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Average Ratings 0 Ratings

Total
ease
features
design
support

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Write a Review

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 

Screenshots View All

Screenshots View All

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 

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