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
Whether you are providing services or overseeing your own compliance needs, ZetaSafe is here to assist you in fulfilling your compliance requirements, ensuring the safety and security of your personnel and facilities. We are excited to share that Micad has successfully acquired Zeta Compliance Technologies LLC (SEER), the North American distributor of ZetaSafe software. With ZetaSafe, you can effortlessly track and manage your compliance responsibilities with high precision. This solution offers enhanced oversight of data, costs, labor, and operational procedures. Additionally, it features a comprehensive audit trail that provides reassurance that all necessary monitoring is conducted punctually. You will also gain real-time insights into your data, key performance indicators, and emerging trends. The system's automatic escalation of non-compliance issues allows for prompt and effective management of any failures or defects. It covers important regulations such as HSG274, HTMs (including HTM 04:01), the RRO Fire Safety 2005, and SFG20. Take the opportunity to book a demo and discover how ZetaSafe can optimize your processes. With capabilities to scan barcodes, input compliance data, and generate insightful trends and reports, ZetaSafe works alongside you to evaluate your compliance management strategies and tailor the software to meet your specific compliance needs. Collaborating with you ensures that all aspects of your compliance are meticulously managed and maintained.
API Access
Has API
No
API Access
Has API
No
Integrations
Asana
Yes
Auth0
Yes
Azure DevOps
Yes
Azure DevOps Labs
Yes
ComplianceWire
Yes
Dynamics 365 Customer Service
Yes
GitHub
Yes
GitHub Advanced Security
Yes
GitHub Desktop
Yes
GitLab Duo
Yes
Integrations
Asana
No
Auth0
No
Azure DevOps
No
Azure DevOps Labs
No
ComplianceWire
No
Dynamics 365 Customer Service
No
GitHub
No
GitHub Advanced Security
No
GitHub Desktop
No
GitLab Duo
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
$500.00/month
Free Trial
No
Free Version
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
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
Yes
iPad App
Yes
Android App
Yes
Windows
Yes
Mac
Yes
Linux
No
Chromebook
No
Customer Support
Business Hours
Yes
Live Rep (24/7)
Yes
Online Support
Yes
Customer Support
Business Hours
Yes
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
No
Webinars
Yes
Live Training (Online)
Yes
In Person
Yes
Vendor Details
Company Name
Qualio
Founded
2010
Country
United States
Website
www.qualio.com
Vendor Details
Company Name
ZetaSafe
Website
www.zetasafe.com
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
Product Features
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
No
Training Management
No