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What is aligned elements?

Aligned offers an integrated eQMS and design control for medical device and IVD organizations. The solution is engineered to help companies satisfy international regulatory expectations in a structured and efficient way, without adding unnecessary operational burden. The software aligns with major regulatory frameworks such as ISO 13485, FDA QSMR, EU MDR, and IVDR. It is used by professional teams who need reliable oversight of quality activities, product development, and regulatory documentation throughout the full lifecycle of their products. By uniting electronic quality processes and design control in one system, Aligned enables seamless collaboration across quality assurance, regulatory affairs, research and development, and executive functions. Product requirements, design records, verification and validation evidence, risk management activities, and controlled changes are inherently connected, providing continuous traceability and defensible documentation during audits and inspections.

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.

Media

Media

Integrations Supported

Apache Subversion
Azure DevOps Server
GitHub
GitLab
Jira Align
Redmine

Integrations Supported

API Availability

Has API

API Availability

Pricing Information

€1300 per year
See: 'How to buy' on our homepage for the full offer
Free Trial Offered?

Pricing Information

Pricing not provided
Free Version

Supported Platforms

SaaS
Windows
On-Prem

Supported Platforms

Windows

Customer Service / Support

Standard Support
Web-Based Support

Customer Service / Support

Standard Support

Training Options

Documentation Hub
Online Training
On-Site Training

Training Options

Webinars

Company Facts

Organization Name

Aligned AG

Date Founded

2007

Company Location

Switzerland

Company Website

www.aligned.ch/

Company Facts

Organization Name

NSE Technology

Date Founded

2011

Company Location

South Korea

Company Website

www.silkroadalm.com/main.do

Categories and Features

Application Lifecycle Management

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

Requirements Management

Automated Requirements QA
Automated Test Generation
Change Management
Collaboration
History Tracking
Prioritization
Reporting
Status Reporting
Status Tracking
Summary Reports
Task Management
To-Do List
Traceability
User Defined Attributes

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

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