Visure Requirements

Visure Requirements

Visure Solutions, Inc.
aligned elements

aligned elements

Aligned AG
+
+

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About

Visure Solutions, Inc. is a leading provider of requirements management tool suites offering a comprehensive collaborative ALM Platform for system engineering industries. Visure’s value proposition is nothing less than the total innovative technology in key functions: standard compliance for safety-critical and business-critical systems. - Requirements and Traceability Management - Test Management - Bug & Issue Tracking - Risk Management - Collaboration Management - Centralized data base, Review/Approval process - Certification Management (Support of many Standard Templates ISO26262, IEC62304, IEC61508, CENELEC50128, DO178/C, FMEA, GAMP5, SPICE, CMMI, etc. + Tool Qualification Package) - Configuration Management, Baselining, History Tracking, Requirements Versioning - Dashboards + Report Customization - Integrated with DOORS, Jama, Siemens Polarion, PTC, Perforce, JIRA, Enterprise Architect, HP ALM, Microfocus ALM, PTC, TFS, Word, Excel, Test RT, RTRT, VectorCAST, LDRA, etc.

About

Aligned eQMS and Aligned Elements Design Control software are built specifically for medical device and IVD companies that need to meet global regulatory requirements without unnecessary complexity. The platform supports compliance with ISO 13485, FDA QSMR, EU MDR, and IVDR, and is trusted by experts that want full control over quality, design, and regulatory processes across the entire product lifecycle. Aligned products, designed for collaboration between quality, regulatory, R&D, and management teams, combines a complete electronic Quality Management System with deep Design Control functionality in one fully integrated environment. Design inputs, outputs, verification, validation, risk management, and change control are natively connected to the QMS, ensuring end to end traceability that stands up to audits and inspections.

Platforms Supported

Windows Supported
Mac Supported
Linux Not Supported
Cloud Supported
On-Premises Supported
iPhone Supported
iPad Supported
Android Supported
Chromebook Not Supported

Platforms Supported

Windows Supported
Mac Not Supported
Linux Not Supported
Cloud Supported
On-Premises Supported
iPhone Not Supported
iPad Not Supported
Android Not Supported
Chromebook Not Supported

Audience

System Engineers, Embedded Application Engineers, Software Developers, Project Managers, Quality Engineers, Testers, Business Analysts, etc.

Audience

Medical Device Manufacturers looking for a design control management solution

Support

Phone Support Supported
24/7 Live Support Supported
Online Supported

Support

Phone Support Supported
24/7 Live Support Not Supported
Online Supported

API

Offers API Not Supported

API

Offers API Supported

Screenshots and Videos

Screenshots and Videos

Pricing

3 licensing models:
- Perpetual and subscription
- Floating and named user licenses
- On-premise and cloud
Free Version Supported
Free Trial Supported

Pricing

€1300 per year
See: 'How to buy' on our homepage for the full offer
Free Version Not Supported
Free Trial Supported

Reviews/Ratings

Overall 5.0 / 5
ease 4.0 / 5
features 5.0 / 5
design 5.0 / 5
support 4.7 / 5

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software

Pros & Cons from Real Users

Pros

  • Great UI - It´s very powerful, but stil intuitive enough Built-in template for automotive - traceability matrix, specs, types, reports, etc. Price
  • - The traceability is built-in the process and the tool enforce and maintain the traceability - Nice reporting and dashboards
  • Fast and powerful document import from MS Word Very good MS Word document generation Excellent requirement management and traceability options Robust application Rich item descriptions Uses Oracle and SQLServer backends

Cons

  • Help files can improve Should have the interface and dictionary in more languagesWe´re happy we found this software. We managed to get started really quickly and get users on board into the project. There are many RM tools out there, but many of them will just not do the job for our sector.
  • Time zone, but now they just open another office in Europe
  • Old fashioned user interface Poor performance when managing more than 50,000 items

Training

Documentation Supported
Webinars Supported
Live Online Supported
In Person Supported

Training

Documentation Supported
Webinars Not Supported
Live Online Supported
In Person Supported

Company Information

Visure Solutions, Inc.
Founded: 2007
United States
visuresolutions.com

Company Information

Aligned AG
Founded: 2007
Switzerland
www.aligned.ch/

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Categories

Categories

Application Lifecycle Management Features

Administrator Level Control Supported
Defect Tracking Not Supported
Iteration Planning Not Supported
Project Management Supported
Release Management Supported
Requirements Review Supported
Task Management Supported
Test Case Tracking Supported
User Level Management Supported
Version Control Supported

Requirements Management Features

Automated Functional Sizing Not Supported
Automated Requirements QA Not Supported
Automated Test Generation Not Supported
Automated Use Case Modeling Not Supported
Change Management Supported
Collaboration Supported
History Tracking Supported
Prioritization Supported
Reporting Supported
Status Reporting Supported
Status Tracking Supported
Summary Reports Supported
Task Management Supported
To-Do List Supported
Traceability Supported
User Defined Attributes Supported

Bug Tracking Features

Backlog Management Not Supported
Filtering Supported
Issue Tracking Supported
Release Management Not Supported
Task Management Supported
Ticket Management Supported
Workflow Management Supported

Application Lifecycle Management Features

Administrator Level Control Supported
Defect Tracking Supported
Iteration Planning Not Supported
Project Management Not Supported
Release Management Supported
Requirements Review Supported
Task Management Supported
Test Case Tracking Supported
User Level Management Supported
Version Control Supported

Requirements Management Features

Automated Functional Sizing Not Supported
Automated Requirements QA Supported
Automated Test Generation Supported
Automated Use Case Modeling Not Supported
Change Management Supported
Collaboration Supported
History Tracking Supported
Prioritization Supported
Reporting Supported
Status Reporting Supported
Status Tracking Supported
Summary Reports Supported
Task Management Supported
To-Do List Supported
Traceability Supported
User Defined Attributes Supported

Integrations

Apache Subversion Not Supported
Azure DevOps Supported
Azure DevOps Server Not Supported
GitHub Not Supported
GitLab Not Supported
Jira Supported
Jira Align Not Supported
Jira Work Management Supported
Redmine Not Supported
VectorCAST Supported

Integrations

Apache Subversion Supported
Azure DevOps Not Supported
Azure DevOps Server Supported
GitHub Supported
GitLab Supported
Jira Not Supported
Jira Align Supported
Jira Work Management Not Supported
Redmine Supported
VectorCAST Not Supported
Claim Visure Requirements and update features and information
Claim Visure Requirements and update features and information
Claim aligned elements and update features and information
Claim aligned elements and update features and information