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What is QEdge?

Sarjen’s Quality Management Software transforms how organizations approach quality by infusing advanced AI capabilities into every aspect of quality processes. Designed for regulated industries like pharmaceuticals and life sciences, the platform goes well beyond traditional record-keeping and compliance checklists. At its heart, AI continuously ingests and analyzes quality data from across your operations — from batch records and deviations to CAPAs and audit trails — turning extensive information into meaningful, predictive insights.AI-driven analytics detect early patterns and subtle anomalies that might be missed by manual review, helping teams identify risks before they escalate into costly issues. With intelligent trend analysis, the system highlights recurring quality challenges and suggests preventative actions, making it easier to strengthen processes proactively rather than reactively. Predictive models also foresee potential compliance gaps, enabling organizations to take corrective measures ahead of time, saving both time and resources.Natural language processing enhances the investigation experience by summarizing complex reports and recommending relevant similar cases, while machine learning continuously improves accuracy as it learns from new data. Automated alerts, guided workflows, and contextual recommendations empower quality teams to act with confidence, reduce manual errors, and make decisions grounded in real-time intelligence.By unifying AI with core quality modules — including deviations, CAPA, change control, audit management, and document control — Sarjen’s solution enhances operational visibility and speeds up resolution cycles. The AI features not only boost efficiency but also foster a culture of continuous improvement, enabling organizations to adapt swiftly to evolving regulatory demands. Ultimately, this AI-led transformation strengthens product quality, increases compliance readiness, and equips teams with the smart tools.

What is Orcanos?

Orcanos is a unified eQMS and ALM platform designed specifically for medical device companies that need to manage regulated product development and quality operations together. The platform helps R&D, Quality, Regulatory, and Operations teams work from a single source of truth instead of relying on disconnected documents, spreadsheets, and siloed systems. Orcanos connects design control, quality management, document control, risk management, requirements, testing, validation, training, and audit evidence across the full medical device lifecycle. Its eQMS capabilities support quality processes such as document approvals, revision control, electronic signatures, training automation, CAPA, complaints, audits, nonconformances, and compliance records. Its ALM and design control tools help teams manage user needs, design inputs, risks, mitigations, verification, validation, DHF documentation, and automated impact analysis. Orcanos supports key medical device compliance needs, including ISO 13485, EU MDR, ISO 14971, FDA expectations, and 21 CFR Part 11 requirements. The platform is built for adaptive compliance, allowing teams to configure workflows, forms, fields, status flows, permission structures, and approval processes without heavy coding. Document control features help automate lifecycle routing, publishing, archiving, read-and-understand training tasks, and audit trails for every revision. Risk management becomes a live process by linking hazards, requirements, mitigations, design changes, and verification evidence in real time instead of maintaining static Excel files. Orcanos also includes Ask Paul, an AI-powered assistant designed to help users work more efficiently across regulated quality and development activities. With rapid implementation, traceability, configurable workflows, and centralized compliance data, Orcanos helps medical device teams reduce regulatory friction, stay audit-ready, and bring safer products to market faster.

Media

Media

Integrations Supported

SAP Store

Integrations Supported

Jira
Microsoft 365
Salesforce

API Availability

API Availability

Pricing Information

For more detail contact at Sarjen systems website contact page

Pricing Information

Pricing not provided
Free Version
Free Trial Offered?

Supported Platforms

SaaS
Windows
On-Prem

Supported Platforms

SaaS
Android
Windows

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard 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

Sarjen Systems Pvt Ltd

Date Founded

1998

Company Location

India

Company Website

qedge.sarjen.com

Company Facts

Organization Name

Orcanos

Date Founded

2004

Company Location

Israel

Company Website

www.orcanos.com

Categories and Features

Quality Management

Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Document Control
Equipment Management
Supplier Quality Control
Training Management

Categories and Features

Application Lifecycle Management

Administrator Level Control
Defect Tracking
Iteration Planning
Project Management
Release Management
Requirements Review
Task Management
Test Case Tracking
User Level Management
Version Control

Audit

Not specified

CAPA

Not specified

Compliance

Not specified

Document Control

Not specified

Quality Management

Not specified

Requirements Management

Change Management
Collaboration
History Tracking
Prioritization
Reporting
Status Reporting
Status Tracking
Summary Reports
Task Management
To-Do List
Traceability
User Defined Attributes

Risk Management

Not specified

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