Average Ratings 0 Ratings
Average Ratings 10 Ratings
Description
SolvoNext – NCR CAPA empowers small and medium-sized factories to replace outdated paper-based NCR and CAPA processes with a robust, digital-first solution. The platform guides teams through a structured workflow—starting with NCR initiation, moving through root cause analysis, recording financial data, and ending with secure approvals—all while maintaining a complete knowledge library. Interactive dashboards display key metrics like NCR status, departmental tracking, and monthly progress, helping leaders make quick, data-backed decisions. Its COPQ tracking feature calculates the financial toll of inefficiencies, waste, and defects, giving organizations a clearer view of quality performance. Built-in quality tools such as the 5 Whys and Fishbone diagrams make problem-solving systematic and collaborative. Users can assign role-based permissions, manage multi-level approvals, and receive automated alerts for faster communication. Optional AI integration enhances the platform with predictive analytics, advanced diagnostics, and automated reporting tailored to each plant’s needs. SolvoNext ultimately improves compliance, transparency, and operational efficiency across all manufacturing environments.
Description
qmsWrapper is a connected Quality Management System (eQMS) built for medical device startups and SMEs. It helps organizations move from paper forms, Word documents, and spreadsheets to a scalable, AI-enabled QMS that grows with their business through Foundation, Lifecycle, and Vigilance. Designed for ISO 13485, ISO 14971, FDA QMSR, FDA 21 CFR Part 11, and EU MDR, qmsWrapper connects documents, quality events, risk, training, CAPA, technical documentation, and traceability in one platform.
Best For:
- Medical device and SaMD companies implementing or modernizing an ISO 13485 QMS.
- Startups and SMEs that want to grow from controlled documents to connected quality workflows without replacing their QMS.
API Access
Has API
No
API Access
Has API
No
Screenshots View All
No images available
Integrations
Jira
No
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Pricing Details
€3,499
Foundation starts at €3,499 per year with unlimited users. Lifecycle and Vigilance pricing is available on request. All editions are designed to grow with your quality management needs without requiring migration to a new platform.
Free Trial
Yes
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
No
iPad App
No
Android App
No
Windows
Yes
Mac
Yes
Linux
Yes
Chromebook
No
Customer Support
Business Hours
Yes
Live Rep (24/7)
No
Online Support
No
Customer Support
Business Hours
No
Live Rep (24/7)
No
Online Support
Yes
Types of Training
Training Docs
No
Webinars
No
Live Training (Online)
No
In Person
No
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
Yes
In Person
No
Vendor Details
Company Name
ORCA LEAN
Founded
2021
Country
United States
Website
www.orcalean.com/solvonext-ncr
Vendor Details
Company Name
qmsWrapper
Country
Canada
Website
www.qmswrapper.com
Product Features
CAPA
Audit Management
No
CAPA Planning
No
Change Management
No
Complaint Management
No
Incident Management
No
Nonconformance Tracking
No
Quality Control
No
Risk Management
No
Root Cause Analysis
No
Training Management
No
Product Features
CAPA
Audit Management
Yes
CAPA Planning
Yes
Change Management
Yes
Complaint Management
Yes
Incident Management
No
Nonconformance Tracking
Yes
Quality Control
Yes
Risk Management
Yes
Root Cause Analysis
Yes
Training 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
No
ISO Standards Management
Yes
Maintenance Management
No
Risk Management
Yes
Supplier Quality Control
Yes
Training Management
Yes