New: AI Compliance Intelligence — automate gap analysis across 30+ standards. Read the announcement
Now with AI-Powered Compliance Intelligence

Quality
Made Perfect

Quays is the quality management platform built for modern enterprises. Unite document control, compliance, training, and audit management on a single secure platform.

Platform Modules

10 modules.
One platform.

Every module works together seamlessly — data flows between them so you never duplicate work. Pick what you need today, add more as you grow.

Planning Processes Documents Audits Non Conformities Risks Suppliers Training BI Work Permit

Planning

Align quality objectives with business strategy. Define measurable goals, assign ownership, track progress with KPIs, and ensure continuous improvement across your organization.

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Processes

Design and control your quality processes with a visual workflow builder. Map process interactions, define SOPs, and monitor compliance with SLA tracking and performance analytics.

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Documents

Control every document from creation to retirement. Automated version control, multi-level approval workflows, electronic signatures, and intelligent distribution ensure the right people always have the right document.

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Audits

Manage your entire audit lifecycle — from annual planning and scheduling through execution, reporting, and finding closure. Ensure continuous audit readiness with structured checklists and automated follow-ups.

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Non Conformities

Capture, investigate, and resolve non-conformances with structured root-cause analysis. Link findings to CAPAs, track effectiveness, and prevent recurrence with a closed-loop corrective action system.

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Risks

Identify, assess, and mitigate risks with a structured framework. Maintain dynamic risk registers, visualize exposure with heat maps, and link risks to controls, actions, and audit findings.

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Suppliers

Evaluate, qualify, and continuously monitor your supply chain. Maintain an approved supplier list, conduct supplier audits, track performance with scorecards, and manage incoming quality inspections.

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Training

Ensure your team stays qualified and competent. Create training plans tied to roles, assign courses, track completions, and generate compliance reports with automated reminders and gap analysis.

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BI

Transform quality data into actionable insights. Create custom dashboards, generate compliance reports, analyze trends, and give leadership the visibility they need with board-ready executive summaries.

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Work Permit

Digitize your permit-to-work system for high-risk operations. Define hazard conditions, required approvals, safety checks, and monitoring protocols. Ensure no work starts without proper authorization.

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Q

Fully integrated, not bolted on

Unlike legacy QMS tools that duct-tape features together, every Quays module shares a single data model. A non-conformity links to a risk, which links to a document, which triggers training — automatically. No copy-paste. No data silos.

Single source of truth
Cross-module traceability
Automated workflows
Why Quays

Everything you need to
build, prove, and scale quality

One unified platform that replaces disconnected tools and spreadsheet chaos. Every module works together — compliance evidence, documents, audits, and training in a single data model.

Document Control

Manage SOPs, work instructions, and policies with automated versioning, approval workflows, and electronic signatures.

Training Management

Assign, track, and verify training completion. Ensure your team stays qualified with automated training plans and tracking.

Audit Management

Plan, execute, and close audits efficiently. Track findings, schedule follow-ups, and maintain continuous audit readiness.

CAPAs & Non-Conformances

Capture issues, investigate root causes, and implement corrective actions with full traceability and effectiveness checks.

Risk Management

Identify, assess, and mitigate risks with a structured framework. Maintain risk registers and link to controls and actions.

Change Control

Manage changes systematically with impact assessments, stakeholder approvals, and implementation tracking.

AI-Powered

Compliance Intelligence

Automate gap analysis across ISO 9001, ISO 13485, FDA 21 CFR Part 11, and 30+ other standards. Cross-map evidence once, reuse across submissions. Get real-time risk alerts and board-ready dashboards.

  • 80% reduction in audit prep time
  • 5x ROI in less than 2 months
  • 60% lower consultant spend
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Compliance Dashboard Live
ISO 9001:2015 94%
ISO 13485:2016 87%
FDA 21 CFR Part 11 91%
GxP Compliance 78%

Last scanned 2 minutes ago

How we compare

Why teams switch from legacy QMS to Quays

We don't lock you into per-module pricing, multi-year contracts or implementations measured in quarters.

Feature Quays MasterControl Greenlight Guru Qualio
Time to go-live 4 weeks 6–12 months 3–6 months 2–4 months
AI compliance gap analysis add-on
Cross-module data model partial partial
21 CFR Part 11 e-signatures
Per-module pricing No Yes Yes Yes
SOC 2 + ISO 27001 + GDPR + HIPAA partial partial
Native Power BI integration
Multi-company / multi-site
Dedicated implementation team Included $$$ $$ $$
Pricing

Start with a pilot. Scale when you’re ready.

Transparent per-user pricing. No hidden module fees. No multi-year lock-in.

Base

For growing teams running their first formal QMS.

$19 /user / month
Start free pilot
  • Up to 10 users
  • All 10 modules
  • Document control + e-sig
  • 8-hour support SLA

Enterprise

For regulated enterprises and global organizations.

$65 /user / month
Talk to sales
  • 120+ users
  • SAML SSO + SCIM
  • Dedicated CSM
  • 1-hour support SLA

No credit card required · 30-day free pilot · Cancel anytime

See full pricing
Platform deep dive
Document Control

Real-time compliance scanning — no manual checks required

Every document, SOP and record is continuously checked against ISO 9001, 13485, IATF 16949, FDA 21 CFR Part 11 and 25+ more standards. Issues flagged before they hit the audit floor.

