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QualioQualio 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
Qualtrax is a quality and compliance software program that can manage and control documentation, automate key business processes, streamline training management, manage external and internal audits, and ensure that critical industry regulations are met in real time. Qualtrax is a valuable resource in highly-regulated industries where compliance with standards such as ISO 17025 and 17020, 13485 and 9001, TNI and GFSI, FDA and FQS are required.
Description
WoodWing Scienta is a cloud-based quality management system (QMS) that combines quality management, process management and knowledge management in one structured environment. It is designed for quality, QHSE, compliance and operations teams, while remaining easy for employees across the organization to use.
Organizations can manage policies, procedures, work instructions, quality manuals, process flowcharts, digital forms, risks, incidents, suppliers, audits and improvement actions. Version control, ownership, permissions, approval workflows, recurring reviews and audit trails help keep information current, controlled and traceable. Employees can complete tasks, confirm reading assignments and submit change proposals when a documented process no longer matches daily practice.
Scienta AI Search lets users ask questions in natural language and receive answers based on approved content from their own Scienta environment. Existing access rights are respected and source information is shown with each answer. Digital forms and workflows support incident reporting, complaints, audits, checks and evaluations, while structured objects can be used to create registers for risks, suppliers, assets and corrective actions.
The Microsoft SharePoint integration allows Office files to remain managed in SharePoint while being presented within Scienta’s quality structure with context, ownership, permissions and workflow. Ready-to-use handbook content is available for ISO 9001, ISO 27001, healthcare quality and AI governance.
WoodWing Scienta is suitable for regulated and process-driven organizations, including healthcare providers, manufacturers, financial services firms, professional services organizations, associations and multi-location businesses.
API Access
Has API
API Access
Has API
Integrations
Brandwatch
Microsoft 365
Pricing Details
Pricing is determined on a per-user basis, with multiple license types available. Please contact us for a quote regarding your specific situation.
Free Trial
Free Version
Pricing Details
€53/month/5 users
WoodWing Scienta is offered as a subscription with three plans. Starter costs €53 per month and includes five employees. Advanced costs €146 per month and includes ten employees, while Ultimate costs €167 per month and includes ten employees. Plans differ in features such as AI Search usage, change proposals, Single Sign-On, public forms, statistics, RASCI and export templates. Support is included. A free 30-day trial is available and ends automatically. Organizations with additional users or specific onboarding requirements can contact WoodWing for a tailored quote.
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
Qualtrax
Founded
1993
Country
United States
Website
www.qualtrax.com
Vendor Details
Company Name
WoodWing
Founded
2000
Country
Netherlands
Website
www.woodwing.com/products/woodwing-scienta
Product Features
Accreditation Management
Collaboration
Compliance Management
Document Management
Higher Education
Requirements Management
Reviewer Portal
Self Assessment
User Access Permissions
Workflow Management
Audit
Alerts / Notifications
Audit Planning
Compliance Management
Dashboard
Exceptions Management
Forms Management
Issue Management
Mobile Access
Multi-Year Planning
Risk Assessment
Workflow 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
Document Control
Archiving & Retention
Automated Routing
Change Management
Compliance Management
Electronic Signature
Escalation Management
Periodic Review
Version Control
Document Management
Access Controls
Archiving & Retention
Collaboration Tools
Compliance Tracking
Document Archiving
Document Assembly
Document Capture
Document Conversion
Document Delivery
Document Indexing
Document Retention
Electronic Signature
Email Management
File Recovery
File Type Conversion
Forms Management
Full Text Search
Offline Access
Optical Character Recognition
Print Management
Version Control
Document Version Control
Access Controls/Permissions
Approval Process Control
Archiving & Retention
Audit Trail
Commenting / Notes
Document Check-in / Check-out
For Engineering Documents
Revision History
Version Comparison
Version Rollback
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
