Ratings and Reviews 809 Ratings
Ratings and Reviews 0 Ratings
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 NiftyISO?
NiftyISO 9001 Audit software streamlines quality management by ensuring compliance, enhancing efficiency, and promoting uniformity across your organization. Accessible on multiple platforms such as the web, mobile devices, and tablets, it empowers users to improve quality from any setting, thus optimizing operations whether in the office or working from home. This adaptability helps teams to remain coordinated and dedicated to quality goals, ultimately resulting in improved performance and outcomes for the entire organization. With its user-friendly interface and comprehensive features, NiftyISO stands out as a vital tool for modern quality management.
Integrations Supported
Auth0
Azure AI Anomaly Detector
Azure AI Document Intelligence
Azure DevOps
Azure DevOps Server
Azure-AD-External-Identities
ComplianceWire
GitHub
GitHub Desktop
GitLab Duo
Integrations Supported
Auth0
Azure AI Anomaly Detector
Azure AI Document Intelligence
Azure DevOps
Azure DevOps Server
Azure-AD-External-Identities
ComplianceWire
GitHub
GitHub Desktop
GitLab Duo
API Availability
Has API
API Availability
Has API
Pricing Information
Pricing not provided.
Free Trial Offered?
Free Version
Pricing Information
$9 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
Niftysol
Date Founded
2012
Company Location
United States
Company Website
niftysol.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
Audit
Alerts / Notifications
Audit Planning
Compliance Management
Dashboard
Exceptions Management
Forms Management
Issue Management
Mobile Access
Multi-Year Planning
Risk Assessment
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