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Average Ratings 919 Ratings

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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

We are a team of innovative designers and exceptional developers who are passionate about harnessing the full potential of technology. Since our inception in 1995, we have consistently delivered outstanding solutions that embody our commitment to excellence. We take great pride in our legacy and invite you to join us in this journey. Experience the T3 Group firsthand and see the difference! Whether at your location or ours, we offer the flexibility to either create solutions from the ground up or enhance existing systems. Our projects vary in scale, and we provide a dedicated development team to support you every step of the way. Additionally, we offer a staff augmentation approach, integrating our experts directly with your team on-site to foster collaboration. Many believe our team is unparalleled in the industry – come and discover the truth for yourself! With our extensive experience, we are eager to tackle your challenges and bring your vision to life.

API Access

Has API No 

API Access

Has API No 

Screenshots View All

Screenshots View All

Integrations

Auth0 Yes 
Azure AI Document Intelligence Yes 
Azure DevOps Yes 
Azure DevOps Labs Yes 
Azure-AD-External-Identities Yes 
Essenvia Yes 
GitHub Yes 
GitHub Desktop Yes 
Google Cloud Operations Suite Yes 
HubSpot CRM Yes 
Jira Yes 
Marigold Engage+ No 
Microsoft OneDrive Yes 
Okta Yes 
RegDesk Yes 
SSOJet Yes 
Salesforce Yes 
Xray Yes 
Zendesk Yes 
Zephyr Yes 

Integrations

Auth0 No 
Azure AI Document Intelligence No 
Azure DevOps No 
Azure DevOps Labs No 
Azure-AD-External-Identities No 
Essenvia No 
GitHub No 
GitHub Desktop No 
Google Cloud Operations Suite No 
HubSpot CRM No 
Jira No 
Marigold Engage+ Yes 
Microsoft OneDrive No 
Okta No 
RegDesk No 
SSOJet No 
Salesforce No 
Xray No 
Zendesk No 
Zephyr 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 

Pricing Details

No price information available.
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) Yes 
Online Support Yes 

Customer Support

Business Hours Yes 
Live Rep (24/7) No 
Online Support Yes 

Types of Training

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

Types of Training

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

Vendor Details

Company Name

Qualio

Founded

2010

Country

United States

Website

www.qualio.com

Vendor Details

Company Name

T3 Group

Website

t3core.com

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 

Product Features

Policy Management

Approval Process Control No 
Attestation No 
Audit Trails No 
Policy Creation No 
Policy Library No 
Policy Metadata Management No 
Policy Training No 
Reporting / Analytics Yes 
Version Control No 
Workflow Management Yes 

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