QMS Compliance: AI-Powered Quality Management & Compliance Platform
QMS Compliance transforms quality management with intelligent automation, ensuring regulatory compliance across FDA, ISO, and industry standards. From document control to CAPA management, audit tracking to risk assessment streamline every aspect of quality operations with enterprise-grade reliability.
Core Capabilities
Comprehensive quality management and compliance automation
Document Control & Management
Centralized document repository with version control, automated workflows, and electronic signatures. Ensure compliance with 21 CFR Part 11 and ISO standards.
CAPA Management
Track and manage Corrective and Preventive Actions with automated workflows, root cause analysis tools, and effectiveness verification.
Compliance Monitoring
Real-time compliance tracking across FDA, ISO 13485, ISO 9001, and industry-specific regulations with automated alerts and risk assessments.
Audit Management
Plan, execute, and track internal and external audits with automated scheduling, finding management, and comprehensive reporting.
Risk Management
Proactive risk identification, assessment, and mitigation with automated workflows and compliance with ISO 14971 and ICH Q9.
Training Management
Track employee training requirements, certifications, and competency assessments with automated reminders and compliance reporting.
Comprehensive Feature Set
Everything you need for quality management and regulatory compliance
Document Management
- Automated version control
- Electronic signatures (21 CFR Part 11)
- Document approval workflows
- Change control management
- Document distribution tracking
- Retention and archival management
Quality Processes
- Non-conformance management
- Deviation tracking and investigation
- Complaint handling (ISO 10002)
- Supplier quality management
- Product lifecycle management
- Change control procedures
Compliance & Regulatory
- FDA 21 CFR compliance
- ISO 13485 / ISO 9001 support
- EU MDR / IVDR compliance
- MDSAP requirements
- Audit trail and logging
- Regulatory submission support
Analytics & Reporting
- Real-time compliance dashboards
- KPI tracking and metrics
- Trend analysis and insights
- Custom report generation
- Regulatory reporting
- Executive summary views
Industry Applications
Trusted by quality professionals across regulated industries
Medical Device Manufacturing
Ensure FDA and ISO 13485 compliance for medical device production
Pharmaceutical Quality
Maintain GMP compliance and manage drug manufacturing quality
Biotech & Life Sciences
Streamline R&D compliance and clinical trial quality management
Contract Manufacturing
Meet client quality requirements and regulatory standards
Laboratory Management
ISO 17025 compliance and quality control for testing labs
Food & Beverage Safety
HACCP, FDA FSMA, and food safety quality management
Regulatory Compliance Coverage
Pre-configured for major quality and regulatory standards
Measurable Business Impact
Transform quality operations with proven results
80% reduction in audit preparation time
100% compliance with regulatory requirements
50% faster CAPA resolution cycles
Real-time visibility into quality metrics
Automated compliance documentation
60% reduction in quality-related costs
Streamlined regulatory submissions
Enhanced supplier quality collaboration
Ready to Transform Your Quality Management?
Start your AI-powered compliance transformation with QMS Compliance today