| Administration |
| AI Assistant - UseUse AI assistant features. | ✓ | ✓ | ✓ | ✓ |
| API AccessUse external API access for integration scenarios. | — | — | — | ✓ |
| Automation - ManageManage workflows, approvals, business rules, notifications, and integrations. | — | — | ✓ | ✓ |
| Automation - ReadView workflows, approvals, business rules, notifications, and integrations. | — | — | ✓ | ✓ |
| Custom Fields - ManageManage customer-defined custom fields. | — | — | ✓ | ✓ |
| Groups - ManageCan manage user groups and group memberships | ✓ | ✓ | ✓ | ✓ |
| Integrations - ManageManage platform and business-system integrations. | — | — | — | ✓ |
| Integrations - ReadView integrations. | — | — | ✓ | ✓ |
| Permissions - ManageManage permissions, capabilities, and menu gates. | ✓ | ✓ | ✓ | ✓ |
| Roles - ManageManage application roles. | ✓ | ✓ | ✓ | ✓ |
| Sites - ManageSupport multiple site configuration. | ✓ | ✓ | ✓ | ✓ |
| Subscription - ManageManage subscription and billing settings. | ✓ | ✓ | ✓ | ✓ |
| System Logs - ReadView system logs and security events. | — | — | ✓ | ✓ |
| Use APIUse API features. | — | — | ✓ | ✓ |
| Users - ManageManage users and account access. | ✓ | ✓ | ✓ | ✓ |
| Webhooks - AccessConfigure outbound webhooks for system events. | — | — | ✓ | ✓ |
| Webhooks - ManageConfigure and manage webhook features. | — | — | — | ✓ |
| Alerts |
| Alert Rules - ManageCreate, update, enable, disable, and configure alert rules. | — | — | ✓ | ✓ |
| Alert Rules - ReadView alert rules and monitoring automation settings. | — | — | ✓ | ✓ |
| Alerts - ManageManage generated alerts, ownership, escalation state, and alert outcomes. | — | — | ✓ | ✓ |
| Alerts - ReadView generated customer alerts. | ✓ | ✓ | ✓ | ✓ |
| Audits |
| Audit - AdministrationManage audit programs, universe, templates, and settings. | — | — | ✓ | ✓ |
| Audit - ApprovalsApprove audit responses, findings, templates, and closure. | ✓ | ✓ | ✓ | ✓ |
| Audit - ArchiveArchive and restore audits. | — | — | ✓ | ✓ |
| Audit - CreateCreate new audits. | ✓ | ✓ | ✓ | ✓ |
| Audit - DashboardView audit dashboard and KPI data. | ✓ | ✓ | ✓ | ✓ |
| Audit - EvidenceManage audit evidence and binders. | — | — | ✓ | ✓ |
| Audit - ExecutePerform audit execution and answer checklist questions. | ✓ | ✓ | ✓ | ✓ |
| Audit - ExportExport audit records, findings, and binders. | — | — | ✓ | ✓ |
| Audit - FindingsManage audit findings. | ✓ | ✓ | ✓ | ✓ |
| Audit - ManagementAccess the audit management module. | ✓ | ✓ | ✓ | ✓ |
| Audit - ProgramsManage audit programs. | — | — | ✓ | ✓ |
| Audit - ReadRead audit records | ✓ | ✓ | ✓ | ✓ |
| Audit - SignaturesApply Part 11 signatures for audit workflows. | ✓ | ✓ | ✓ | ✓ |
| Audit - TeamManage auditor qualifications, audit team, and independence. | — | — | ✓ | ✓ |
| Audit - TemplatesManage audit templates and checklists. | — | — | ✓ | ✓ |
| Audit - UniverseManage audit universe and risk-based audit planning. | — | — | ✓ | ✓ |
| Audit - UpdateEdit audits before terminal lifecycle states. | ✓ | ✓ | ✓ | ✓ |
| Change Control |
| Change Control - ApproveApprove change control | — | — | ✓ | ✓ |
| Change Control - CreateCreate change control | — | — | ✓ | ✓ |
| Change Control - Manage SettingsManage change control settings | — | — | ✓ | ✓ |
| Change Control - ReadRead change control | — | — | ✓ | ✓ |
| Change Control - ReleaseRelease change control | — | — | ✓ | ✓ |
| Change Control - UpdateUpdate change control | — | — | ✓ | ✓ |
| Document Change OrdersCreate and process Document Change Orders. | ✓ | ✓ | ✓ | ✓ |
| Engineering Change OrdersCreate and process Engineering Change Orders. | — | — | ✓ | ✓ |
| Manufacturing Change OrdersCreate and process Manufacturing Change Orders. | — | — | ✓ | ✓ |
