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Average Ratings 919 Ratings

Description

CAQ.Net software solutions are in action all around the globe wherever it is important to ensure the quality, safety, and functionality of products and services. Whether strategic quality management or operational quality assurance – thanks to its high degree of automation and uniform data structure, CAQ.Net facilitates effective process management, proactive failure prevention, and a company-wide quality mindset.

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 Yes 

API Access

Has API No 

Screenshots View All

Screenshots View All

Integrations

Microsoft 365 Yes 
APplus Yes 
Asana No 
Azure DevOps Server No 
Dynamics 365 Customer Service No 
GitHub No 
GitHub Advanced Security No 
GitLab No 
IFS Yes 
Intercom No 
Jira No 
MeasurLink Yes 
Microsoft Dynamics 365 No 
Okta No 
Proalpha Yes 
Salesforce No 
TestRail No 
Xray No 
ZEISS Software Yes 
abas ERP Yes 

Integrations

Microsoft 365 Yes 
APplus No 
Asana Yes 
Azure DevOps Server Yes 
Dynamics 365 Customer Service Yes 
GitHub Yes 
GitHub Advanced Security Yes 
GitLab Yes 
IFS No 
Intercom Yes 
Jira Yes 
MeasurLink No 
Microsoft Dynamics 365 Yes 
Okta Yes 
Proalpha No 
Salesforce Yes 
TestRail Yes 
Xray Yes 
ZEISS Software No 
abas ERP No 

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 Yes 
iPhone App No 
iPad App No 
Android App No 
Windows Yes 
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) Yes 
Online Support Yes 

Customer Support

Business Hours Yes 
Live Rep (24/7) Yes 
Online Support Yes 

Types of Training

Training Docs Yes 
Webinars Yes 
Live Training (Online) Yes 
In Person Yes 

Types of Training

Training Docs Yes 
Webinars Yes 
Live Training (Online) Yes 
In Person No 

Vendor Details

Company Name

CAQ AG Factory Systems

Founded

1993

Country

Germany

Website

www.caq.net/en

Vendor Details

Company Name

Qualio

Founded

2010

Country

United States

Website

www.qualio.com

Product Features

Audit

Alerts / Notifications Yes 
Audit Planning Yes 
Compliance Management Yes 
Dashboard Yes 
Exceptions Management Yes 
Forms Management No 
Issue Management No 
Mobile Access Yes 
Multi-Year Planning Yes 
Risk Assessment Yes 
Workflow Management Yes 

Calibration Management

Calibration Instructions No 
Calibration Schedules Yes 
Compliance Management Yes 
Device History Yes 
Due Date Tracking Yes 
Gage Management Yes 
Label Printing Yes 
Measurement Readings Yes 
Multi-Station Management Yes 
Out-of-Tolerance Notification Yes 
Statistical Data Reporting Yes 

CAPA

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

Change Management

Approval Workflow Yes 
Audit Trail Yes 
Automated Notifications No 
Change Calendar Yes 
Change Planning Yes 
Compliance Management Yes 
Prioritization Yes 
Release Management No 
Task Management Yes 
Tracking & Reporting No 
Training Management Yes 

Chemical

Certificates of Analysis Yes 
Chemical Process Simulation No 
Computer-Assisted Structure Elucidation (CASE) No 
ISO Management Yes 
Inventory Management Yes 
Particle Tracking No 
Reporting & Statistics Yes 
Samples Tracking Yes 
Traceability Yes 
Uncertainty Analysis No 

CMMS

Asset Tracking No 
Calibration Management Yes 
Inventory Control Yes 
Key & Lock Management No 
Mobile Access No 
Preventive Maintenance Yes 
Purchasing No 
Scheduling Yes 
Service History Tracking Yes 
Technician Management Yes 
Work Order Management Yes 

Complaint Management

Case Management No 
Complaint Classification Yes 
Corrective Actions (CAPA) Yes 
Customer Complaint Tracking Yes 
Feedback Management No 
Forms Management No 
Issue Tracking No 
Quality Assurance Management Yes 
Routing No 
Self Service Portal No 
Social Media Monitoring No 
Survey Management No 

Document Control

Archiving & Retention Yes 
Automated Routing Yes 
Change Management Yes 
Compliance Management Yes 
Electronic Signature Yes 
Escalation Management Yes 
Periodic Review No 
Version Control Yes 

LIMS

Audit Trail Yes 
Certificates of Analysis Yes 
Data Import / Export Yes 
Electronic Laboratory Notebook No 
Inventory Management Yes 
Lab Instrument Interface No 
Reporting & Statistics Yes 
Sample Tracking Yes 
Specification Management 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 

Risk Management

Alerts/Notifications Yes 
Auditing Yes 
Business Process Control Yes 
Compliance Management Yes 
Corrective Actions (CAPA) Yes 
Dashboard Yes 
Exceptions Management No 
IT Risk Management No 
Internal Controls Management Yes 
Legal Risk Management No 
Mobile Access No 
Operational Risk Management Yes 
Predictive Analytics No 
Reputation Risk Management No 
Response Management No 
Risk Assessment Yes 

SPC

Corrective Actions (CAPA) Yes 
Data Entry Yes 
Data Linking Yes 
Data Management Yes 
Excel Loader No 
Job Management Yes 
OPC Data Collection No 
Performance Metrics Yes 
Point-of-Production Analysis Yes 
Real Time Data Collection Yes 
Regulatory Compliance Yes 

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 

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