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Average Ratings 858 Ratings

Description

Compliance & Risks works closely with some of the most prominent brands in the world, including Dyson, Stryker, Kodak, Lenovo and Samsung. We simplify the ESG and Product Compliance process to unlock market access. Three key elements are part of our offering: 1. Enterprise technology solution to improve productivity and efficiency with C2P 2. The market's most comprehensive regulatory content, with 40+ topics covering over 20+ industries and 195 nations worldwide 3. A team of subject matter experts are available to answer any regulatory questions you may have We help you to monitor and assess the relevant regulations and standards that apply to your products and business. We also help you prove ESG and product compliance in order for your business to remain on the market and grow. We have over 20 years experience working with some of the most iconic brands in the world and have a remarkable track record of helping companies to manage compliance risks more effectively than ever.

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

Asana
Auth0
Azure AI Document Intelligence
Azure DevOps
Azure DevOps Labs
Azure DevOps Server
Azure-AD-External-Identities
Dynamics 365 Customer Service
GitHub
GitHub Advanced Security
GitLab
Google Cloud Operations Suite
HubSpot CRM
Jira
Microsoft 365
Microsoft Dynamics 365
Microsoft OneDrive
Salesforce
Xray
Zephyr

Integrations

Asana
Auth0
Azure AI Document Intelligence
Azure DevOps
Azure DevOps Labs
Azure DevOps Server
Azure-AD-External-Identities
Dynamics 365 Customer Service
GitHub
GitHub Advanced Security
GitLab
Google Cloud Operations Suite
HubSpot CRM
Jira
Microsoft 365
Microsoft Dynamics 365
Microsoft OneDrive
Salesforce
Xray
Zephyr

Pricing Details

No price information available.
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

Compliance and Risks

Founded

2000

Country

Ireland

Website

www.complianceandrisks.com

Vendor Details

Company Name

Qualio

Founded

2010

Country

United States

Website

www.qualio.com

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

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

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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