aligned elements

aligned elements

Aligned AG
+
+

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About

QVscribe, QRA's flagship product, unifies stakeholders by ensuring clear, concise artifacts. It automatically evaluates requirements, identifies risks, and guides engineers to address them. QVscribe simplifies artifact management by eliminating errors and verifying compliance with quality and industry standards. QVscribe Features: Glossary Integration: QVscribe now adds a fourth dimension by ensuring consistency across teams using different authoring tools. Term definitions appear alongside Quality Alerts, Warnings, and EARS Conformance checks within the project context. Customizable Configurations: Tailor QVscribe to meet specific verification needs for requirements, including business and system documents. This flexibility helps identify issues early before estimates or development progress. Integrated Guidance: QVscribe offers real-time recommendations during the editing process, helping authors effortlessly correct problem requirements and improve their quality.

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 Not Supported
iPhone Not Supported
iPad Not Supported
Android Not 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

Organizations interested in a tool that simplifies requirements management by eliminating errors and ensuring adherence to quality and industry standards

Audience

Medical Device Manufacturers looking for a design control management solution

Support

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

Support

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

API

Offers API Supported

API

Offers API Supported

Screenshots and Videos

Screenshots and Videos

Pricing

No information available.
Free Version Not 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 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

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

Training

Documentation Supported
Webinars Supported
Live Online Supported
In Person Not Supported

Training

Documentation Supported
Webinars Not Supported
Live Online Supported
In Person Supported

Company Information

QRA
Founded: 2012
Canada
qracorp.com

Company Information

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

Alternatives

Craftifact

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ReqView

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Kovair ALM

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Categories

Categories

Requirements Management Features

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

Artificial Intelligence Features

Chatbot Not Supported
For eCommerce Not Supported
For Healthcare Not Supported
For Sales Not Supported
Image Recognition Not Supported
Machine Learning Not Supported
Multi-Language Not Supported
Natural Language Processing Supported
Predictive Analytics Not Supported
Process/Workflow Automation Supported
Rules-Based Automation Supported
Virtual Personal Assistant (VPA) Not Supported

Compliance Features

Archiving & Retention Not Supported
Artificial Intelligence (AI) Supported
Audit Management Not Supported
Compliance Tracking Supported
Controls Testing Not Supported
Environmental Compliance Not Supported
FDA Compliance Not Supported
HIPAA Compliance Not Supported
Incident Management Not Supported
ISO Compliance Not Supported
OSHA Compliance Not Supported
Risk Management Not Supported
Sarbanes-Oxley Compliance Not Supported
Surveys & Feedback Not Supported
Version Control Not Supported
Workflow / Process Automation Not Supported

Data Quality Features

Address Validation Not Supported
Data Deduplication Not Supported
Data Discovery Supported
Data Profililng Not Supported
Master Data Management Not Supported
Match & Merge Not Supported
Metadata Management Not Supported

Natural Language Processing Features

Co-Reference Resolution Not Supported
In-Database Text Analytics Supported
Named Entity Recognition Not Supported
Natural Language Generation (NLG) Supported
Open Source Integrations Not Supported
Parsing Not Supported
Part-of-Speech Tagging Supported
Sentence Segmentation Not Supported
Stemming/Lemmatization Not Supported
Tokenization Not Supported

Quality Management Features

Audit Management Not Supported
Complaint Management Not Supported
Compliance Management Not Supported
Corrective and Preventive Actions (CAPA) Supported
Defect Tracking Not Supported
Document Control Supported
Equipment Management Not Supported
ISO Standards Management Not Supported
Maintenance Management Not Supported
Risk Management Not Supported
Supplier Quality Control Not Supported
Training Management Not 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

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

Integrations

Apache Subversion Not Supported
Azure DevOps Server Not Supported
GitHub Not Supported
GitLab Not Supported
IBM DOORS Next Supported
Jama Connect Supported
Jira Align Not Supported
Microsoft Excel Supported
Microsoft Word Supported
Modern Requirements4DevOps Supported
Polarion REQUIREMENTS Supported
Redmine Not Supported

Integrations

Apache Subversion Supported
Azure DevOps Server Supported
GitHub Supported
GitLab Supported
IBM DOORS Next Not Supported
Jama Connect Not Supported
Jira Align Supported
Microsoft Excel Not Supported
Microsoft Word Not Supported
Modern Requirements4DevOps Not Supported
Polarion REQUIREMENTS Not Supported
Redmine Supported
Claim QVscribe and update features and information
Claim QVscribe and update features and information
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Claim aligned elements and update features and information