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What is Qualio?
Qualio is a unified quality and compliance platform that helps growing life sciences companies scale faster while staying continuously audit- and inspection-ready. Medical device, digital health, biotech, and pharma teams use Qualio to replace manual processes and disconnected tools with a single source of truth for quality, regulatory readiness, and risk.
With a modern eQMS at the foundation and Compliance Intelligence layered on top, Qualio moves teams beyond point-in-time audits. Automated gap analysis, cross-standard evidence mapping, and real-time readiness dashboards provide confidence that the organization is prepared today—not just when auditors arrive.
Qualio centralizes document control, training, CAPA, change management, supplier quality, and design controls, linking them directly to regulatory requirements and product lifecycle data. Executive-ready views show compliance health by standard, region, and product, turning regulatory readiness into a measurable business capability instead of a black box.
Compliance Intelligence continuously monitors for risk, highlights gaps early, and prioritizes remediation so teams focus effort where it matters most. Pre-validated regulatory frameworks are maintained as requirements evolve, reducing reliance on consultants and avoiding duplicate work as companies expand.
The result is faster market entry, lower compliance cost, reduced risk of findings or recalls, and confident, risk-managed growth.
What is BPAQuality365?
BPAQuality365 is a quality management system (QMS) software that operates within the secure environment of Microsoft 365 cloud. It utilizes familiar tools that your team already engages with daily, eliminating the need for any alterations to user habits. This modern software is versatile, functioning seamlessly across all devices while being tailored to meet your specific requirements, and it harnesses the latest M365 technologies. The application boasts robust features for managing compliance documents, conducting audits, tracking non-conformances, implementing CAPA actions, and handling processes, process maps, incidents, changes, risks, FMEA, SWOT analyses, equipment, and health, safety, and environmental modules in adherence to ISO 9001, FDA Part 11, and medical regulations. Furthermore, the QMS application integrates smoothly with Teams, allowing users to inquire about the QMS during discussions and easily share QMS cards with colleagues. You can elevate your endeavors toward Quality 4.0 by leveraging advanced AI capabilities alongside superior workflow automation and insightful business intelligence. BPA's status as a Microsoft Preferred partner enables you to tailor your QMS according to your unique demands, collaborate effectively with power users, and deepen your understanding of M365 technologies, ultimately enhancing your organization's overall efficiency and compliance.
Integrations Supported
Microsoft 365
Asana
Auth0
Azure AI Anomaly Detector
Azure AI Document Intelligence
Azure DevOps
Azure DevOps Server
Azure-AD-External-Identities
Essenvia
GitHub
Integrations Supported
Microsoft 365
Asana
Auth0
Azure AI Anomaly Detector
Azure AI Document Intelligence
Azure DevOps
Azure DevOps Server
Azure-AD-External-Identities
Essenvia
GitHub
API Availability
Has API
API Availability
Has API
Pricing Information
Pricing not provided.
Free Trial Offered?
Free Version
Pricing Information
Pricing not provided.
Free Trial Offered?
Free Version
Supported Platforms
SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux
Supported Platforms
SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux
Customer Service / Support
Standard Support
24 Hour Support
Web-Based Support
Customer Service / Support
Standard Support
24 Hour Support
Web-Based Support
Training Options
Documentation Hub
Webinars
Online Training
On-Site Training
Training Options
Documentation Hub
Webinars
Online Training
On-Site Training
Company Facts
Organization Name
Qualio
Date Founded
2010
Company Location
United States
Company Website
www.qualio.com
Company Facts
Organization Name
BPA Solutions
Date Founded
2001
Company Location
US/Switzerland
Company Website
www.bpa-solutions.net/software/office365-quality-app/
Categories and 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
Categories and Features
CAPA
Audit Management
CAPA Planning
Change Management
Complaint Management
Incident Management
Nonconformance Tracking
Quality Control
Risk Management
Root Cause Analysis
Training Management
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
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