21 CFR Part 11 e-signatures
Approvals re-ask the password, record the meaning and bind a hash of the signed content.
eTMFElectronic trial master file
Every essential document, filed, reviewed and inspection-ready.
Galax eTMF holds every essential document of the study, filed by the TMF Reference Model: zone, section and artifact at trial, country or site level. Documents are uploaded, checked, approved where required and become Final. The eTMF measures completeness against the documents expected at the current study stage and scores inspection readiness.
- TMF RM
- Reference Model structure
- Scored
- Inspection readiness
- 6
- Access levels from Viewer to eTMF manager
Capabilities
Every essential document, filed, reviewed and inspection-ready.
6 capability areas, all running under the same role-based access, electronic signatures and audit trail.
- 01
Filing
Get documents into the right place quickly.
- TMF tree by zone, section and artifact at trial, country and site level
- Single upload, bulk upload and filing inbox
- Metadata, preview and version history
- Compare two versions of a document
- 02
QC, approval & workflows
Every document checked before it becomes Final.
- Standard QC and approval
- Dynamic workflows you build for your process
- Act on workflow steps with e-signatures
- Document queries
- 03
Completeness & requests
Know what is expected, missing or not applicable.
- Expected artifacts per study stage
- Missing and not-applicable tracking
- Document requests and automatic renewals
- 04
Inspection readiness
A dashboard that answers what needs attention now.
- Readiness score and attention list
- Multi-tab view, bookmarks and saved views
- Reports and audit trail
- 05
Sharing & export
Give controlled access to people outside the system.
- Shared links with expiry and temporary password
- Manage and revoke shared links
- Download the TMF as a ZIP
- 06
Reminders
Keep the team moving without chasing.
- Daily digest and reminders by e-mail
- Outbox and notification bell when e-mail is not configured
How it works
One accountable path from set-up to evidence.
Galax eTMF runs on the same users, roles, e-signatures and audit trail as the rest of the Galax platform.
- 01
Set up
Choose the stage and expected artifacts.
- 02
File
Upload, bulk-upload or file from the inbox.
- 03
QC & approve
Check, approve and finalise each document.
- 04
Close gaps
Request missing documents and resolve queries.
- 05
Inspect
Share, export and review readiness.
Quality and control
Designed for regulated clinical work.
Platform controls and documented procedures support the sponsor's validated, risk-based use.
Role-based access
Each role sees only the screens and actions it is permitted, per environment.
Tamper-evident audit trail
Every change is attributable, time-stamped and kept with before and after values.
Validated deployment
Released under documented IQ/OQ/PQ, on-premise or in your cloud.
Who uses it
- TMF manager
- CRA
- Clinical project manager
- Quality assurance
- Inspector (shared link)
Pricing
Licence fee.
Fees in USD, exclusive of taxes. Set-up and build fees are one-time and quoted separately.
Galax eTMF
Electronic trial master file
$1,500per month
$18,000per year
Request a quoteBuild a quote →Rate card GLX/RATE/2026-27/003.
Contact
See Galax eTMF on your protocol.
Share your protocol synopsis, current workflow or delivery gap. We will respond with an achievable configuration and validation approach.