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What is Sierra QMS?

Workflows are meticulously designed to aid in the preparation of all essential elements needed for a 510(k) submission, while also guaranteeing adherence to the quality record standards outlined in 21 CFR Part 820 as you get ready to launch your device. These workflows are equipped with tools that simplify the creation of vital policies, procedures, and work instructions. In addition, you can keep track of non-conformances, deviations, and CAPAs with custom quality management reports. As your processes develop and improve, automatic training updates ensure your team remains informed. The system also streamlines validation testing for devices, applications, websites, and bespoke software tailored to meet your business requirements. This automation greatly diminishes the time and resources typically needed for comprehensive testing, reporting, and approval tasks. Moreover, you can consolidate all your policies, procedures, and artifacts into standardized documents, making them easily accessible for audit assessments. This solution not only simplifies compliance and validation procedures but also significantly boosts operational efficiency. By integrating such advanced workflows, organizations can enhance their overall productivity and adaptability in a competitive market.

What is QVscribe?

QRA’s innovative tools enhance the generation, assessment, and forecasting of engineering artifacts, enabling engineers to shift their focus from monotonous tasks to vital path development. Our offerings automate the generation of safe project artifacts designed for high-stakes engineering environments. Engineers frequently find themselves bogged down by the repetitive process of refining requirements, with the quality of these metrics differing significantly across various sectors. QVscribe, the flagship product of QRA, addresses this issue by automatically aggregating these metrics and integrating them into project documentation, thereby identifying potential risks, errors, and ambiguities. This streamlined process allows engineers to concentrate on more intricate challenges at hand. To make requirement authoring even easier, QRA has unveiled an innovative five-point scoring system that boosts engineers' confidence in their work. A perfect score indicates that the structure and phrasing are spot on, while lower scores provide actionable feedback for improvement. This functionality not only enhances the current requirements but also minimizes common mistakes and fosters the development of better authoring skills as time progresses. Furthermore, by leveraging these tools, teams can expect to see increased efficiency and improved project outcomes.

Media

Media

Integrations Supported

IBM DOORS Next
Jama Connect
Microsoft Excel
Microsoft Word
Modern Requirements4DevOps
Polarion REQUIREMENTS

Integrations Supported

IBM DOORS Next
Jama Connect
Microsoft Excel
Microsoft Word
Modern Requirements4DevOps
Polarion REQUIREMENTS

API Availability

Has API

API Availability

Has API

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

Sierra Labs

Company Location

United States

Company Website

www.sierralabs.com/quality-management/

Company Facts

Organization Name

QRA

Date Founded

2012

Company Location

Canada

Company Website

qracorp.com

Categories and Features

CAPA

Audit Management
CAPA Planning
Change Management
Complaint Management
Incident Management
Nonconformance Tracking
Quality Control
Risk Management
Root Cause Analysis
Training Management

Compliance

Archiving & Retention
Artificial Intelligence (AI)
Audit Management
Compliance Tracking
Controls Testing
Environmental Compliance
FDA Compliance
HIPAA Compliance
ISO Compliance
Incident Management
OSHA Compliance
Risk Management
Sarbanes-Oxley Compliance
Surveys & Feedback
Version Control
Workflow / Process Automation

Document Control

Archiving & Retention
Automated Routing
Change Management
Compliance Management
Electronic Signature
Escalation Management
Periodic Review
Version Control

Document Version Control

Access Controls/Permissions
Approval Process Control
Archiving & Retention
Audit Trail
Commenting / Notes
Document Check-in / Check-out
For Engineering Documents
Revision History
Version Comparison
Version Rollback

Quality Management

Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
ISO Standards Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management

Risk Management

Alerts/Notifications
Auditing
Business Process Control
Compliance Management
Corrective Actions (CAPA)
Dashboard
Exceptions Management
IT Risk Management
Internal Controls Management
Legal Risk Management
Mobile Access
Operational Risk Management
Predictive Analytics
Reputation Risk Management
Response Management
Risk Assessment

Categories and Features

Artificial Intelligence

Chatbot
For Healthcare
For Sales
For eCommerce
Image Recognition
Machine Learning
Multi-Language
Natural Language Processing
Predictive Analytics
Process/Workflow Automation
Rules-Based Automation
Virtual Personal Assistant (VPA)

Compliance

Archiving & Retention
Artificial Intelligence (AI)
Audit Management
Compliance Tracking
Controls Testing
Environmental Compliance
FDA Compliance
HIPAA Compliance
ISO Compliance
Incident Management
OSHA Compliance
Risk Management
Sarbanes-Oxley Compliance
Surveys & Feedback
Version Control
Workflow / Process Automation

Data Quality

Address Validation
Data Deduplication
Data Discovery
Data Profililng
Master Data Management
Match & Merge
Metadata Management

Natural Language Processing

Co-Reference Resolution
In-Database Text Analytics
Named Entity Recognition
Natural Language Generation (NLG)
Open Source Integrations
Parsing
Part-of-Speech Tagging
Sentence Segmentation
Stemming/Lemmatization
Tokenization

Quality Management

Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
ISO Standards Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management

Requirements Management

Automated Functional Sizing
Automated Requirements QA
Automated Test Generation
Automated Use Case Modeling
Change Management
Collaboration
History Tracking
Prioritization
Reporting
Status Reporting
Status Tracking
Summary Reports
Task Management
To-Do List
Traceability
User Defined Attributes

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