Average Ratings 919 Ratings
Average Ratings 0 Ratings
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
No
API Access
Has API
No
Integrations
Asana
Yes
Azure DevOps
Yes
Azure DevOps Labs
Yes
Azure DevOps Server
Yes
Azure-AD-External-Identities
Yes
Dynamics 365 Customer Service
Yes
Essenvia
Yes
GitHub
Yes
GitHub Advanced Security
Yes
GitLab
Yes
Integrations
Asana
No
Azure DevOps
No
Azure DevOps Labs
No
Azure DevOps Server
No
Azure-AD-External-Identities
No
Dynamics 365 Customer Service
No
Essenvia
No
GitHub
No
GitHub Advanced Security
No
GitLab
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
$99 per user per month
Free Trial
No
Free Version
Yes
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
No
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
Rumzer Compliance Software
Country
United States
Website
rumzer.com/product.html
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