| Quality Change OrdersCreate and process Quality Change Orders. | — | — | ✓ | ✓ |
| Regulatory Change OrdersCreate and process Regulatory Change Orders. | — | — | ✓ | ✓ |
| Supplier Change OrdersCreate and process Supplier Change Orders. | — | — | ✓ | ✓ |
| Compliance |
| Compliance - ManageManage compliance frameworks, controls, evidence, assessments, and findings. | — | — | ✓ | ✓ |
| Compliance - ReadView compliance frameworks, readiness, controls, evidence, assessments, and findings. | ✓ | ✓ | ✓ | ✓ |
| Compliance Frameworks - ManageManage compliance frameworks and framework versions. | — | — | ✓ | ✓ |
| Validation PackageAccess validation support materials such as IQ/OQ templates and release evidence. | — | — | ✓ | ✓ |
| Document Control |
| Document Compliance - ManageManage document compliance controls and evidence. | — | — | ✓ | ✓ |
| Document Lifecycle - ManageManage lifecycle settings and records. | — | — | ✓ | ✓ |
| Document Lifecycle - ReadView lifecycle, review, retention, legal hold, and disposition records. | — | — | ✓ | ✓ |
| Document Lifecycle Jobs - ManageView and rerun lifecycle orchestration jobs. | — | — | ✓ | ✓ |
| Document Settings - ManageManage document identifiers, routing rules and retention policies | — | — | ✓ | ✓ |
| Document Templates - ManageConfigure document templates. | ✓ | ✓ | ✓ | ✓ |
| Document Types - ManageConfigure document types and document configuration. | ✓ | ✓ | ✓ | ✓ |
| Documents - ApproveApprove controlled documents. | ✓ | ✓ | ✓ | ✓ |
| Documents - ArchiveArchive or restore controlled documents. | ✓ | ✓ | ✓ | ✓ |
| Documents - CreateCreate or upload controlled documents. | ✓ | ✓ | ✓ | ✓ |
| Documents - DownloadDownload controlled documents | ✓ | ✓ | ✓ | ✓ |
| Documents - EditEdit controlled document metadata and versions. | ✓ | ✓ | ✓ | ✓ |
| Documents - ManageManage documents | ✓ | ✓ | ✓ | ✓ |
| Documents - ReadView controlled documents. | ✓ | ✓ | ✓ | ✓ |
| Documents - SignApply electronic signatures to controlled documents. | ✓ | ✓ | ✓ | ✓ |
| Engine |
| Part 11 - Basic SignaturesUse Part 11 basic electronic signature features. | ✓ | ✓ | ✓ | ✓ |
| Part 11 - Export EvidenceExport or print Part 11 evidence packages. | ✓ | ✓ | ✓ | ✓ |
| Part 11 - View EvidenceView auditor-facing signature evidence, hashes, snapshots, and audit context. | ✓ | ✓ | ✓ | ✓ |
| Workflows - AdvancedUse configurable approval chains, due dates, routing, and advanced workflow controls. | — | — | ✓ | ✓ |
| Workflows - ExecuteExecute workflow actions assigned to the user. | ✓ | ✓ | ✓ | ✓ |
| Workflows - ManageCreate and manage workflow definitions. | — | — | ✓ | ✓ |
| Workflows - Manage DelegationManage workflow delegation rules. | — | — | ✓ | ✓ |
| Workflows - ReadView workflow definitions and workflow activity. | ✓ | ✓ | ✓ | ✓ |
| Operations |
| Calibration - ManageCreate and manage calibration records. | — | — | ✓ | ✓ |
| Calibration - ReadView calibration records. | — | — | ✓ | ✓ |
| Equipment - AdministrationManage equipment settings, requirements, and controlled configuration. | — | — | ✓ | ✓ |
| Equipment - ApproveApprove calibration, maintenance, impact, and return-to-service decisions. | — | — | ✓ | ✓ |
| Equipment - CreateCreate equipment and measuring-device records. | — | — | ✓ | ✓ |
| Equipment - MaintainPerform and document preventive or corrective maintenance. | — | — | ✓ | ✓ |
| Equipment - ReleaseAuthorize equipment return to service and release of affected product or process. | — | — | ✓ | ✓ |
| Equipment - UpdateUpdate equipment master data and operational records. | — | — | ✓ | ✓ |
| Equipment - ViewView equipment, calibration, maintenance, and out-of-tolerance records. | — | — | ✓ | ✓ |
