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What is SILKROAD ALM?

SILKROAD ALM is an all-encompassing application lifecycle management solution tailored for software projects that require exceptional reliability. Drawing its name from the historic "Silk Road," it symbolizes a vast network of trade routes that once connected Asia and Europe. This platform seamlessly integrates numerous legacy management tools, including those for requirements gathering, design, configuration management, and testing, which simplifies the development process for users. Developers often encounter obstacles when trying to produce highly reliable software because of the absence of a centralized tool that oversees the complete development lifecycle, from initial requirements gathering through to testing. SILKROAD addresses this issue by providing a comprehensive perspective on the software development process. The analysis phase consists of a systematic breakdown of requirements elicitation, fostering a more profound understanding of each requirement, and accommodating their representation in various complementary formats. By improving the comprehension and oversight of requirements, SILKROAD ALM significantly boosts the productivity and effectiveness of software development teams, ultimately leading to better outcomes. The system's emphasis on integration and clarity makes it an invaluable asset in the fast-evolving landscape of software development.

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

Integrations Supported

Jira
Microsoft 365
Salesforce

API Availability

API Availability

Pricing Information

Pricing not provided
Free Version

Pricing Information

Pricing not provided
Free Version
Free Trial Offered?

Supported Platforms

Windows

Supported Platforms

SaaS
Android
Windows

Customer Service / Support

Standard Support

Customer Service / Support

Standard Support
Web-Based Support

Training Options

Webinars

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

NSE Technology

Date Founded

2011

Company Location

South Korea

Company Website

www.silkroadalm.com/main.do

Company Facts

Organization Name

Orcanos

Date Founded

2004

Company Location

Israel

Company Website

www.orcanos.com

Categories and Features

Application Lifecycle Management

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

Requirements Management

Change Management
Reporting
Status Tracking
Task Management

Risk Management

Not specified

Workflow Management

Access Controls/Permissions
Business Process Automation
Calendar Management
Compliance Tracking
Mobile Access
Task Management
Third Party Integrations
Workflow Configuration

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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