21 CFR Part 11 e-signatures
Approvals re-ask the password, record the meaning and bind a hash of the signed content.
TMSGxP training management
Keep every person trained, assessed and signed off.
Galax TMS manages GxP training from material to signed record. Create trainings with materials and scored assessments, assign them by department, designation or group, run instructor-led sessions with attendance, and capture electronic signatures on completed training. Training records, job descriptions and CVs are kept with a read-only audit trail and PDF reports.
- 6
- Training statuses tracked automatically
- e-Signed
- Training records
- Training reports and attendance sheets
Capabilities
Keep every person trained, assessed and signed off.
6 capability areas, all running under the same role-based access, electronic signatures and audit trail.
- 01
Trainings & materials
Build and maintain the training library.
- Draft, Active, Inactive and Archived trainings
- Materials in multiple formats with preview and download
- Duplicate, assign and archive trainings
- 02
Question bank & assessments
Check understanding with scored assessments.
- Single-choice, multiple-choice and true/false questions
- Marks, mandatory questions and explanations
- CSV import and export; preview
- Configurable pass mark and maximum attempts; results locked
- 03
Assignments
Assign the right training to the right people.
- Assignment by department, designation or group
- Summary before save and duplicate-assignment warning
- Due dates with due-soon and overdue notifications
- 04
Instructor-led sessions
Classroom, online or on-the-job sessions with attendance.
- Session scheduling with venue, mode and attendees
- Attendance confirmed with the trainer's e-signature
- Attendance sheet PDF
- 05
Electronic signatures
Sign completed training as a Part 11-style record.
- Drawn or typed signature matching the registered name
- Signature meaning and acknowledgement
- Electronic signature log in the training record
- 06
Records & reports
Inspection-ready training evidence.
- Per-user training profile with filters
- Job descriptions and versioned CVs
- PDF training reports, CSV export and print
- Read-only audit trail and Read-only Auditor role
How it works
One accountable path from set-up to evidence.
Galax TMS runs on the same users, roles, e-signatures and audit trail as the rest of the Galax platform.
- 01
Create
Add training material and the assessment.
- 02
Assign
Assign by department, designation or group.
- 03
Train
Self-paced review or instructor-led session.
- 04
Assess
Automatic scoring against the pass mark.
- 05
Sign
e-Sign the record and report it.
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
- Training manager
- Trainer
- Employee
- Auditor
- Quality assurance
Contact
See Galax TMS on your protocol.
Share your protocol synopsis, current workflow or delivery gap. We will respond with an achievable configuration and validation approach.