QEdgeSarjen Systems Pvt Ltd
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Related Products
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About
Sarjen’s Quality Management Software brings meaningful digital transformation to how quality is managed across regulated manufacturing environments. More than just a system to store compliance records, it uses AI to turn quality data into actionable insights. AI analyzes trends, spots early signals of deviation, and predicts potential quality risks before they impact products or processes. Automated alerts and intelligent recommendations help teams act faster, reduce manual errors, and strengthen decision-making with context-aware guidance. With machine learning, the system continuously learns from data patterns and improves accuracy over time. By combining robust quality workflows with AI-driven intelligence, the solution enhances product consistency, accelerates investigation cycles, and ensures stronger compliance. It makes quality management smarter, more proactive, and easier for your teams to adopt and trust.
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About
qmsWrapper is a connected Quality Management System (eQMS) built specifically for medical device startups and SMEs. Instead of implementing a complex enterprise platform from day one, organizations can grow their QMS through three connected editions: Foundation, Lifecycle, and Vigilance.
Foundation helps companies move from paper forms, Word documents, and spreadsheets to controlled documents, workflows, training, and AI-assisted quality processes. Lifecycle adds CAPA, Quality Events, Change Control, Risk Management, Technical File management, Supplier Quality, and Smart Traceability Matrix. Vigilance extends the platform with post-market surveillance, regulatory oversight, audit readiness, and AI governance.
Built for ISO 13485, ISO 14971, FDA QMSR, FDA 21 CFR Part 11, and EU MDR, qmsWrapper helps companies scale their quality system without rebuilding or migrating to another platform.
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Platforms Supported
Windows
Supported
Mac
Not Supported
Linux
Not Supported
Cloud
Supported
On-Premises
Supported
iPhone
Not Supported
iPad
Not Supported
Android
Not Supported
Chromebook
Not Supported
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Platforms Supported
Windows
Supported
Mac
Supported
Linux
Supported
Cloud
Supported
On-Premises
Not Supported
iPhone
Not Supported
iPad
Not Supported
Android
Not Supported
Chromebook
Not Supported
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Audience
Companies searching for a solution to optimize the quality of various processes
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Audience
Medical Device Companies, MedTech Startups, SaMD, eQMS, ISO 13485, ISO 14971, FDA QMSR, EU MDR, Quality Management, Regulatory Affairs, Quality Assurance, CAPA, Risk Management, Technical File, Traceability
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Support
Phone Support
Supported
24/7 Live Support
Supported
Online
Supported
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Support
Phone Support
Not Supported
24/7 Live Support
Not Supported
Online
Supported
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API
Offers API
Not Supported
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API
Offers API
Not Supported
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Screenshots and Videos |
Screenshots and Videos |
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PricingFor more detail contact at Sarjen systems website contact page
Free Version
Not Supported
Free Trial
Not Supported
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Pricing
€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
Not Supported
Free Trial
Supported
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Reviews/
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Reviews/
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Pros & Cons from Real UsersPros
Cons
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Training
Documentation
Supported
Webinars
Supported
Live Online
Supported
In Person
Supported
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Training
Documentation
Supported
Webinars
Not Supported
Live Online
Supported
In Person
Not Supported
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Company InformationSarjen Systems Pvt Ltd
Founded: 1998
India
qedge.sarjen.com
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Company InformationqmsWrapper
Canada
www.qmswrapper.com
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Categories |
Categories |
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Quality Management Features
Audit Management
Supported
Complaint Management
Supported
Compliance Management
Supported
Corrective and Preventive Actions (CAPA)
Supported
Defect Tracking
Not Supported
Document Control
Supported
Equipment Management
Supported
ISO Standards Management
Not Supported
Maintenance Management
Not Supported
Risk Management
Not Supported
Supplier Quality Control
Supported
Training Management
Supported
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Quality Management Features
Audit Management
Supported
Complaint Management
Supported
Compliance Management
Supported
Corrective and Preventive Actions (CAPA)
Supported
Defect Tracking
Supported
Document Control
Supported
Equipment Management
Not Supported
ISO Standards Management
Supported
Maintenance Management
Not Supported
Risk Management
Supported
Supplier Quality Control
Supported
Training Management
Supported
CAPA Features
Audit Management
Supported
CAPA Planning
Supported
Change Management
Supported
Complaint Management
Supported
Incident Management
Not Supported
Nonconformance Tracking
Supported
Quality Control
Supported
Risk Management
Supported
Root Cause Analysis
Supported
Training Management
Supported
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