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Average Ratings 858 Ratings

Description

Natively built and operated on the Salesforce platform, QHSE is the fastest growing Enterprise Quality, Health and Safety Management System. Unified QHSE solutions combine EQMS with EHS to help customers of all sizes deliver high quality products and services in a safe and sustainable manner. They reduce risk, inefficiencies, and inefficiencies, while protecting their customers, employees, and brand.

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

API Access

Has API

Screenshots View All

Screenshots View All

Integrations

Salesforce
Azure AI Anomaly Detector
Azure AI Document Intelligence
Azure DevOps
Azure DevOps Labs
Azure DevOps Server
Azure-AD-External-Identities
Dynamics 365 Customer Service
GitHub Advanced Security
GitLab
HubSpot CRM
Intercom
Microsoft Dynamics 365
NetSuite
Okta
Puntt AI
RegDesk
SAP CRM
Salesforce Agentforce Service
Zephyr

Integrations

Salesforce
Azure AI Anomaly Detector
Azure AI Document Intelligence
Azure DevOps
Azure DevOps Labs
Azure DevOps Server
Azure-AD-External-Identities
Dynamics 365 Customer Service
GitHub Advanced Security
GitLab
HubSpot CRM
Intercom
Microsoft Dynamics 365
NetSuite
Okta
Puntt AI
RegDesk
SAP CRM
Salesforce Agentforce Service
Zephyr

Pricing Details

$30 per user per month
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

ComplianceQuest

Founded

2013

Country

United States

Website

www.compliancequest.com

Vendor Details

Company Name

Qualio

Founded

2010

Country

United States

Website

www.qualio.com

Product Features

Audit

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

CAPA

Audit Management
CAPA Planning
Change Management
Complaint Management
Incident Management
Nonconformance Tracking
Quality Control
Risk Management
Root Cause Analysis
Training Management

Change Management

Approval Workflow
Audit Trail
Automated Notifications
Change Calendar
Change Planning
Compliance Management
Prioritization
Release Management
Task Management
Tracking & Reporting
Training Management

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

Complaint Management

Case Management
Complaint Classification
Corrective Actions (CAPA)
Customer Complaint Tracking
Feedback Management
Forms Management
Issue Tracking
Quality Assurance Management
Routing
Self Service Portal
Social Media Monitoring
Survey Management

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

Document Control

Archiving & Retention
Automated Routing
Change Management
Compliance Management
Electronic Signature
Escalation Management
Periodic Review
Version Control

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

Environmental

Air Management
Auditing
Compliance Management
Document Management
Emissions Inventory
Hazardous Materials Control
Sustainability Management
Training Management
Waste Management
Water Management

ESG

Activity Dashboard
Analytics/Reporting
Audit Management
Benchmarking
Compliance Management
Data Visualization
Document Management
Performance Metrics
Risk Assessment

Integrated Risk Management

Audit Management
Compliance Management
Dashboard
Disaster Recovery
IT Risk Management
Incident Management
Operational Risk Management
Risk Assessment
Safety Management
Vendor Management

Product Lifecycle Management

Change Management
Compliance Management
Cost Tracking
Design Management
Document Management
Product Data Management
Project Management
Requirements Management
Supplier 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

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

Safety Management

Audit Management
Corrective / Preventive Actions
Incident Management
Injury Reporting
Inspection Management
OSHA Recordkeeping
Safety Risk Assessment
Training Management

Sustainability

Audit Management
Benchmarking
Compliance Management
Corrective Actions (CAPA)
Emissions Management
Employee Training
Energy Management
Incident Management
KPIs
Performance Metrics
Stakeholder Engagement
Supplier Management
Waste Management

Waste Management

Billing & Invoicing
Customer Accounts
Customer Database
Equipment Tracking
Inventory Management
Routing
Scheduling
Waste Disposal
Work Order Management

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

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