21 CFR Part 11 e-signatures
Approvals re-ask the password, record the meaning and bind a hash of the signed content.
RBQMRisk-based quality management
Risk-based quality management in line with ICH E6(R3).
Galax RBQM follows the quality risk management cycle of ICH E6(R3) and E8(R1): identify what is critical to quality, assess the risks, control them with indicators, limits and monitoring, review the data centrally, act on signals and report the outcome. It works on the subjects, visits and CRF data of Galax EDC.
- E6(R3)
- Quality risk management cycle
- KRI + QTL
- Indicators and tolerance limits
- Targeted
- SDV and SDR strategy
Capabilities
Risk-based quality management in line with ICH E6(R3).
6 capability areas, all running under the same role-based access, electronic signatures and audit trail.
- 01
Risk assessment
Start from what is critical to quality.
- Risk register (RACT) with a standard risk library
- Critical-to-quality factors, critical data items and critical processes
- Control coverage of critical data and processes
- Approval and periodic review of the risk assessment
- 02
Indicators & limits
Measure risk with key risk indicators and quality tolerance limits.
- KRIs with thresholds and custom KRIs
- Drill-down by site comparison and trend
- QTLs with breach assessment
- Risk bands and monitoring strategy
- 03
Central monitoring & signals
Review data centrally and act on what it shows.
- Central statistical monitoring
- Control charts with run rules and funnel plots
- Signal triage, issues and actions
- Signed central monitoring review
- 04
Data integrity
Find patterns that a site-by-site review would miss.
- Subject-level anomalies and finding triage
- Possible duplicate patients
- Date and timing patterns
- Site data-quality score
- 05
Targeted SDV & SDR
Focus source verification where the risk is.
- Targeted SDV/SDR strategy with approved plan versions
- Subjects selected for SDV and CRA work list
- Source data review recording
- Adaptive triggers, proposals and site adjustments
- 06
Plan & oversight
One integrated, version-controlled quality plan.
- Integrated quality and risk management plan with change control
- Risk re-assessment triggers and version comparison
- Risk review meetings with agenda, decisions and approved minutes
- Site 360 risk profile, recommended actions and escalations
How it works
One accountable path from set-up to evidence.
Galax RBQM runs on the same users, roles, e-signatures and audit trail as the rest of the Galax platform.
- 01
Identify
Define critical-to-quality factors, data and processes.
- 02
Assess
Build and approve the risk register.
- 03
Control
Set KRIs, QTLs and the monitoring strategy.
- 04
Review
Run central monitoring and triage signals.
- 05
Act & report
Work issues, adjust SDV and record decisions.
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
- Central monitor
- CRA
- Data manager
- Clinical lead
- Quality assurance
Pricing
Licence fee.
Fees in USD, exclusive of taxes. Set-up and build fees are one-time and quoted separately.
Galax Site Monitoring / RBQM
One licence covers RBQM and Site Monitoring
$1,500per month
$18,000per year
Request a quoteBuild a quote →Rate card GLX/RATE/2026-27/003.
Contact
See Galax RBQM on your protocol.
Share your protocol synopsis, current workflow or delivery gap. We will respond with an achievable configuration and validation approach.