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Ratings and Reviews 919 Ratings

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

Integrations Supported

Auth0
Azure AI Document Intelligence
Azure DevOps
Azure DevOps Labs
Azure-AD-External-Identities
ComplianceWire
Dynamics 365 Customer Service
Essenvia
GitHub
GitHub Advanced Security
GitHub Desktop
GitLab
GitLab Duo
Google Cloud Operations Suite
Jira
Microsoft 365
Okta
SSOJet
Salesforce
TestRail

API Availability

API Availability

Pricing Information

Pricing not provided
Free Trial Offered?

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.

Supported Platforms

SaaS

Supported Platforms

SaaS

Customer Service / Support

Standard Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Online Training

Training Options

Documentation Hub
Webinars
Online 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)
Document Control
ISO Standards Management
Risk 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
Risk Management
Version Control
Workflow / Process Automation

ISO Compliance

Not specified

Life Sciences

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

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