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Average Ratings 858 Ratings

Average Ratings 0 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

In-app IMAP email and collaboration tools enhance your interactions with clients, vendors, and colleagues, making it easier to coordinate with all parties involved in compliance. Rumzerbot takes charge of keeping you updated on regulatory changes, allowing you to concentrate on running your business effectively. Every subscription plan provides updates regarding declarable substances and pertinent regulations. Rumzer empowers you to have better oversight of your compliance procedures and communication within your supply chain. We operate as your dedicated compliance software solution, eliminating the need for a middleman. You can conveniently manage all compliance-related emails in one centralized location. Setting up the system is as straightforward as configuring email on your mobile device—simply input your email credentials and you're ready to go. Users can be added or removed easily, and you can also integrate third-party service providers into your organization to assist with your compliance efforts. This flexibility ensures that your compliance management remains efficient and tailored to your specific needs.

API Access

Has API

API Access

Has API

Screenshots View All

Screenshots View All

Integrations

Asana
Azure AI Document Intelligence
Azure DevOps
Azure-AD-External-Identities
Dynamics 365 Customer Service
Essenvia
GitHub
GitLab
Intercom
Jira
Microsoft 365
Microsoft Dynamics 365
Microsoft OneDrive
Okta
RegDesk
Salesforce
TestRail
Xray
Zendesk
Zephyr

Integrations

Asana
Azure AI Document Intelligence
Azure DevOps
Azure-AD-External-Identities
Dynamics 365 Customer Service
Essenvia
GitHub
GitLab
Intercom
Jira
Microsoft 365
Microsoft Dynamics 365
Microsoft OneDrive
Okta
RegDesk
Salesforce
TestRail
Xray
Zendesk
Zephyr

Pricing Details

No price information available.
Free Trial
Free Version

Pricing Details

$99 per user per month
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

Qualio

Founded

2010

Country

United States

Website

www.qualio.com

Vendor Details

Company Name

Rumzer Compliance Software

Country

United States

Website

rumzer.com/product.html

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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