21 CFR Part 11 e-signatures
Approvals re-ask the password, record the meaning and bind a hash of the signed content.
eCTDRegulatory submissions
Regulatory submissions from content plan to archive.
Galax eCTD Publishing prepares regulatory submissions in ICH eCTD v3.2.2 with the US FDA Module 1 and the EU Module 1. A submission moves through planning, authoring and QC, sequence building, validation, approval, publishing, gateway submission and acknowledgement, and finally archiving, with each step on its own screen.
- v3.2.2
- ICH eCTD with FDA and EU Module 1
- v4.0
- Readiness view
- Plan → Archive
- Full submission lifecycle
Capabilities
Regulatory submissions from content plan to archive.
7 capability areas, all running under the same role-based access, electronic signatures and audit trail.
- 01
Applications & sequences
Manage dossiers that span several studies and products.
- Applications and the application workspace
- Sequences with type, related sequence and status
- Current view and document lifecycle
- Studies and study tagging files
- 02
Content planning
Know which documents are needed and where they stand.
- Content plans from CTD templates
- Document statuses with automatic placement
- Gap view and Excel export
- 03
Document QC & reviews
Quality-check documents before they are published.
- QC checklist with sign-off and withdrawal
- Review cycles with comments, rounds and closure
- 04
Building a sequence
Assemble each sequence with full lifecycle operations.
- Sequence builder: add, replace, append and delete
- Cover letter and 5.2 tabular listing
- Generated XML
- 05
Validation, approval & publishing
Validate before anything leaves the building.
- Sequence validation with validation profiles
- Validation history, pass-rate trend and PDF/Word report
- Approve, return to draft and publish
- Publishing report
- 06
Planning & gateway
Plan submissions and record what the agency received.
- Submission planning with calendar and Gantt of sequences
- Gateway submissions and acknowledgements
- Technical rejection and re-submission
- 07
Reuse, archive & integrity
Keep the archive complete and verifiable.
- Find and reuse documents across sequences
- Archive export and package verification
- Integrity checks and publishing metrics
How it works
One accountable path from set-up to evidence.
Galax eCTD Publishing runs on the same users, roles, e-signatures and audit trail as the rest of the Galax platform.
- 01
Plan
Create the application and content plan.
- 02
Author & QC
Track documents through QC and review cycles.
- 03
Build
Assemble the sequence and generate the XML.
- 04
Validate & publish
Validate, approve and publish.
- 05
Submit & archive
Record the gateway submission, acknowledgements and archive.
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
- Regulatory publisher
- Regulatory affairs
- Document author
- Approver
Contact
See Galax eCTD Publishing on your protocol.
Share your protocol synopsis, current workflow or delivery gap. We will respond with an achievable configuration and validation approach.