Ratings and Reviews 858 Ratings
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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 C2P?
Compliance & Risks collaborates with leading global brands such as Dyson, Bose, EPSON and Samsung to streamline the ESG and Product Compliance process, facilitating smoother market entry.
Our offerings include three essential components:
1. An enterprise technology solution designed to enhance productivity and efficiency through our C2P platform, featuring the most extensive regulatory content available, encompassing over 40 topics across more than 20 industries and covering 195 nations globally.
2. Access to a dedicated team of experts ready to provide answers to any regulatory inquiries you might encounter.
3. Assistance in monitoring and evaluating the relevant regulations and standards pertinent to your products and business, ensuring you can demonstrate compliance to sustain and grow your market presence.
With over two decades of experience, we have established a stellar reputation for effectively aiding iconic brands in managing compliance risks, allowing them to thrive in competitive markets. Our commitment to supporting our clients positions us as a trusted partner in navigating the complexities of regulatory environments.
Integrations Supported
Asana
Auth0
Azure AI Anomaly Detector
Azure AI Document Intelligence
Azure DevOps Server
Azure-AD-External-Identities
Dynamics 365 Customer Service
Essenvia
GitHub
GitHub Advanced Security
Integrations Supported
Asana
Auth0
Azure AI Anomaly Detector
Azure AI Document Intelligence
Azure DevOps Server
Azure-AD-External-Identities
Dynamics 365 Customer Service
Essenvia
GitHub
GitHub Advanced Security
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
Compliance and Risks
Date Founded
2000
Company Location
Ireland
Company Website
www.complianceandrisks.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
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
Risk Management
Alerts/Notifications
Auditing
Business Process Control
Compliance Management
Corrective Actions (CAPA)
Dashboard
Exceptions Management
IT Risk Management
Internal Controls Management
Legal Risk Management
Mobile Access
Operational Risk Management
Predictive Analytics
Reputation Risk Management
Response Management
Risk Assessment