Average Ratings 0 Ratings
Average Ratings 919 Ratings
Description
Numerous organizations globally rely on IQVIA to accelerate the drug development process, guarantee the safety and quality of products, enhance commercial efficacy, deliver appropriate treatments to patients, and ultimately promote improved health outcomes by facilitating access to and delivery of healthcare. Transform your approach to clinical development by seamlessly integrating data, technology, and analytics to streamline your trials. The outcome? Quicker decision-making and minimized risks, enabling you to provide transformative therapies at a faster pace. With its expertise rooted in data, sophisticated analytics, and deep industry knowledge, IQVIA offers tailored capabilities to clients throughout the healthcare landscape. Stay informed by exploring the latest insights and updates from IQVIA's data scientists, healthcare professionals, researchers, and other industry experts on crucial topics that resonate with your interests. From emerging industry developments to practical applications of our capabilities, a wealth of information awaits you here. Engaging with this content also empowers you to stay ahead in a rapidly evolving healthcare environment.
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.
API Access
Has API
No
API Access
Has API
No
Integrations
Azure AI Anomaly Detector
No
Azure AI Document Intelligence
No
Azure DevOps Labs
No
Azure DevOps Server
No
Dynamics 365 Customer Service
No
GitHub Desktop
No
GitLab
No
GitLab Duo
No
Google Cloud Operations Suite
No
Microsoft 365
No
Integrations
Azure AI Anomaly Detector
Yes
Azure AI Document Intelligence
Yes
Azure DevOps Labs
Yes
Azure DevOps Server
Yes
Dynamics 365 Customer Service
Yes
GitHub Desktop
Yes
GitLab
Yes
GitLab Duo
Yes
Google Cloud Operations Suite
Yes
Microsoft 365
Yes
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Pricing Details
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.
Free Trial
No
Free Version
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
Customer Support
Business Hours
Yes
Live Rep (24/7)
No
Online Support
Yes
Customer Support
Business Hours
Yes
Live Rep (24/7)
Yes
Online Support
Yes
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
No
In Person
No
Types of Training
Training Docs
Yes
Webinars
Yes
Live Training (Online)
Yes
In Person
No
Vendor Details
Company Name
IQVIA
Founded
1982
Country
United States
Website
www.iqvia.com
Vendor Details
Company Name
Qualio
Founded
2010
Country
United States
Website
www.qualio.com
Product Features
Clinical Trial Management
21 CFR Part 11 Compliance
No
Document Management
No
Electronic Data Capture
No
Enrollment Management
No
HIPAA Compliant
No
Monitoring
No
Patient Database
No
Recruiting Management
No
Scheduling
No
Study Planning
No
Healthcare CRM
Audience Targeting
No
Campaign Management
No
Marketing Automation
No
Medical History Records
No
Patient Communications
No
Patient Management
No
Physician Management
No
Predictive Analytics
No
Patient Engagement
Appointment Scheduling
No
Care Planning
No
Collaboration
No
Messaging
No
Mobile Access
No
Patient Education
No
Patient Portal
No
Personal Health Record
No
Progress Tracking
No
Self Management
No
Product Features
Compliance
Archiving & Retention
Yes
Artificial Intelligence (AI)
Yes
Audit Management
Yes
Compliance Tracking
Yes
Controls Testing
Yes
Environmental Compliance
Yes
FDA Compliance
Yes
HIPAA Compliance
Yes
ISO Compliance
Yes
Incident Management
Yes
OSHA Compliance
No
Risk Management
Yes
Sarbanes-Oxley Compliance
No
Surveys & Feedback
No
Version Control
Yes
Workflow / Process Automation
Yes
Policy Management
Approval Process Control
Yes
Attestation
Yes
Audit Trails
Yes
Policy Creation
Yes
Policy Library
Yes
Policy Metadata Management
Yes
Policy Training
Yes
Reporting / Analytics
Yes
Version Control
Yes
Workflow Management
Yes
Quality Management
Audit Management
Yes
Complaint Management
Yes
Compliance Management
Yes
Corrective and Preventive Actions (CAPA)
Yes
Defect Tracking
Yes
Document Control
Yes
Equipment Management
Yes
ISO Standards Management
Yes
Maintenance Management
Yes
Risk Management
Yes
Supplier Quality Control
Yes
Training Management
Yes