| Field Actions - AdministrationAdminister field-action configuration and controlled records. | — | — | ✓ | ✓ |
| Field Actions - ApproveApprove initiation, execution, and closure decisions for field actions. | — | — | ✓ | ✓ |
| Field Actions - CloseClose completed field actions after readiness and signature controls pass. | — | — | ✓ | ✓ |
| Field Actions - CreateCreate controlled field-action records. | — | — | ✓ | ✓ |
| Field Actions - UpdateUpdate field-action scope, affected items, and execution evidence. | — | — | ✓ | ✓ |
| Field Actions - ViewView recalls, corrections, removals, advisory notices, and field safety corrective actions. | — | — | ✓ | ✓ |
| Perform CalibrationPerform and document calibration activities. | — | — | ✓ | ✓ |
| Quality Events |
| CAPA - AdministrationAdminister CAPA settings. | — | — | ✓ | ✓ |
| CAPA - ApproveApprove CAPA workflow stages. | ✓ | ✓ | ✓ | ✓ |
| CAPA - CancelCancel CAPAs instead of permanently deleting them | ✓ | ✓ | ✓ | ✓ |
| CAPA - CloseClose CAPA records. | ✓ | ✓ | ✓ | ✓ |
| CAPA - CreateCreate CAPA records. | ✓ | ✓ | ✓ | ✓ |
| CAPA - Manage RoutingConfigure and manage CAPA routing rules and approvals. | — | — | ✓ | ✓ |
| CAPA - UpdateEdit CAPA records. | ✓ | ✓ | ✓ | ✓ |
| CAPA - Verify EffectivenessComplete and verify CAPA effectiveness checks. | ✓ | ✓ | ✓ | ✓ |
| CAPA - ViewView CAPA records and CAPA dashboards. | ✓ | ✓ | ✓ | ✓ |
| Complaints - CancelCancel complaint records. | — | — | ✓ | ✓ |
| Complaints - CloseClose Complaints | — | — | ✓ | ✓ |
| Complaints - CreateCreate Complaints | — | — | ✓ | ✓ |
| Complaints - ReadView complaint management records and dashboards. | — | — | ✓ | ✓ |
| Complaints - UpdateUpdate Complaints | — | — | ✓ | ✓ |
| Manage Quality Event RoutingConfigure CAPA, complaint, and nonconformance approval-routing rules. | — | — | ✓ | ✓ |
| Nonconformances - CancelCancel nonconformance records. | ✓ | ✓ | ✓ | ✓ |
| Nonconformances - CloseClose Nonconformances | ✓ | ✓ | ✓ | ✓ |
| Nonconformances - CreateCreate Nonconformances | ✓ | ✓ | ✓ | ✓ |
| Nonconformances - ReadView nonconformance records. | ✓ | ✓ | ✓ | ✓ |
| Nonconformances - UpdateUpdate Nonconformances | ✓ | ✓ | ✓ | ✓ |
| Reporting & Analytics |
| Analytics - ReadView TrackerQMS Analytics, QMS health, trends, and intelligence signals. | ✓ | ✓ | ✓ | ✓ |
| Analytics - ReadView analytics dashboards and compliance metrics. | ✓ | ✓ | ✓ | ✓ |
| Reports - ExportExport report data. | — | — | ✓ | ✓ |
| Reports - ReadView reports. | ✓ | ✓ | ✓ | ✓ |
| Sentinel AIUse AI Credits to enrich governed Sentinel intelligence signals. | — | — | ✓ | ✓ |
| Risk Management |
| Risk - AdminAdminister risk module configuration: scoring profiles, matrices, and approval rules. | ✓ | ✓ | ✓ | ✓ |
| Risk - ApproveApprove risk acceptance decisions and record Part 11 sign-offs. | ✓ | ✓ | ✓ | ✓ |
| Risk - ExportExport risk management records, registers, and reports. | ✓ | ✓ | ✓ | ✓ |
| Risk - ManageCreate and manage risk items, assessments, controls, and acceptance decisions. | ✓ | ✓ | ✓ | ✓ |
| Risk - Manage FilesCreate, edit, submit, release, review, and archive Risk Management Files. | ✓ | ✓ | ✓ | ✓ |
| Risk - Manage FMEACreate and maintain FMEA/FMECA sessions, items, actions, and residual evaluations. | — | — | ✓ | ✓ |
| Risk - Manage RegisterCreate, edit, assess, archive, and restore Risk Register records. | ✓ | ✓ | ✓ | ✓ |
| Risk - Manage Reviews and SignalsCreate, triage, correlate, review, and disposition risk signals and reviews. | — | — | ✓ | ✓ |
| Risk - Manage SettingsManage Risk registers, scoring profiles, acceptability matrices, and approval configuration. | — | — | ✓ | ✓ |
