Pricing

Choose the TrackerQMS plan that fits your organization.

Start with Essentials, scale with Business Pro, and move to Enterprise for advanced supplier management, identity controls, integrations, and high-volume regulated operations.

Free Trial

Full Essentials trial experience

$07-day free trial
3 suppliers1 licensed user1 siteunlimited training users
  • Document Control
  • Training
  • CAPA
  • NCR
  • Audits & Findings
  • Basic Change Control
  • Supplier Management
  • Basic Risk Management
  • Standard Workflows
  • 21 CFR Part 11 Electronic Signatures
  • Audit Trails
  • Standard Dashboards & Reports
  • NO CREDIT CARD REQUIRED
Start Free Trial

Essentials

Core QMS for small teams

$2,495per month
50 suppliers10 licensed users1 siteunlimited training users
  • Document Control
  • Training
  • CAPA
  • NCR
  • Audits & Findings
  • Basic Change Control
  • Supplier Management
  • Basic Risk Management
  • Standard Workflows
  • 21 CFR Part 11 Electronic Signatures
  • Audit Trails
  • Standard Dashboards & Reports
Choose Essentials
Most Popular

Business Pro

Advanced QMS

$9,995per month
250 suppliers50 licensed users5 sitesunlimited training users
  • Everything in Essentials, plus...
  • Complaints
  • Field Actions
  • Equipment & Calibration
  • Out-of-Tolerance Events
  • Quality Events
  • Advanced Change Control
  • Advanced Supplier Quality
  • Qualifications & Competency
  • Training Effectiveness
  • Advanced Risk Management
  • Advanced Workflows & Routing
  • Workflow Automation
  • Cross-Module Relationships
  • Advanced Dashboards & Reports
  • API & Webhooks
  • Standard Integrations
Choose Business Pro

Enterprise

Complete enterprise QMS

$14,995per monthbilled annually at $179,940/year
500 suppliers
100 licensed users
unlimited sitesunlimited training users
  • Everything in Business Pro, plus...
  • SSO & SCIM
  • Enterprise Role Administration
  • Multi-Site Governance
  • Global & Site-Specific Permissions
  • Advanced API Access
  • ERP Integrations
  • Advanced Automation
  • Advanced AI Controls
  • Enterprise Audit & Traceability
  • Custom Retention Policies
  • Custom Document Identifier Policies
  • Validation Environment
  • Enterprise SLA
  • Implementation Support
  • Dedicated Customer Success
  • ANNUALIZED BILLING BY INVOICE
Choose Enterprise
AI Credits add-on

Add AI when you need it

Extend TrackerQMS with AI-powered assistance for analysis, drafting, summarization, and record creation. AI Credits are available as a usage-based add-on for eligible paid plans, giving you the flexibility to choose a monthly allowance and add more credits anytime.

Your AI Credit balance is shared across your TrackerQMS account, and unused purchased credits remain available while your account is active.

Monthly AI Credits

$49.95minimum per month
5,000+ AI Credits / month
Add AI credits in 1,000-credit increments at $9.99 per 1,000 credits, with a 5 block (5,000 credits) monthly minimum.

Choose the monthly allocation that fits your organization’s usage. Purchased credits roll forward, so you can build a balance during lighter months and use it when demand increases.

Additional AI Credits

$119.95one-time
10,000 AI Credits

Need more capacity? Add 10,000 AI Credits to your account at any time. Purchase as many top-up packs as needed to support periods of heavier AI usage. Purchased credits do not expire while your TrackerQMS account remains active.

AI Credits make AI features easy to manage.Your team uses AI Credits whenever they use AI-powered features across TrackerQMS. Add credits as needed and track usage from your account. AI add-ons are available with eligible paid plans and are not included with the Free Trial.
Plan comparison

See what is included in each plan.

Compare the capabilities included with each plan and choose the level that fits your current requirements.

CapabilityFree TrialEssentialsBusiness ProEnterprise
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
FAQ

Pricing questions

Can I start TrackerQMS with a free trial?

Yes. The free trial is intended to let regulated manufacturing teams evaluate core TrackerQMS workflows before selecting a paid plan.

Which plan is best for larger supplier networks?

Enterprise is designed for larger supplier volumes, broader user counts, integrations, identity controls, and multi-site quality programs.

How much does TrackerQMS AI cost?

AI is an optional paid add-on for eligible paid TrackerQMS subscriptions. Monthly AI Credits starts at $49.95 per month for 5,000 credits, billed in 1,000-credit blocks at $9.99 per block, Additional AI Credits is $119.95 one-time for 10,000 AI Credits.

Are AI Credits the same as model tokens?

No. TrackerQMS uses simple AI Credits so your team can use AI features without having to track or understand underlying model-token pricing.

Need help sizing Enterprise?

Tell us about your users, suppliers, sites, and requirements.

We will help you determine the appropriate Enterprise configuration.

Contact sales