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What is qmsWrapper?

qmsWrapper is a connected Quality Management System (eQMS) designed specifically for medical device startups and SMEs. Instead of implementing a complex enterprise platform from day one, companies can start with Foundation and expand to Lifecycle and Vigilance as their quality system matures. Built for ISO 13485, ISO 14971, FDA QMSR, FDA 21 CFR Part 11, and EU MDR, qmsWrapper connects document control, training, CAPA, quality events, risk management, technical documentation, supplier quality, and traceability in one platform. AI assists users with quality processes while every action remains human-controlled and fully auditable. Start where the need is greatest. Keep everything you build. Grow your QMS without rebuilding or migrating to another system.

What is SolvoNext NCR CAPA?

SolvoNext – NCR CAPA is a complete digital solution for managing non-conformance reporting and corrective & preventive actions, tailored to the needs of modern factories. It transforms the traditional, paper-heavy processes into an organized, streamlined workflow that increases accountability and speeds up resolution. The system’s step-by-step structure begins with NCR initiation and containment, followed by root cause analysis using embedded tools like the 5 Whys and Fishbone diagrams, financial impact recording, and final approvals. Powerful dashboards display actionable insights, allowing leaders to track NCR status, monitor monthly trends, and analyze departmental performance in real time. Its COPQ (Cost of Poor Quality) tracking capability calculates labor, material, and waste costs, helping manufacturers prioritize quality improvements with measurable ROI. Role-based access control and automated notifications keep the right stakeholders informed at every stage, reducing delays and communication gaps. With optional AI capabilities, SolvoNext offers predictive analytics, pattern detection, advanced process mapping, and automated reports for even deeper operational insight. Deployment is flexible, supporting AWS cloud hosting, on-premise servers, or hybrid environments. The system can also be customized for multi-plant operations or unique industry requirements. By digitizing NCR and CAPA processes, SolvoNext drives higher product quality, lower operational costs, and a more efficient manufacturing culture.

Media

Media

No images available

Integrations Supported

Jira

Integrations Supported

Jira

API Availability

Has API

API Availability

Has API

Pricing Information

€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 Version
Free Trial Offered?

Pricing Information

Pricing not provided
Free Version
Free Trial Offered?

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

qmsWrapper

Company Location

Canada

Company Website

www.qmswrapper.com

Company Facts

Organization Name

ORCA LEAN

Date Founded

2021

Company Location

United States

Company Website

www.orcalean.com/solvonext-ncr

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

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

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