Intelligent eQMS with Closed-Loop Traceability, Compliance Automation, and Predictive Quality Analytics
Synesis AI eQMS is a modern, intelligent electronic quality management system purpose-built for manufacturers. With 14 integrated modules, AI-driven analytics, and complete audit trails, it brings closed-loop quality, compliance automation, and operational excellence together in one platform. From document control and CAPA to supplier scorecards and risk management, every record is linked, every action is traceable, and AI helps you catch quality issues before they become problems.
Built on Microsoft 365 and powered by artificial intelligence, Synesis AI eQMS leverages SharePoint, Teams, Power Automate, and AI services to deliver intelligent workflow automation, predictive quality insights, and a familiar user experience. Whether you're managing ISO 9001, IATF 16949, AS9100, FDA compliance, or other regulated standards, the system provides the workflows, audit trails, and AI-powered reporting your quality organization needs.
Predictive Analytics
AI-powered root cause analysis, predictive quality trends, intelligent event classification, and automated risk scoring. The system learns from your quality data to identify patterns, predict issues, and recommend preventive actions before problems reach the customer.
ISO-Compliant Workflow
Full document lifecycle with revision control, review and approval workflows, published document library, and read-and-understand acknowledgment tracking. AI assists with document classification, review routing, and compliance gap detection. Built on SharePoint for native Microsoft 365 integration.
AI-Assisted Root Cause
Six-step workflow from initiation through effectiveness check. AI-assisted root cause analysis using 5-Why, Fishbone, and Fault Tree methods. Action plan tracking, implementation monitoring, and AI-powered verification of corrective effectiveness across related quality records.
Intelligent NC Tracking
Track product, process, material, and documentation nonconformances. AI classifies severity, recommends containment actions, suggests disposition (rework, scrap, use-as-is, concession), and automatically escalates patterns to CAPA. Complete traceability from discovery to closure.
Internal & Supplier
Plan and execute internal audits, supplier audits, process audits, system audits, and regulatory audits. AI-powered checklist generation, finding documentation, severity assessment, and automatic escalation of critical findings to CAPA. Predictive audit readiness scoring.
Competency Tracking
Training matrix by role, department, and document. Auto-assignment when documents change. Completion tracking, scoring, retraining requirements, and evidence storage. AI identifies training gaps and recommends proactive retraining before audits.
Impact & Approval
Manage process, product, and system changes through formal review and approval. AI-assisted impact and risk assessment, cross-functional review coordination, implementation task tracking, and linked document and training updates powered by Power Automate workflows.
SCARs & Scorecards
Supplier master, qualification and requalification, approved supplier list, AI-generated performance scorecards, and SCAR tracking. Predictive supplier risk scoring identifies supply chain quality issues before they impact production.
AI Risk Scoring
Severity, occurrence, and detection scoring with automatic RPN calculation. AI-enhanced risk heatmaps, predictive mitigation recommendations, and linked controls. Machine learning identifies emerging risks from quality data patterns across your operations.
Unified Intake
Centralized quality event management for customer complaints, deviations, incidents, and observations. AI-powered triage, investigation assistance, root cause suggestion, and automatic escalation to nonconformance and CAPA. Never lose a quality signal.
Product Conformity
Receiving, in-process, and final inspection templates with pass/fail and measured value support. Instrument calibration tracking with due dates, certificates, and out-of-tolerance handling. AI auto-calculates results and flags statistical anomalies across inspection data.
SharePoint & Teams
Built on Microsoft SharePoint and fully integrated with Teams, Power BI, Power Automate, and Microsoft AI services. Familiar interface, enterprise-grade security with MFA and RBAC, mobile support via Power Apps, and electronic signatures for regulated environments.
Every audit finding automatically escalates to CAPA. AI assigns root causes, tracks action plans, and verifies effectiveness.
Customer complaints are logged, investigated, and linked to nonconformances and CAPA. AI tracks response patterns and prevents recurrence.
Significant nonconformances automatically create CAPA records. AI guides you from discovery through permanent corrective action.
Process changes flow to affected documents and training courses. Employees are automatically trained on changes before new instructions take effect.
Quality Management Systems. Document control, version history, CAPA, and management review audit trails.
Medical device quality system regulation. Electronic signatures, controlled document distribution, and change history.
Automotive quality management. APQP, PPAP, and supplier quality management processes with full traceability.
Medical devices. Risk management, design controls, and complaint handling with validated electronic workflows.
Full visibility into all quality activities, AI-powered executive dashboards, compliance reporting, and strategic KPIs.
Create and execute inspections, manage nonconformances, drive CAPA with AI-assisted root cause analysis.
Plan audits, execute checklists, document findings, and track escalation to CAPA with predictive readiness scoring.
Manage document libraries on SharePoint, coordinate reviews and approvals, enforce workflows, and publish effective documents.
Assign training, track completion, manage retraining, and report competency status with AI gap analysis.
Qualify suppliers, track performance with AI scorecards, manage SCARs, and maintain approved lists.
Report nonconformances, log quality issues from mobile devices, and monitor team training status via Teams.
AI-powered dashboards, predictive quality KPIs, management review reports, and strategic compliance insights.
Predictive analytics, automated root cause analysis, intelligent event classification, and proactive quality recommendations that get smarter over time.
SharePoint, Teams, Power Automate, Power BI, and Copilot. Familiar interface, enterprise security, and seamless integration with tools your team already uses.
Designed by people who understand manufacturing operations, compliance requirements, and continuous improvement. Not a generic template tool.
Every KPI, metric, and report drills down to underlying transactions. Audit findings trace to CAPA. Complaints trace to nonconformances. Complete traceability.
Every change logged with user, timestamp, and reason. Electronic signatures, document version history, and workflow audit trails. Always audit-ready.
Implementation support, quality process consulting, training, and ongoing optimization. 30 years of manufacturing IT expertise behind every deployment.
See how Synesis AI eQMS brings intelligent compliance, closed-loop traceability, and operational excellence together.
Contact Us About AI eQMS