Qualio Reviews & Ratings

Qualio

4.4 out of 5 stars
Company Website for Qualio

Ratings and Reviews 919 Ratings

Ratings and Reviews 0 Ratings

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ease 0 out of 5 stars
features 0 out of 5 stars
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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 QUMAS EQMS?

To accelerate the launch of new products while ensuring compliance with international standards, businesses need to optimize and automate their processes for collecting, monitoring, analyzing data, and tackling associated issues. QUMAS EQMS, formerly known as ProcessCompliance, is a cloud-based solution crafted for Enterprise Quality and Process Management, providing comprehensive integrated tools for managing regulatory, quality, and compliance aspects within a validated Quality Management System (QMS) framework. Utilizing QUMAS’s data-driven approach, organizations can proficiently handle quality-related information and easily access valuable quality data, which guarantees a clear view into their quality environment. In addition, QUMAS offers interactive quality dashboards that summarize QMS performance across different business sectors and quality initiatives, enabling users to visualize progress effectively. The platform allows for the generation of reports that can be exported, shared through email, or scheduled for regular updates, making it a versatile tool for communication. Moreover, it supports secure, efficient, and compliant information sharing among departments involved in QMS, thus fostering collaboration and improving operational efficiency. Ultimately, QUMAS equips organizations to achieve their quality goals while adeptly managing the intricacies of regulatory compliance, positioning them for success in a competitive landscape.

Media

Media

Integrations Supported

Asana
Auth0
Azure AI Document Intelligence
Azure DevOps
Azure DevOps Server
Azure-AD-External-Identities
Dynamics 365 Customer Service
Essenvia
GitHub
GitHub Advanced Security
GitHub Desktop
GitLab
GitLab Duo
Jira
Okta
RegDesk
SSOJet
Salesforce
Zephyr

Integrations Supported

AssurX

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

Pricing not provided

Supported Platforms

SaaS

Supported Platforms

SaaS

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training

Training Options

Documentation Hub
Webinars
On-Site Training

Company Facts

Organization Name

Qualio

Date Founded

2010

Company Location

United States

Company Website

www.qualio.com

Company Facts

Organization Name

Dassault Systemes

Date Founded

1981

Company Location

France

Company Website

www.3ds.com/products-services/biovia/products/life-sciences-quality-and-compliance/qumas-eqms/

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

Categories and Features

Quality Management

Compliance Management
Corrective and Preventive Actions (CAPA)
Training Management

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