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Average Ratings 0 Ratings

Total 0 out of 5 stars
ease 0 out of 5 stars
features 0 out of 5 stars
design 0 out of 5 stars
support 0 out of 5 stars

No User Reviews. Be the first to provide a review:

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Description

QRA’s tools streamline engineering artifact generation, evaluation, and prediction, refocusing engineers from tedious work to critical path development. Our solutions automate the creation of risk-free project artifacts for high-stakes engineering. Engineers often spend excessive time on the mundane task of refining requirements, with quality metrics varying across industries. QVscribe, QRA's flagship product, streamlines this by automatically consolidating these metrics and applying them to your documentation, identifying risks, errors, and ambiguities. This efficiency allows engineers to focus on more complex challenges. To further simplify requirement authoring, QRA introduced a pioneering five-point scoring system that instills confidence in engineers. A perfect score confirms accurate structure and phrasing, while lower scores prompt corrective guidance. This feature not only refines current requirements but also reduces common errors and enhances authoring skills over time.

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 Yes 

API Access

Has API Yes 

Screenshots View All

Screenshots View All

Integrations

Apache Subversion No 
Azure DevOps Server No 
GitHub No 
GitLab No 
IBM DOORS Next Yes 
Jama Connect Yes 
Jira Align No 
Microsoft Excel Yes 
Microsoft Word Yes 
Modern Requirements4DevOps Yes 
Polarion REQUIREMENTS Yes 
Redmine No 

Integrations

Apache Subversion Yes 
Azure DevOps Server Yes 
GitHub Yes 
GitLab Yes 
IBM DOORS Next No 
Jama Connect No 
Jira Align Yes 
Microsoft Excel No 
Microsoft Word No 
Modern Requirements4DevOps No 
Polarion REQUIREMENTS No 
Redmine Yes 

Pricing Details

No price information available.
Free Trial Yes 
Free Version No 

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 Yes 
Mac Yes 
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 Yes 
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

QRA

Founded

2012

Country

Canada

Website

qracorp.com

Vendor Details

Company Name

Aligned AG

Founded

2007

Country

Switzerland

Website

www.aligned.ch/

Product Features

Artificial Intelligence

Chatbot No 
For Healthcare No 
For Sales No 
For eCommerce No 
Image Recognition No 
Machine Learning No 
Multi-Language No 
Natural Language Processing Yes 
Predictive Analytics No 
Process/Workflow Automation Yes 
Rules-Based Automation Yes 
Virtual Personal Assistant (VPA) No 

Compliance

Archiving & Retention No 
Artificial Intelligence (AI) Yes 
Audit Management No 
Compliance Tracking Yes 
Controls Testing No 
Environmental Compliance No 
FDA Compliance No 
HIPAA Compliance No 
ISO Compliance No 
Incident Management No 
OSHA Compliance No 
Risk Management No 
Sarbanes-Oxley Compliance No 
Surveys & Feedback No 
Version Control No 
Workflow / Process Automation No 

Data Quality

Address Validation No 
Data Deduplication No 
Data Discovery Yes 
Data Profililng No 
Master Data Management No 
Match & Merge No 
Metadata Management No 

Natural Language Processing

Co-Reference Resolution No 
In-Database Text Analytics Yes 
Named Entity Recognition No 
Natural Language Generation (NLG) Yes 
Open Source Integrations No 
Parsing No 
Part-of-Speech Tagging Yes 
Sentence Segmentation No 
Stemming/Lemmatization No 
Tokenization No 

Quality Management

Audit Management No 
Complaint Management No 
Compliance Management No 
Corrective and Preventive Actions (CAPA) Yes 
Defect Tracking No 
Document Control Yes 
Equipment Management No 
ISO Standards Management No 
Maintenance Management No 
Risk Management No 
Supplier Quality Control No 
Training Management No 

Requirements Management

Automated Functional Sizing No 
Automated Requirements QA Yes 
Automated Test Generation Yes 
Automated Use Case Modeling No 
Change Management No 
Collaboration Yes 
History Tracking Yes 
Prioritization Yes 
Reporting Yes 
Status Reporting Yes 
Status Tracking No 
Summary Reports Yes 
Task Management No 
To-Do List No 
Traceability Yes 
User Defined Attributes 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 

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