Average Ratings 0 Ratings
Average Ratings 0 Ratings
Description
Specifications serve to outline the project scope for teams in a consolidated manner, enabling a shared understanding among all members, including project managers, designers, solution architects, software developers, and quality analysts, regarding the solution being developed. This centralized approach fosters collaboration, allowing the team to collectively update and refine the project scope. By consolidating all designs in one location, you can provide additional insights into complex areas that may not be fully conveyed through visuals alone. Gaining a comprehensive view of your project's scope is essential for accurately estimating timelines and costs. This clarity eliminates uncertainty about feature functionalities, facilitating the creation of targeted tests that ensure the desired outcomes are achieved. Clearly articulating the requirements for your development team is crucial for smooth project execution. Ultimately, well-defined specifications empower teams to work more efficiently and effectively towards their project goals.
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
Yes
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
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
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
Yes
Customer Support
Business Hours
Yes
Live Rep (24/7)
No
Online Support
Yes
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
Yes
In Person
No
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
Yes
In Person
Yes
Vendor Details
Company Name
SPEQit
Founded
2014
Country
Canada
Website
www.speqit.com
Vendor Details
Company Name
Aligned AG
Founded
2007
Country
Switzerland
Website
www.aligned.ch/
Product Features
Requirements Management
Automated Functional Sizing
No
Automated Requirements QA
No
Automated Test Generation
No
Automated Use Case Modeling
No
Change Management
Yes
Collaboration
Yes
History Tracking
No
Prioritization
No
Reporting
Yes
Status Reporting
Yes
Status Tracking
Yes
Summary Reports
No
Task Management
Yes
To-Do List
No
Traceability
Yes
User Defined Attributes
No
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