21 CFR Part 11 e-signatures
Approvals re-ask the password, record the meaning and bind a hash of the signed content.
eCDTElectronic clinical data transfer
External vendor data, received, checked, reconciled and mapped.
Galax eCDT manages external vendor data under data transfer agreements: the agreed file format, schedule and variable specification, receipt of each vendor file, automatic checks, review and acceptance with an electronic signature, reconciliation with the EDC, vendor issues and queries, SDTM mapping, data cut-offs and the external-data sign-off for database lock.
- Every
- Transfer checked automatically on receipt
- QC + Live
- Separate test and production environments
- Signed
- Acceptance and lock sign-off
Capabilities
External vendor data, received, checked, reconciled and mapped.
7 capability areas, all running under the same role-based access, electronic signatures and audit trail.
- 01
Agreements & specifications
Agree each transfer with the vendor before the first file arrives.
- Vendor register and agreement register
- File format, schedule and load type per agreement
- Variable specification and EDC reconciliation rules
- Template library, specification comparison and vendor sign-off of versions
- Restricted (unblinded) agreements
- 02
Transfers & automatic checks
Each file is checked against the agreed specification.
- Rule catalogue applied to every received transfer
- Findings work list with waivers and re-runs
- Accept or reject a transfer with an electronic signature
- Changes, data and history of every transfer
- 03
Review & queries
Record-level review of vendor data with structured queries.
- Study edit checks on vendor data with tested versions
- Record-level data review and sign-off
- Data queries to the vendor, including Excel exchange
- 04
EDC reconciliation
Match vendor records to the EDC and keep current data clean.
- Reconciliation between vendor data and EDC records
- Current-data view across all transfers
- Vendor issue log with follow-up
- 05
SDTM mapping
Map vendor data to SDTM with controlled terminology.
- SDTM mapping register with proposed and approved mappings
- Controlled terminology value maps
- Validation and preview of the mapped dataset before export
- 06
Schedule & vendor performance
Know which transfers are due, late or missed.
- Transfer calendar with missed-transfer justifications
- Service levels, review turnaround and vendor reminders
- Vendor API keys, connection test and inbound log
- Vendor scorecard
- 07
Cut-offs & lock
Freeze what goes into each analysis and sign off for lock.
- Frozen data cut-offs
- Lock readiness for external data
- Encrypted data deliveries with download acknowledgement
How it works
One accountable path from set-up to evidence.
Galax eCDT runs on the same users, roles, e-signatures and audit trail as the rest of the Galax platform.
- 01
Agree
Set up the agreement, specification and schedule with the vendor.
- 02
Receive & check
Every file is checked automatically and findings are worked.
- 03
Review & accept
Review records, raise queries and accept with an e-signature.
- 04
Reconcile & map
Reconcile with the EDC and map to SDTM.
- 05
Sign off
Freeze cut-offs and sign off external data for lock.
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
- Data manager
- Vendor
- Database programmer
- Biostatistician
Contact
See Galax eCDT on your protocol.
Share your protocol synopsis, current workflow or delivery gap. We will respond with an achievable configuration and validation approach.