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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 Qooling?

Qooling empowers organizations to enhance their safety, quality, and security through data-driven insights. With all the necessary tools centralized on a single platform, you can foster a stronger safety culture and elevate quality standards. Achieving continuous improvement relies on the collective contributions of everyone involved. The user-friendly tools facilitate employee engagement effortlessly. Each user's personal desktop is tailored dynamically according to their preferences, ensuring that only the most critical information is readily accessible. This innovative approach guarantees that all team members can maximize their productivity and effectiveness without overlooking any issues. Team members can conveniently report nonconformities by taking a quick photo with their smartphone, eliminating the hassle of outdated procedures and work instructions. Qooling expertly manages version control, ensuring that everyone operates with the latest documents. Additionally, the platform boasts a plethora of exciting features designed to streamline processes and enhance collaboration. Overall, Qooling is an invaluable resource for organizations committed to continuous improvement and operational excellence.

Media

Media

Integrations Supported

Okta
Asana
Auth0
Azure DevOps
Azure-AD-External-Identities
Dynamics 365 Customer Service
Essenvia
GitHub
GitHub Advanced Security
GitHub Desktop
GitLab
GitLab Duo
HubSpot CRM
Indent
Intercom
Microsoft OneDrive
Salesforce
TestRail
Xray
Zephyr

Integrations Supported

Okta
Asana
Auth0
Azure DevOps
Azure-AD-External-Identities
Dynamics 365 Customer Service
Essenvia
GitHub
GitHub Advanced Security
GitHub Desktop
GitLab
GitLab Duo
HubSpot CRM
Indent
Intercom
Microsoft OneDrive
Salesforce
TestRail
Xray
Zephyr

API Availability

Has API

API Availability

Has API

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Pricing Information

$12 per user per month
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

Qualio

Date Founded

2010

Company Location

United States

Company Website

www.qualio.com

Company Facts

Organization Name

Qooling

Date Founded

2015

Company Location

Netherlands

Company Website

www.qooling.com

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

Categories and Features

EHS Management

Audit Management
Corrective / Preventive Actions
Environmental Management
Environmental Risk Assessment
Forms Management
Incident Management
Industrial Safety Management
Injury Reporting
Inspection Management
MSDS
OSHA Recordkeeping
Occupational Health Management
Safety Risk Assessment
Training Management
Waste 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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