21 CFR Part 11 e-signatures
Approvals re-ask the password, record the meaning and bind a hash of the signed content.
RIMRegulatory information management
Products, registrations and health-authority work in one register.
Galax RIM keeps the regulatory picture of every product in one place. A product has registrations — marketing authorisations, clinical trial applications, INDs and licences — in many countries. Regulatory activities change those registrations, and country requirements, labelling, health-authority interactions, planning, periodic reporting, fees, manufacturing sites and product data surround that core.
- One
- Register of products and registrations
- CCDS
- To local label alignment
- IDMP
- Product data records
Capabilities
Products, registrations and health-authority work in one register.
8 capability areas, all running under the same role-based access, electronic signatures and audit trail.
- 01
Products & registrations
The core register.
- Product master and product page
- Registrations by country with their history
- 02
Regulatory activities
Every submission that changes a registration.
- Regulatory activities with sign-off, submission and decision
- Fees of an activity
- Rollout plans with baseline, timeline, dependencies and slippage
- 03
Health-authority interactions
Questions, meetings and commitments tracked to closure.
- Health-authority questions and correspondence log
- Commitments and obligations
- Meetings with briefing package, attendees, minutes and outcomes
- 04
Change control
Assess the regulatory impact of every change.
- Change control with impact assessment
- Approval and generated regulatory activities
- 05
Country requirements
A versioned library of what each country requires.
- Country requirements library with versions
- Prefill and renewal rule deviations
- 06
Labelling
Keep local labels aligned with the core data sheet.
- CCDS versions with approval
- Local labels and CCDS-to-local alignment tracker
- Label change requests
- 07
Periodic reporting & fees
Never miss a periodic report or fee.
- Periodic reporting calendar with reporting rules and the EURD list
- Workload by month
- Agency fees, budget against actual and exchange rates
- 08
Manufacturing & product data
Sites, GMP evidence and structured product data.
- Manufacturing sites with GMP certificates, inspections and licences
- Expiring evidence linked to registrations
- IDMP product data with completeness and xEVMPD-style export
How it works
One accountable path from set-up to evidence.
Galax RIM runs on the same users, roles, e-signatures and audit trail as the rest of the Galax platform.
- 01
Register
Set up products and registrations by country.
- 02
Plan
Plan activities, rollouts and periodic reports.
- 03
Submit
Sign off and submit; record the decision.
- 04
Respond
Answer questions and track commitments.
- 05
Maintain
Keep labels, sites and product data current.
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 affairs
- Regulatory operations
- Labelling
- Quality assurance
Contact
See Galax RIM on your protocol.
Share your protocol synopsis, current workflow or delivery gap. We will respond with an achievable configuration and validation approach.