Qualio
4.4 out of 5 starsGreenlight Guru
4.4 out of 5 starsRatings and Reviews 919 Ratings
Ratings and Reviews 14 Ratings
What is Qualio?
Qualio is a unified quality and compliance platform that helps growing life sciences companies scale faster while staying continuously audit- and inspection-ready. Medical device, digital health, biotech, and pharma teams use Qualio to replace manual processes and disconnected tools with a single source of truth for quality, regulatory readiness, and risk.
With a modern eQMS at the foundation and Compliance Intelligence layered on top, Qualio moves teams beyond point-in-time audits. Automated gap analysis, cross-standard evidence mapping, and real-time readiness dashboards provide confidence that the organization is prepared today—not just when auditors arrive.
Qualio centralizes document control, training, CAPA, change management, supplier quality, and design controls, linking them directly to regulatory requirements and product lifecycle data. Executive-ready views show compliance health by standard, region, and product, turning regulatory readiness into a measurable business capability instead of a black box.
Compliance Intelligence continuously monitors for risk, highlights gaps early, and prioritizes remediation so teams focus effort where it matters most. Pre-validated regulatory frameworks are maintained as requirements evolve, reducing reliance on consultants and avoiding duplicate work as companies expand.
The result is faster market entry, lower compliance cost, reduced risk of findings or recalls, and confident, risk-managed growth.
What is Greenlight Guru?
Greenlight Guru serves more than 1,000 device manufacturers with a quality management system engineered specifically for medtech. Rather than forcing your workflow into a generic platform, the system is architected around regulatory reality. FDA 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, EU MDR, and 21 CFR Part 11 compliance is aligned at the core, not added as an afterthought.
Go live in weeks instead of quarters. You get 80+ pre-validated templates and medtech expert guidance, so you skip the separate validation project entirely.
Greenlight Guru integrates AI automation to reduce manual work while maintaining the audit trail and documentation rigor your business demands.
With 15 years specializing in medical device QMS, Greenlight Guru helps you pass inspections, accelerate time-to-market, and build lasting commercial success.
Integrations Supported
GitHub
Jira
Microsoft 365
Azure AI Anomaly Detector
Azure AI Document Intelligence
Azure DevOps Labs
Azure DevOps Server
ComplianceWire
Dynamics 365 Customer Service
Essenvia
API Availability
API Availability
Pricing Information
Qualio offers transparent, subscription-based pricing that scales with your users and needs. No hidden fees or per-module charges. Growth-stage companies benefit from fast time-to-value and significantly lower total cost of ownership than legacy platforms or consultant-heavy implementations. Contact us for a custom quote.n.
Pricing Information
Modules:
Document Management
Change Management
Training Management
Supplier Management
Design Controls
Risk Management
Parts Management
Quality Events
Software Parts
Software Release Management
SBOM Management
Software Test Automations
Pricing is custom scoped.
Document Management
Change Management
Training Management
Supplier Management
Design Controls
Risk Management
Parts Management
Quality Events
Software Parts
Software Release Management
SBOM Management
Software Test Automations
Pricing is custom scoped.
Supported Platforms
SaaS
Supported Platforms
SaaS
Customer Service / Support
Standard Support
24 Hour Support
Web-Based Support
Customer Service / Support
Standard Support
24 Hour Support
Web-Based Support
Training Options
Documentation Hub
Webinars
Online Training
Training Options
Documentation Hub
Webinars
Online Training
Company Facts
Organization Name
Qualio
Date Founded
2010
Company Location
United States
Company Website
www.qualio.com
Company Facts
Organization Name
Greenlight Guru
Date Founded
2013
Company Location
United States
Company Website
greenlight.guru
Categories and Features
Compliance
Archiving & Retention
Artificial Intelligence (AI)
Audit Management
Compliance Tracking
Controls Testing
Environmental Compliance
FDA Compliance
HIPAA Compliance
ISO Compliance
Incident Management
Risk Management
Version Control
Workflow / Process Automation
Electronic Batch Records (EBR)
Not specified
ISO Compliance
Not specified
Life Sciences
Not specified
Medical Quality Management Systems
Not specified
Pharmacovigilance
Not specified
Policy Management
Approval Process Control
Attestation
Audit Trails
Policy Creation
Policy Library
Policy Metadata Management
Policy Training
Reporting / Analytics
Version Control
Workflow Management
Product Compliance
Not specified
Quality Management
Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
ISO Standards Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management
Categories and Features
Electronic Batch Records (EBR)
Not specified
Medical Quality Management Systems
Not specified
Quality Management
Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Document Control
ISO Standards Management
Risk Management
Supplier Quality Control
Training Management