Average Ratings 0 Ratings
Average Ratings 0 Ratings
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
Workflows are specifically developed to assist you in preparing all necessary components for a 510(k) submission, while also ensuring compliance with the quality record requirements set forth in 21 CFR Part 820 as you prepare to market your device. These workflows come equipped with tools to facilitate the drafting of essential policies, procedures, and work instructions. Furthermore, you can monitor non-conformances, deviations, and CAPAs through tailored quality management reports. As your processes evolve and enhance, you can ensure your team receives automatic training updates. The system also automates validation testing for devices, applications, websites, and custom software tailored to your business needs. This automation significantly reduces the time and resources that would otherwise be consumed by extensive testing, reporting, and approval processes. Additionally, you can compile all your policies, procedures, and artifacts into standard documents, making them readily available for audit evaluations. Overall, this solution streamlines the compliance and validation processes, thereby enhancing operational efficiency.
API Access
Has API
Yes
API Access
Has API
No
Integrations
IBM DOORS Next
Yes
Jama Connect
Yes
Microsoft Excel
Yes
Microsoft Word
Yes
Modern Requirements4DevOps
Yes
Polarion REQUIREMENTS
Yes
Integrations
IBM DOORS Next
No
Jama Connect
No
Microsoft Excel
No
Microsoft Word
No
Modern Requirements4DevOps
No
Polarion REQUIREMENTS
No
Pricing Details
No price information available.
Free Trial
Yes
Free Version
No
Pricing Details
No price information available.
Free Trial
No
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
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
Customer Support
Business Hours
Yes
Live Rep (24/7)
No
Online Support
Yes
Customer Support
Business Hours
No
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)
No
In Person
No
Vendor Details
Company Name
QRA
Founded
2012
Country
Canada
Website
qracorp.com
Vendor Details
Company Name
Sierra Labs
Country
United States
Website
www.sierralabs.com/quality-management/
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
CAPA
Audit Management
Yes
CAPA Planning
No
Change Management
Yes
Complaint Management
Yes
Incident Management
Yes
Nonconformance Tracking
Yes
Quality Control
Yes
Risk Management
Yes
Root Cause Analysis
Yes
Training Management
Yes
Compliance
Archiving & Retention
Yes
Artificial Intelligence (AI)
No
Audit Management
Yes
Compliance Tracking
Yes
Controls Testing
No
Environmental Compliance
Yes
FDA Compliance
Yes
HIPAA Compliance
No
ISO Compliance
Yes
Incident Management
Yes
OSHA Compliance
Yes
Risk Management
No
Sarbanes-Oxley Compliance
Yes
Surveys & Feedback
Yes
Version Control
Yes
Workflow / Process Automation
Yes
Document Control
Archiving & Retention
Yes
Automated Routing
Yes
Change Management
Yes
Compliance Management
Yes
Electronic Signature
Yes
Escalation Management
No
Periodic Review
Yes
Version Control
Yes
Document Version Control
Access Controls/Permissions
Yes
Approval Process Control
Yes
Archiving & Retention
Yes
Audit Trail
Yes
Commenting / Notes
Yes
Document Check-in / Check-out
Yes
For Engineering Documents
Yes
Revision History
Yes
Version Comparison
Yes
Version Rollback
Yes
Quality Management
Audit Management
Yes
Complaint Management
Yes
Compliance Management
Yes
Corrective and Preventive Actions (CAPA)
Yes
Defect Tracking
Yes
Document Control
No
Equipment Management
Yes
ISO Standards Management
Yes
Maintenance Management
Yes
Risk Management
Yes
Supplier Quality Control
Yes
Training Management
Yes
Risk Management
Alerts/Notifications
Yes
Auditing
No
Business Process Control
Yes
Compliance Management
Yes
Corrective Actions (CAPA)
Yes
Dashboard
No
Exceptions Management
Yes
IT Risk Management
Yes
Internal Controls Management
Yes
Legal Risk Management
No
Mobile Access
Yes
Operational Risk Management
Yes
Predictive Analytics
Yes
Reputation Risk Management
No
Response Management
Yes
Risk Assessment
Yes