A complete QMS in one workspace
ClinixQM brings together everything you need for quality management and regulatory compliance. No more scattered spreadsheets, disconnected tools, or manual evidence collection.
Version-controlled documents with approval workflows
Create, review, approve, and retire documents with full audit trail. Every change is tracked, every approval is recorded, and every version is preserved.
- Configurable approval workflows with parallel and sequential steps
- AI-assisted document writing with compliance-aware suggestions
- Template library with pre-built SOPs, work instructions, and forms
- Document linking and traceability across the system
Document lifecycle from draft to retirement
ISO 14971-aligned risk analysis
ISO 14971-aligned risk analysis
Systematic hazard identification, risk estimation, and control measures. Link risks to design inputs, verification activities, and post-market data.
- Hazard identification with cause and effect analysis
- Configurable severity/probability matrices
- Risk control measures with verification tracking
- Benefit-risk analysis and residual risk assessment
Structured corrective and preventive actions
From problem identification to effectiveness verification. Track root causes, assign actions, and close CAPAs with documented evidence.
- Root cause analysis tools (5 Whys, fishbone diagrams)
- Action assignment with due dates and reminders
- Effectiveness verification with evidence attachments
- Trending and metrics for quality review
CAPA workflow from issue to closure
Training records and compliance tracking
Training records that stay current
Assign training, track completion, and maintain audit-ready records. Automatic reminders for recertification and document-triggered retraining.
- Training module creation with quizzes and acknowledgments
- Automatic assignment when documents are updated
- Recertification scheduling with reminders
- Training matrix and gap analysis
And much more
Everything else you need for complete quality management.
Compliance Tracking
Map your QMS to UK MDR, EU MDR, FDA 21 CFR, ISO 13485, and other regulatory frameworks. Visual dashboards show compliance status at a glance.
Audit Management
Plan and track internal audits, supplier audits, and external audits. Record findings, assign CAPAs, and maintain audit history.
Supplier Management
Qualify suppliers, track performance, and manage supplier-related risks. Maintain approved supplier lists with qualification records.
Design Controls
Manage design inputs, outputs, verification, and validation. Build traceability matrices and maintain design history files.
Complaint Handling
Receive, investigate, and resolve customer complaints. Link to CAPAs, vigilance reports, and post-market surveillance.
Audit Packs
Generate evidence packages for auditors with selected documents, records, and traceability. Share via secure, time-limited links.
See ClinixQM in action
Start your free trial and explore all features with sample data.