| Audit management | Supported | What configuration, module, licensing, integration or operating assumption is required for this capability in the target operating model? | Ideagen includes audit management with automated evidence, checklists, findings and linked corrective action. |
| CAPA & corrective/preventive action management | Supported | What configuration, module, licensing, integration or operating assumption is required for this capability in the target operating model? | Ideagen documents automated CAPA workflows with root-cause analysis, corrective actions and effectiveness monitoring. |
| Document control & change management | Supported | What configuration, module, licensing, integration or operating assumption is required for this capability in the target operating model? | Ideagen Quality Management connects controlled documents, revisions, approvals and change-management workflows in one 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? | Ideagen connects nonconformance reporting to CAPA and other quality workflows for closed-loop quality management. |
| Training & competency management | Supported | What configuration, module, licensing, integration or operating assumption is required for this capability in the target operating model? | Ideagen training management tracks training records, competency, certifications and automated retraining triggers linked to quality workflows. |
| Electronic signatures, audit trail & regulated records | Partially Supported | What configuration, module, licensing, integration or operating assumption is required for this capability in the target operating model? | Ideagen documents support for standards including 21 CFR Part 11 and audit-ready controlled records; exact electronic-signature/validation scope should be confirmed for the selected solution. |
| ERP, MES, PLM & API integration | Supported | What configuration, module, licensing, integration or operating assumption is required for this capability in the target operating model? | Ideagen documents ERP and enterprise-tool integration plus API support for connected quality and training data. |
| Inspection, SPC & shop-floor quality control | Supported | What configuration, module, licensing, integration or operating assumption is required for this capability in the target operating model? | Ideagen documents inspection management plus supplier-quality scorecards using statistical process control; exact SPC depth should be validated for the selected configuration. |
| Quality analytics, KPIs & management review | Supported | What configuration, module, licensing, integration or operating assumption is required for this capability in the target operating model? | Ideagen provides cross-process quality visibility including audit performance, CAPA effectiveness, inspection trends and supplier quality. |
| Risk management & FMEA | Partially Supported | What configuration, module, licensing, integration or operating assumption is required for this capability in the target operating model? | Ideagen documents risk management throughout the connected QMS, but FMEA-specific scope is not inferred from the reviewed current pages. |
| Supplier quality & SCAR management | Supported | What configuration, module, licensing, integration or operating assumption is required for this capability in the target operating model? | Ideagen supplier quality covers qualification, scorecards, nonconformance, CAPA, audits, supplier communication and risk. |