Average Ratings 0 Ratings
Average Ratings 0 Ratings
Description
SILKROAD ALM serves as a comprehensive application lifecycle management system specifically designed for software that demands high reliability. Its name, inspired by the historical “Silk Road,” reflects a network of interconnected trade routes spanning Asia and Europe. This system integrates various legacy management tools including those for requirements, design, configuration management, and testing, allowing for seamless navigation through the development process. Many developers face challenges in creating highly reliable software due to the lack of a unified tool that oversees the entire development lifecycle from initial requirements to testing phases. SILKROAD aims to address this gap by offering a holistic view of the software development journey. The process of analysis consists of a methodical decomposition stemming from the elicitation of requirements, which leads to a deeper and clearer comprehension of each requirement while allowing for the representation of these requirements in diverse and complementary formats. By facilitating better understanding and management of requirements, SILKROAD ALM can significantly enhance the efficiency and effectiveness of software development teams.
Description
Aligned provides a purpose built eQMS and design management solution created exclusively for medical device and in vitro diagnostic manufacturers. It addresses the demands of global regulatory compliance while removing the friction typically associated with traditional QMS tools.
The system enables organizations to operate in line with key regulations and standards including ISO 13485, FDA QSMR, EU MDR, and IVDR. It is relied upon by experienced quality and development professionals who require transparency, control, and consistency across all stages of product development and post market activities.
Aligned brings quality management and design control together in a single coherent platform that supports cross functional teamwork. Quality, regulatory, R and D, and leadership teams work within the same controlled environment, where requirements, design data, verification and validation activities, risk files, and changes are inherently linked. This built in connectivity delivers complete traceability and clear evidence for audits, inspections, and regulatory submissions.
API Access
Has API
No
API Access
Has API
Yes
Integrations
Apache Subversion
No
Azure DevOps Server
No
GitHub
No
GitLab
No
Jira Align
No
Redmine
No
Integrations
Apache Subversion
Yes
Azure DevOps Server
Yes
GitHub
Yes
GitLab
Yes
Jira Align
Yes
Redmine
Yes
Pricing Details
No price information available.
Free Trial
No
Free Version
Yes
Pricing Details
€1300 per year
See: 'How to buy' on our homepage for the full offer
Free Trial
Yes
Free Version
No
Deployment
Web-Based
No
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
Yes
Mac
No
Linux
No
Chromebook
No
Deployment
Web-Based
Yes
On-Premises
Yes
iPhone App
No
iPad App
No
Android App
No
Windows
Yes
Mac
No
Linux
No
Chromebook
No
Customer Support
Business Hours
Yes
Live Rep (24/7)
No
Online Support
No
Customer Support
Business Hours
Yes
Live Rep (24/7)
No
Online Support
Yes
Types of Training
Training Docs
No
Webinars
Yes
Live Training (Online)
No
In Person
No
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
Yes
In Person
Yes
Vendor Details
Company Name
NSE Technology
Founded
2011
Country
South Korea
Website
www.silkroadalm.com/main.do
Vendor Details
Company Name
Aligned AG
Founded
2007
Country
Switzerland
Website
www.aligned.ch/
Product Features
Application Lifecycle Management
Administrator Level Control
No
Defect Tracking
Yes
Iteration Planning
No
Project Management
Yes
Release Management
Yes
Requirements Review
Yes
Task Management
Yes
Test Case Tracking
Yes
User Level Management
Yes
Version Control
Yes
Product Lifecycle Management
Change Management
No
Compliance Management
No
Cost Tracking
No
Design Management
No
Document Management
No
Product Data Management
No
Project Management
No
Requirements Management
No
Supplier Management
No
Requirements Management
Automated Functional Sizing
No
Automated Requirements QA
No
Automated Test Generation
No
Automated Use Case Modeling
No
Change Management
Yes
Collaboration
No
History Tracking
No
Prioritization
No
Reporting
Yes
Status Reporting
No
Status Tracking
Yes
Summary Reports
No
Task Management
Yes
To-Do List
No
Traceability
No
User Defined Attributes
No
Risk Management
Alerts/Notifications
No
Auditing
No
Business Process Control
No
Compliance Management
No
Corrective Actions (CAPA)
No
Dashboard
No
Exceptions Management
No
IT Risk Management
No
Internal Controls Management
No
Legal Risk Management
No
Mobile Access
No
Operational Risk Management
No
Predictive Analytics
No
Reputation Risk Management
No
Response Management
No
Risk Assessment
No
Workflow Management
Access Controls/Permissions
Yes
Approval Process Control
No
Business Process Automation
Yes
Calendar Management
Yes
Compliance Tracking
Yes
Configurable Workflow
No
Customizable Dashboard
No
Document Management
No
Forms Management
No
Graphical Workflow Editor
No
Mobile Access
Yes
No-Code
No
Task Management
Yes
Third Party Integrations
Yes
Workflow Configuration
Yes
Product Features
Application Lifecycle Management
Administrator Level Control
Yes
Defect Tracking
Yes
Iteration Planning
No
Project Management
No
Release Management
Yes
Requirements Review
Yes
Task Management
Yes
Test Case Tracking
Yes
User Level Management
Yes
Version Control
Yes
Requirements Management
Automated Functional Sizing
No
Automated Requirements QA
Yes
Automated Test Generation
Yes
Automated Use Case Modeling
No
Change Management
Yes
Collaboration
Yes
History Tracking
Yes
Prioritization
Yes
Reporting
Yes
Status Reporting
Yes
Status Tracking
Yes
Summary Reports
Yes
Task Management
Yes
To-Do List
Yes
Traceability
Yes
User Defined Attributes
Yes