, change a value and read the audit trail in a free sandbox.
Access
Permissions follow the role matrix for every study and site. Passwords expire every 90 days, and an expired account can read but cannot write or sign until the password is changed.
Study owner
Builds and configures the study
Principal investigator
Oversees the site, signs off the casebook
Sub-investigator
Enters and signs clinical data
Study coordinator
Screens subjects, enters visit data
Monitor (CRA)
Verifies data, raises queries
Data manager
Reviews, freezes and locks data
Participant
Completes their own questionnaires
Capture provides the technical controls Part 11 requires: audit trail, electronic signatures, access control and secure timestamps. Full compliance also depends on your procedures, training and validation of your study.
The signer re-enters their password, which is verified on the server. The signature stores who signed, when and the meaning of the signature, and is linked to the record.
No. The audit trail is append-only: updates and deletes are blocked in the database, and entries are hash-chained so tampering is detectable.
Yes. Timestamps and IP addresses on audit entries are set by the server, not supplied by the browser.
The user can still sign in and read, but cannot write data or sign until they change the password. The block is enforced on the server.
The same controls, audit trail, signatures and access management, support Annex 11 expectations too. As with Part 11, your procedures complete the picture.
Clinical data is never hard deleted. Removed records are soft-deleted and remain in the audit history.
Yes. Everything described here is available in the free sandbox.
Keep exploring
Part 11 compliance checklist
Each requirement, in plain language.
Audit trail software
How the audit trail works in detail.
Clinical data management
Queries, freeze, lock and exports.
RTSM software
Signed dispensing and blinding.
Adverse event reporting
Signed AE and SAE records.
eCRF software
Data entry, queries and verification.
Platform overview
Everything Capture does.
Free sandbox with every feature. No credit card, no sales call.