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What is Qualios?

We have developed intuitive and efficient tools to optimize your EDM and document validation process. You can effectively monitor your workflow with user-friendly dashboards, tailored forms, and real-time analytics. With Qualios, you can manage your workflow seamlessly through two integrated tools that improve how you handle your information system. It's vital to ensure that your information remains up-to-date and easily trackable; our Qualios Doc solution gives you the capability to manage your documents and monitor their progress. Qualios Manager is adaptable to fit your unique quality indicators, enabling you to create clear and insightful forms and dashboards for quick oversight of your internal operations. The enhancement process requires vigilant monitoring of all your activities for optimal results. Qualios is specifically designed to bolster your quality assurance efforts and aid you in meeting ISO 9001, ISO 14001, or 18001 compliance standards. Furthermore, these improvement processes are intended to be straightforward and not overly complicated. By incorporating our solutions, you can shift your focus toward achieving your objectives rather than getting bogged down by administrative duties. Ultimately, this allows for a more streamlined approach to quality management and operational efficiency.

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.

Media

Media

Integrations Supported

Asana
Auth0
Azure AI Anomaly Detector
Azure AI Document Intelligence
Azure DevOps
Azure DevOps Labs
Azure DevOps Server
ComplianceWire
Dynamics 365 Customer Service
GitHub
GitHub Advanced Security
GitHub Desktop
GitLab
GitLab Duo
Google Cloud Operations Suite
Microsoft 365
Okta
Salesforce
TestRail
Zephyr

Integrations Supported

Asana
Auth0
Azure AI Anomaly Detector
Azure AI Document Intelligence
Azure DevOps
Azure DevOps Labs
Azure DevOps Server
ComplianceWire
Dynamics 365 Customer Service
GitHub
GitHub Advanced Security
GitHub Desktop
GitLab
GitLab Duo
Google Cloud Operations Suite
Microsoft 365
Okta
Salesforce
TestRail
Zephyr

API Availability

Has API

API Availability

Has API

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

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
On-Site Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

Qualios

Date Founded

2006

Company Location

France

Company Website

www.qualios.com

Company Facts

Organization Name

Qualio

Date Founded

2010

Company Location

United States

Company Website

www.qualio.com

Categories and Features

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

Compliance

Archiving & Retention
Artificial Intelligence (AI)
Audit Management
Compliance Tracking
Controls Testing
Environmental Compliance
FDA Compliance
HIPAA Compliance
ISO Compliance
Incident Management
OSHA Compliance
Risk Management
Sarbanes-Oxley Compliance
Surveys & Feedback
Version Control
Workflow / Process Automation

Policy Management

Approval Process Control
Attestation
Audit Trails
Policy Creation
Policy Library
Policy Metadata Management
Policy Training
Reporting / Analytics
Version Control
Workflow Management

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

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