| Risk - ReadView risk registers, risk items, assessments, and controls. | ✓ | ✓ | ✓ | ✓ |
| Risk - Verify ControlsImplement controls and complete controlled verification and effectiveness records. | ✓ | ✓ | ✓ | ✓ |
| Risk - View ControlsView risk-control measures, implementation, verification, and effectiveness. | ✓ | ✓ | ✓ | ✓ |
| Risk - View DashboardAccess the Risk Management dashboard and enterprise risk posture. | ✓ | ✓ | ✓ | ✓ |
| Risk - View FilesView controlled Risk Management Files and lifecycle status. | ✓ | ✓ | ✓ | ✓ |
| Risk - View FMEAView FMEA/FMECA sessions, failure modes, effects, causes, controls, and RPN results. | — | — | ✓ | ✓ |
| Risk - View RegisterView Risk Register records and risk assessment results. | ✓ | ✓ | ✓ | ✓ |
| Risk - View Reviews and SignalsView periodic risk reviews and production/post-production signals. | — | — | ✓ | ✓ |
| Supplier Quality |
| Approved Supplier List - ViewView the approved supplier list. | ✓ | ✓ | ✓ | ✓ |
| Supplier Assessments - ApproveSupplier assessment approve capability. | — | — | ✓ | ✓ |
| Supplier Assessments - CreateSupplier assessment create capability. | — | — | ✓ | ✓ |
| Supplier Assessments - ManageCreate and manage supplier assessments. | — | — | ✓ | ✓ |
| Supplier Assessments - ViewView supplier assessments. | — | — | ✓ | ✓ |
| Supplier Audits - ManageManage supplier audit activity. | — | — | ✓ | ✓ |
| Supplier Compliance - ManageManage supplier compliance controls, evidence, remediation, and scoring. | — | — | ✓ | ✓ |
| Supplier Compliance - ViewView supplier compliance status and results. | ✓ | ✓ | ✓ | ✓ |
| Supplier Documents - ManageUpload, edit, approve, archive, and manage supplier documents. | ✓ | ✓ | ✓ | ✓ |
| Supplier Documents - ViewView supplier-controlled documents. | ✓ | ✓ | ✓ | ✓ |
| Supplier Scorecards - ApproveApprove supplier scorecards. | — | — | ✓ | ✓ |
| Supplier Scorecards - CreateCreate supplier scorecards. | — | — | ✓ | ✓ |
| Supplier Scorecards - ViewView supplier scorecards. | — | — | ✓ | ✓ |
| Supplier Settings - ManageManage supplier settings | — | — | ✓ | ✓ |
| Suppliers - ArchiveArchive suppliers instead of permanently deleting them | ✓ | ✓ | ✓ | ✓ |
| Suppliers - CreateCreate supplier records. | ✓ | ✓ | ✓ | ✓ |
| Suppliers - ExportExport supplier data. | — | — | ✓ | ✓ |
| Suppliers - ReadView supplier records and supplier details. | ✓ | ✓ | ✓ | ✓ |
| Suppliers - UpdateEdit supplier records. | ✓ | ✓ | ✓ | ✓ |
| System |
| System AdministrationAdminister system configuration, email, audit logs, background jobs, feature flags, SSO, SCIM, and API keys. | — | — | — | — |
| Training |
| Training - AdminAdminister training settings. | ✓ | ✓ | ✓ | ✓ |
| Training - Approval AdminConfigure Training course approval matrices and approval workflow rules. | ✓ | ✓ | ✓ | ✓ |
| Training - ApproveApprove waivers, effectiveness checks, and training exceptions. | ✓ | ✓ | ✓ | ✓ |
| Training - AssignAssign training to users, roles, departments, and groups. | ✓ | ✓ | ✓ | ✓ |
| Training - CompleteComplete assigned training and acknowledgements. | ✓ | ✓ | ✓ | ✓ |
| Training - Create CoursesCreate training courses | ✓ | ✓ | ✓ | ✓ |
| Training - Evidence AdminGenerate and review immutable Training evidence packages. | ✓ | ✓ | ✓ | ✓ |
| Training - Hardening AdminRun Training SLA, escalation, evidence, and compliance hardening automation. | ✓ | ✓ | ✓ | ✓ |
| Training - ManageManage training courses, curricula, requirements, quizzes, and matrix rules. | ✓ | ✓ | ✓ | ✓ |
| Training - ReadView training module, assignments, courses, and records. | ✓ | ✓ | ✓ | ✓ |
| Training - SignApply required Part 11 training signatures. | ✓ | ✓ | ✓ | ✓ |
| Training - Update CoursesCan update training courses | ✓ | ✓ | ✓ | ✓ |