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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 AuditUtopia?

AuditUtopia is a trusted real-time inspection management platform utilized by life sciences companies globally to facilitate audits and inspections. With features like the ability to log inspection notes, utilize chatrooms, and receive real-time updates, it simplifies the inspection process significantly. Users can also make custom requests and generate detailed reports with ease. This system acts as the central hub for your inspection and audit hosting needs, enhancing efficiency and reducing response times to inquiries. By adopting AuditUtopia, organizations can expect a marked improvement in their overall audit management workflow.

Media

Media

Integrations Supported

Azure AI Anomaly Detector
Azure AI Document Intelligence
Azure DevOps Labs
Azure DevOps Server
Azure-AD-External-Identities
ComplianceWire
Dynamics 365 Customer Service
Essenvia
GitHub
GitHub Desktop
GitLab
GitLab Duo
Google Cloud Operations Suite
HubSpot CRM
Microsoft 365
Microsoft OneDrive
Okta
TestRail
Zendesk
Zephyr

Integrations Supported

Azure AI Anomaly Detector
Azure AI Document Intelligence
Azure DevOps Labs
Azure DevOps Server
Azure-AD-External-Identities
ComplianceWire
Dynamics 365 Customer Service
Essenvia
GitHub
GitHub Desktop
GitLab
GitLab Duo
Google Cloud Operations Suite
HubSpot CRM
Microsoft 365
Microsoft OneDrive
Okta
TestRail
Zendesk
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

Qualio

Date Founded

2010

Company Location

United States

Company Website

www.qualio.com

Company Facts

Organization Name

PSC Software

Date Founded

1996

Company Location

United States

Company Website

pscsoftware.com/software/auditutopia/

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

Audit

Alerts / Notifications
Audit Planning
Compliance Management
Dashboard
Exceptions Management
Forms Management
Issue Management
Mobile Access
Multi-Year Planning
Risk Assessment
Workflow Management

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