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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

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 

Screenshots View All

Screenshots View All

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 
Google Cloud Operations Suite Yes 
HubSpot CRM Yes 
Intercom Yes 
Microsoft OneDrive Yes 
Okta Yes 
RegDesk Yes 
SSOJet Yes 
Salesforce Yes 
TestRail Yes 
Zephyr 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 
Google Cloud Operations Suite No 
HubSpot CRM No 
Intercom No 
Microsoft OneDrive No 
Okta No 
RegDesk No 
SSOJet No 
Salesforce No 
TestRail 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

$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 

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