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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 Adherent?

Adherent is an agentic AI platform for product compliance, built to help global companies stay ahead of changing regulations and manage compliance across markets. Formerly known as Compliance & Risks, Adherent combines AI automation with human-verified regulatory intelligence to support trusted compliance decision-making. The platform helps teams monitor product compliance, assess regulatory applicability, identify compliance requirements, prioritize business risk, and manage regulations, standards, requirements, and evidence. Its AI agents handle much of the heavy lifting by tracking regulatory changes, mapping requirements to products, extracting obligations, and identifying risks that need attention first. Adherent is designed for regulated enterprises that require explainable insights, auditable outputs, and strong controls rather than generic AI responses. Ari, the platform’s AI product compliance assistant, acts as a digital teammate that helps execute compliance workflows while experts focus on higher-value strategy. The platform supports compliance needs across corporate compliance, sustainability compliance, C2P compliance, regulations management, standards management, requirements management, and evidence management. It also supports industry-specific requirements for apparel, textiles, footwear, automotive, consumer electronics, cosmetics, household appliances, industrial machinery, medical devices, online retailers, marketplaces, power tools, garden machinery, and toys. Adherent’s regulatory database is verified by global compliance specialists, giving teams access to structured intelligence with human oversight. Customer use cases include horizon scanning, market access, regulatory assessments, compliance monitoring, operational insights, risk prioritization, compliance auditing, and capacity management.

Media

Media

Integrations Supported

Asana
Azure AI Document Intelligence
Azure DevOps
Azure DevOps Labs
ComplianceWire
Essenvia
GitHub
GitLab
GitLab Duo
Google Cloud Operations Suite
Intercom
Jira
Microsoft 365
Microsoft Dynamics 365
Microsoft OneDrive
Okta
TestRail
Xray
Zendesk
Zephyr

Integrations Supported

Asana
Azure AI Document Intelligence
Azure DevOps
Azure DevOps Labs
ComplianceWire
Essenvia
GitHub
GitLab
GitLab Duo
Google Cloud Operations Suite
Intercom
Jira
Microsoft 365
Microsoft Dynamics 365
Microsoft OneDrive
Okta
TestRail
Xray
Zendesk
Zephyr

API Availability

Has API

API Availability

Has API

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Pricing Information

Pricing not provided.
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

Adherent

Date Founded

2000

Company Location

Ireland

Company Website

www.adherent.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

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

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

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