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Average Ratings 10 Ratings

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support

Description

Sarjen’s Quality Management Software brings transformative intelligence to how organisations manage quality, compliance, and continuous improvement. Built for regulated industries like pharmaceuticals, life sciences, and manufacturing, this solution goes beyond traditional quality systems by embedding AI at its core. Rather than merely storing documents and checklists, AI continuously analyses quality data from processes, deviations, audits, customer feedback, and supplier performance to surface meaningful patterns and risks. By leveraging machine learning, the system identifies early signals of quality drift that manual reviews can miss, and predicts potential non-conformances before they escalate into serious issues.AI-driven insights provide context-aware recommendations that empower quality teams to act smarter and faster, reducing investigation cycles and eliminating repetitive manual work. Intelligent alerts help prioritise what matters most, while automated trend analysis highlights areas for improvement without waiting for periodic reviews. The software also supports root cause analysis with AI-augmented suggestions, helping teams uncover hidden correlations across data sources.With built-in compliance workflows and adaptive quality controls, the system ensures consistent adherence to industry regulations while learning from operational data to become more accurate over time. Through advanced visualisation, interactive dashboards, and predictive quality metrics, stakeholders get a real-time understanding of quality health at every level of the business. The result is a proactive, resilient quality ecosystem where AI amplifies human expertise rather than replacing it.

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

API Access

Has API

Screenshots View All

Screenshots View All

Integrations

Jira
SAP Store

Integrations

Jira
SAP Store

Pricing Details

For more detail contact at Sarjen systems website contact page
Free Trial
Free Version

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
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

Sarjen Systems Pvt Ltd

Founded

1998

Country

India

Website

qedge.sarjen.com

Vendor Details

Company Name

qmsWrapper

Country

Canada

Website

www.qmswrapper.com

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

Product 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

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