| Audit management | Supported | What configuration, module, licensing, integration or operating assumption is required for this capability in the target operating model? | QT9 Audit Management supports internal, external and supplier audits with scheduling, evidence, findings, CAPA and real-time reporting. |
| CAPA & corrective/preventive action management | Supported | What configuration, module, licensing, integration or operating assumption is required for this capability in the target operating model? | QT9 CAPA provides root-cause tools, corrective/preventive workflows, approvals, alerts, traceability and effectiveness follow-up. |
| Document control & change management | Supported | What configuration, module, licensing, integration or operating assumption is required for this capability in the target operating model? | QT9 includes document control, revision tracking, approvals and change-control modules in the integrated QMS. |
| Nonconformance, deviation & quality-event management | Supported | What configuration, module, licensing, integration or operating assumption is required for this capability in the target operating model? | QT9 includes Nonconforming Products, Quality Events and Deviation Management as integrated QMS modules. |
| Training & competency management | Supported | What configuration, module, licensing, integration or operating assumption is required for this capability in the target operating model? | QT9 includes employee training, assignments, skills tracking, tests and training records within the QMS. |
| Electronic signatures, audit trail & regulated records | Supported | What configuration, module, licensing, integration or operating assumption is required for this capability in the target operating model? | QT9 documents electronic-signature approvals, audit trail, IQ/OQ/PQ validation and 21 CFR Part 11 compliance controls. |
| ERP, MES, PLM & API integration | Supported | What configuration, module, licensing, integration or operating assumption is required for this capability in the target operating model? | QT9 documents ERP integration and a Quality Link ERP data connector for manufacturing quality workflows. |
| Inspection, SPC & shop-floor quality control | Partially Supported | What configuration, module, licensing, integration or operating assumption is required for this capability in the target operating model? | QT9 includes inspections, defect tracking, statistical reports and manufacturing quality dashboards, but dedicated SPC depth is not inferred beyond the reviewed evidence. |
| Quality analytics, KPIs & management review | Supported | What configuration, module, licensing, integration or operating assumption is required for this capability in the target operating model? | QT9 provides real-time reports, dashboards, charts, statistical reports and manufacturing quality KPIs. |
| Risk management & FMEA | Supported | What configuration, module, licensing, integration or operating assumption is required for this capability in the target operating model? | QT9 includes both Risk Management and FMEA modules as standard integrated QMS tools. |
| Supplier quality & SCAR management | Supported | What configuration, module, licensing, integration or operating assumption is required for this capability in the target operating model? | QT9 includes supplier evaluations, supplier surveys, supplier portal, supplier audits and supplier corrective-action workflows. |