21 CFR Part 11 e-signatures
Approvals re-ask the password, record the meaning and bind a hash of the signed content.
eQMSElectronic quality management
Quality management for regulated clinical operations.
Galax eQMS is an electronic quality management system for regulated organisations. It manages quality risk with an FMEA model, keeps controlled documents in secure storage, and can be deployed on-premise or in the cloud.
- FMEA
- S × O × D risk model
- 1–10
- Scales with risk priority number
- Cloud or on-prem
- Deployment
Capabilities
Quality management for regulated clinical operations.
3 capability areas, all running under the same role-based access, electronic signatures and audit trail.
- 01
Risk management
Assess quality risks consistently.
- FMEA with severity, occurrence and detection on 1–10 scales
- Risk priority number (RPN) for each risk
- Risk register
- 02
Controlled documents
Keep quality documents under control.
- Controlled document storage
- Secure object storage for files
- 03
Deployment
Run it where your quality system needs to be.
- On-premise with Docker
- Cloud deployment on AWS
How it works
One accountable path from set-up to evidence.
Galax eQMS runs on the same users, roles, e-signatures and audit trail as the rest of the Galax platform.
- 01
Identify
Record the quality risk.
- 02
Score
Rate severity, occurrence and detection.
- 03
Prioritise
Use the RPN to decide actions.
- 04
Control
Keep the supporting documents controlled.
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
- Quality assurance
- Quality manager
- Process owner
Contact
See Galax eQMS on your protocol.
Share your protocol synopsis, current workflow or delivery gap. We will respond with an achievable configuration and validation approach.