Average Ratings 858 Ratings
Average Ratings 0 Ratings
Description
Qualio is a purpose-built quality and compliance platform for life sciences companies operating in complex, high-stakes regulatory environments. Medical device, SaMD, biotech, and pharma teams use Qualio to replace fragmented eQMS tools, spreadsheets, and consultant-driven audits with a single, validated system that delivers continuous audit and inspection readiness.
Qualio combines a modern eQMS with Compliance Intelligence—an AI-driven layer that continuously evaluates how well real operating data aligns with regulatory requirements. Instead of treating audits as one-off events, teams gain always-on visibility into compliance coverage, risk exposure, and readiness across FDA, ISO, EU MDR, GxP, and software-intensive standards.
Core quality workflows—document control, training, CAPA, change management, supplier quality, and design controls—are directly connected to regulatory obligations and objective evidence. Deep integrations with Jira, Azure DevOps, GitHub, TestRail, and Salesforce automatically capture proof from development and operational systems, eliminating manual evidence gathering and reducing compliance drag on engineering teams.
Compliance Intelligence runs multi-standard gap analysis in under an hour, flags emerging risks before they become findings or 483s, and maps reusable evidence across frameworks to accelerate submissions and market expansion. All insights are explainable and traceable back to specific clauses and internal policies, supporting validation and audit expectations.
The result: audit readiness in weeks instead of months, fewer fire drills, faster launches, and lower long-term compliance cost. Qualio turns compliance from a reactive burden into a predictable, scalable system.
Description
Maintaining product safety, overseeing regulatory adherence, and fostering responsible design and management of products throughout their entire lifecycle presents a significant challenge. This difficulty is compounded by increasing consumer vigilance and dwindling resources. By utilizing Verisk 3E™ as your reliable partner for global regulatory knowledge and compliance solutions, you can effectively anticipate and adjust to regulatory shifts, swiftly address evolving customer needs, prevent disruptions in the supply chain, and speed up your time to market. We offer an extensive and robust suite of intelligent compliance solutions tailored for product safety and stewardship. As R&D professionals face limited resources, ever-evolving regulatory demands, rapid-fire customer expectations, and fragmented information systems, they must adapt with unprecedented agility, all while ensuring the integrity and safety of their products. This heightened necessity for adaptability makes the role of R&D even more critical in today’s fast-paced market.
API Access
Has API
API Access
Has API
Integrations
Asana
Azure AI Anomaly Detector
Azure AI Document Intelligence
Azure DevOps Labs
Azure DevOps Server
Azure-AD-External-Identities
Dynamics 365 Customer Service
Essenvia
GitHub
GitHub Desktop
Integrations
Asana
Azure AI Anomaly Detector
Azure AI Document Intelligence
Azure DevOps Labs
Azure DevOps Server
Azure-AD-External-Identities
Dynamics 365 Customer Service
Essenvia
GitHub
GitHub Desktop
Pricing Details
No price information available.
Free Trial
Free Version
Pricing Details
No price information available.
Free Trial
Free Version
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Vendor Details
Company Name
Qualio
Founded
2010
Country
United States
Website
www.qualio.com
Vendor Details
Company Name
Verisk 3E
Founded
1988
Country
United States
Website
www.verisk3e.com
Product 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
Product Features
Chemical
Certificates of Analysis
Chemical Process Simulation
Computer-Assisted Structure Elucidation (CASE)
ISO Management
Inventory Management
Particle Tracking
Reporting & Statistics
Samples Tracking
Traceability
Uncertainty Analysis
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