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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

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

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
Essenvia
GitHub
GitHub Advanced Security
GitHub Desktop
GitLab
GitLab Duo
Intercom
Jira
Microsoft Dynamics 365
Microsoft OneDrive
Okta
Salesforce
Xray
Zendesk

Integrations

Asana
Auth0
Azure AI Document Intelligence
Azure DevOps
Azure DevOps Labs
Azure DevOps Server
Essenvia
GitHub
GitHub Advanced Security
GitHub Desktop
GitLab
GitLab Duo
Intercom
Jira
Microsoft Dynamics 365
Microsoft OneDrive
Okta
Salesforce
Xray
Zendesk

Pricing Details

No price information available.
Free Trial
Free Version

Pricing Details

$500.00/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

ZetaSafe

Website

www.zetasafe.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

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

Product Features

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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