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features
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support

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Description

Designed for deployment in production settings, GlobalVision Desktop integrates our most advanced inspection capabilities into a single, powerful application, ensuring the precision of your files throughout the quality assurance process. You can analyze artwork files with meticulous pixel-level accuracy by seamlessly overlaying master files against samples to uncover any discrepancies. Barcodes can be evaluated and graded directly within the electronic file, eliminating the need for a physical scanner. Furthermore, you can inspect, verify, and translate Braille to guarantee its correctness and adherence to regulatory standards. Color accuracy can be validated anywhere on your artwork by measuring specific color space values using integrated Pantone libraries. The software also allows for direct side-by-side comparisons of two files to highlight any variations. In addition, you can review artwork files against their previous versions to confirm that updates are precise before moving forward with production, thus reinforcing the integrity of your quality control process. This comprehensive approach not only streamlines inspections but also enhances overall productivity.

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 No 

API Access

Has API No 

Screenshots View All

Screenshots View All

Integrations

Esko Software Yes 

Integrations

Esko Software 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 Yes 

Types of Training

Training Docs Yes 
Webinars No 
Live Training (Online) No 
In Person No 

Vendor Details

Company Name

GlobalVision

Founded

1990

Country

Canada

Website

globalvision.co/gvd/

Vendor Details

Company Name

Sierra Labs

Country

United States

Website

www.sierralabs.com/quality-management/

Product Features

Document Control

Archiving & Retention Yes 
Automated Routing No 
Change Management Yes 
Compliance Management Yes 
Electronic Signature Yes 
Escalation Management No 
Periodic Review No 
Version Control Yes 

Document Version Control

Access Controls/Permissions Yes 
Approval Process Control No 
Archiving & Retention No 
Audit Trail Yes 
Commenting / Notes No 
Document Check-in / Check-out Yes 
For Engineering Documents No 
Revision History No 
Version Comparison Yes 
Version Rollback No 

File and Document Comparison

Audio Comparison No 
Barcode Comparison No 
Braille Comparison No 
Code Comparison No 
Document Comparison No 
File Comparison No 
Image Comparison No 
PDF Comparison No 
Video Comparison No 

Proofreading

Contextual Speller No 
Dictionary / Thesaurus No 
Grammar Check No 
Plagiarism Detection No 
Punctuation Check No 
Reporting & Statistics Yes 
Spell Check Yes 
Style Check No 
Text Editor No 

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 

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