  • AI gap analysis in < 30 seconds
  • Auto-generated audit evidence trail
  • Version history with e-signatures (21 CFR Part 11)
See document control
quays.io · document control
01
Access Control

Fine-grained permissions for any organization size

Organizations, sites, departments and roles. Robot accounts for system integrations. SAML SSO and IP allow-listing for the enterprise. Permissions that scale from a 10-person team to 50,000.

  • SAML SSO + SCIM provisioning
  • Role-based access control (RBAC) per module
  • Tamper-proof audit trails on every action
See access control
quays.io · access control
02
Automation

Automated workflows from your existing systems

Trigger reviews, approvals and CAPAs from Jira, GitHub Actions, ServiceNow, ERP events or your CI/CD. Your quality system reacts to your business in real time — no manual handoffs.

  • Native triggers for Jira, GitHub, GitLab, Bitbucket
  • Webhook & REST API for any system
  • Conditional logic & multi-step approval chains
See automation
quays.io · automation
03
Enterprise-Grade Security

Security and controls
you can trust

Quays meets the highest industry standards for security and compliance. We include all default controls that enterprise teams expect, so you can focus on quality, not infrastructure.

SAML SSO & SCIM provisioning
Role-based access controls
Complete audit trail logging
Data encryption at rest & in transit
IP allow-listing
Data lifecycle management
99.9% uptime SLA
Dedicated security team
More about security

SOC 2 Type II

Independently audited security controls

ISO 27001

Information security management

GDPR

Full EU data protection compliance

HIPAA

Healthcare data protection ready

Integrations

Connect with your
favorite tools

Quays connects with your existing ecosystem through APIs and native integrations. Feed your dashboards with quality data from platforms like Microsoft 365, Power BI, Google Suite, and Jira.

All integrations follow strict security standards, ensuring your data remains protected while flowing seamlessly between systems. Our team handles the integration setup so you can focus on what matters.

Learn about our integrations

Microsoft 365

Connect with Office apps, SharePoint, Teams, and more for seamless document and collaboration flows.

Power BI

Feed your dashboards and BI reports with real-time quality data directly from Quays.

Google Suite

Integrate with Google Workspace apps — Docs, Sheets, Drive, and Gmail — for complete workflow coverage.

Jira

Sync issues, tasks, and projects between Jira and Quays for unified project and quality tracking.

Services

More than software,
a full service

We provide consulting, training, and technical support for your quality management system, as well as platform integration with other systems.

Personalized Advisory

We offer specialized consulting to help you implement the platform and optimize your quality processes. Our team guides you through every step of the QMS journey.

Process Automation

We automate your quality processes to improve efficiency, reduce errors, and maximize your investment. From alert triggers to workflow orchestration.

Third-Party Integrations

We can integrate the platform with project management tools, service desks, or technical support and automatically feed your indicators from external data sources.

Why choose Quays

Get started with Quays quickly and accelerate the management of your processes, documents, and assessments. We design and develop custom-fit software.

Adaptability

We can customize the platform to your needs. We understand that every business has its own particularities, even when following the same standards.

Speed

It can take us as little as 4 hours to build a new report. Adaptations and the implementation process are completed in a short period of time.

Integration

We offer a service to integrate Quays with other applications within your organization, from a Power BI dashboard to a mobile application.

Frequently asked

Questions teams ask before switching

Is Quays free to try?

Yes. Every plan includes a 30-day free pilot with full platform access, unlimited users during the pilot, and white-glove onboarding from our team. No credit card required.

How does Quays compare to MasterControl, Greenlight Guru or Qualio?

Quays goes live in 4 weeks (vs 3–12 months), uses a single per-user price (no per-module fees), and ships AI compliance gap analysis natively across 30+ standards — not as a paid add-on.

Does Quays support FDA 21 CFR Part 11 e-signatures?

Yes. Every document, record and approval supports compliant electronic signatures with tamper-proof audit trails out of the box. Validated for FDA-regulated environments.

What is AI Compliance Intelligence?

Our AI continuously cross-maps your evidence against 30+ standards (ISO 9001, 13485, IATF 16949, FDA 21 CFR, ISO 27001, GDPR and more). It flags gaps in real time, generates audit-ready reports, and reduces consultant spend by ~60%.

Can I self-host Quays?

Enterprise customers can choose data residency in US, EU, LATAM or APAC regions. Fully on-premise or private-cloud deployments are available on request — contact sales.

Are there user or storage limits?

No artificial limits. Plans scale by user tier (10 → 25 → 120+), but every plan includes unlimited documents, audits, processes and integrations. No per-API-call billing.

How long does implementation take?

4 weeks on average for full validation, including data migration, SSO setup, custom workflows and training. Our dedicated implementation team is included on every plan.

Is my data secure?

SOC 2 Type II, ISO 27001, GDPR and HIPAA-ready. Encryption at rest (AES-256) and in transit (TLS 1.3), SAML SSO, IP allow-listing, role-based permissions and 99.99% uptime SLA on Enterprise.

Unlock world-class
quality management

Join 2,000+ organizations that trust Quays to manage quality, compliance, and continuous improvement. See how it works for your team.