SmartQMS: AI-Powered Quality Management & Compliance
SmartQMS 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.
SmartQMS Compliance Engine
ISO · FDA · GMP · Audit-Ready
How SmartQMS Works
Configure Standards
Select your regulatory standards (FDA, ISO, GMP)
Centralize Documents
Migrate and organize quality documentation
Automate Workflows
AI handles approvals, CAPA, and change control
Monitor Compliance
Real-time dashboards and automated alerts
Audit Ready
Always-current documentation and audit trails
What SmartQMS Delivers.
Centralized version management with automated approvals and electronic signatures.
Pre-configured for FDA 21 CFR, ISO 13485, ISO 9001, and GMP standards.
50% faster resolution cycles with automated corrective action workflows.
80% reduction in audit preparation time with real-time documentation.
Proactive identification compliant with ISO 14971 and ICH Q9 guidelines.
See SmartQMS in Action
Manual Compliance Is Putting You at Risk.
Organizations operating under FDA, ISO, and GMP regulations face mounting compliance challenges with paper-based and manual quality management processes.
Core Capabilities.
SmartQMS combines AI-powered automation with comprehensive quality management to keep your organization compliant and audit-ready.
Document Control & Management
Centralized document repository with version control, automated workflows, and electronic signatures. Compliant 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.
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 compliant with ISO 14971 and ICH Q9.
Training Management
Track employee training requirements, certifications, and competency assessments with automated reminders and compliance reporting.
SmartQMS Use Cases.
Medical Devices
Achieve FDA 21 CFR & ISO 13485 compliance with automated device design controls, production quality tracking, and post-market surveillance workflows.
Pharmaceuticals
Streamline GMP/cGMP compliance with automated batch record management, drug manufacturing quality controls, and regulatory submission support.
Biotech & Life Sciences
Manage R&D compliance workflows, clinical trial quality, lab documentation control, and IP protection processes with intelligent automation.
Contract Manufacturing
Centralize multi-standard compliance, supplier quality management, and cross-facility oversight for diverse client quality requirements.
Laboratory Management
Maintain ISO 17025 compliance with automated equipment calibration tracking, test method validation, and sample management.
Food & Beverage
Implement HACCP, achieve FDA FSMA compliance, and manage food safety quality controls with full traceability across your supply chain.
One Platform. Seven Intelligent Products.
Enterprise Security
Built for Enterprise Trust
and Compliance.
21 CFR Part 11 Compliance
Electronic signatures, audit trails, and access controls meeting FDA requirements for electronic records.
Role-Based Access Control
Granular permissions ensure quality documents and processes are only accessible to authorized personnel.
End-to-End Encryption
All quality data encrypted in transit (TLS 1.3) and at rest (AES-256). Complete data protection.
Complete Audit Trail
Every action, change, and approval is logged automatically. Always ready for regulatory inspections.
Data Integrity
Built to meet ALCOA+ principles for data integrity across all quality management processes.
Flexible Deployment
Cloud
Azure, AWS, or GCP. Fully managed, always current.
Private Cloud
Your cloud tenant. Your data boundary.
On-Premises
Full deployment inside your own infrastructure.
Air-Gapped
Isolated environments with no external connectivity.
Frequently Asked Questions.
SmartQMS Compliance is an AI-powered quality management and regulatory compliance platform. It serves medical device manufacturing, pharmaceutical, biotech, contract manufacturing, laboratory management, and food & beverage industries - anywhere quality and regulatory compliance are critical.
SmartQMS is pre-configured for FDA 21 CFR Part 11 & Part 820, ISO 13485:2016, ISO 9001:2015, ISO 14971, EU MDR & IVDR, Health Canada MDSAP, ISO 17025 for labs, and GMP/cGMP compliance. It covers the full spectrum of quality and regulatory requirements.
SmartQMS provides centralized document management with automated version control, electronic signatures compliant with 21 CFR Part 11, document approval workflows, change control management, distribution tracking, and retention/archival management.
CAPA (Corrective and Preventive Actions) management tracks and resolves quality issues. SmartQMS automates the entire CAPA lifecycle with root cause analysis tools, automated workflows, effectiveness verification, and trend tracking - reducing resolution cycles by up to 50%.
Yes. SmartQMS reduces audit preparation time by up to 80% with automated scheduling, finding management, comprehensive reporting, and always-current compliance documentation. All audit trails are maintained automatically for regulatory inspections.
SmartQMS provides proactive risk identification, assessment, and mitigation with automated workflows compliant with ISO 14971 and ICH Q9. It includes risk scoring, trend analysis, and automated alerts to prevent quality issues before they occur.
SmartQMS delivers real-time compliance dashboards, KPI tracking, trend analysis, custom report generation, regulatory reporting, and executive summary views - giving you complete visibility into quality metrics across your organization.
Request a demo to see SmartQMS in action for your specific quality management needs. Our team will assess your regulatory requirements, current processes, and help you plan a deployment tailored to your compliance standards.
Achieve 100% Compliance with AI-Powered QMS.
See how SmartQMS delivers automated quality management and regulatory compliance for your industry.
Request Demo