Average Ratings 0 Ratings
Average Ratings 0 Ratings
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.
Description
Fabasoft Xpublisher is one of the leading publishing system providers in the German-speaking region and is part of Fabasoft's intelligent, cloud-native ecosystem, Fabasphere.
Xpublisher enables publishers, media companies and public research institutions, as well as associations and other organisations, to create, manage and publish their content across all channels. This includes planning and producing structured, media-neutral content, managing editorial coordination processes and automating print production, as well as distributing content efficiently across all channels - all in compliance with the highest European data protection standards.
The software is powered by the artificial intelligence technology of Fabasoft's partner company, Mindbreeze. The AI can generate teasers, translations and high-quality editorial content, as well as improving content reusability through automated tagging.
API Access
Has API
API Access
Has API
Integrations
Adobe InDesign
Adobe Stock
CMIS
ImageMagick
Microsoft Office 2021
Xeditor
Integrations
Adobe InDesign
Adobe Stock
CMIS
ImageMagick
Microsoft Office 2021
Xeditor
Pricing Details
No price information available.
Free Trial
Free Version
Pricing Details
No price information available.
Free Trial
Free Version
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Vendor Details
Company Name
Sierra Labs
Country
United States
Website
www.sierralabs.com/quality-management/
Vendor Details
Company Name
Fabasoft Xpublisher
Founded
2009
Country
Germany
Website
www.fabasoft.com/de/produkte/xpublisher
Product 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
Product Features
Content Management
Audio Content
Customizable Templates
Document Indexing
E-forms
Full Text Search
Image Editor
SEO Management
Text Editor
Version Control
Video Content
Website Management
Desktop Publishing
For Newspapers / Magazines
For Printing
For eBooks
HTML Import / Export
Handles Database Formats
Image Editing
Multiple Editing Layers
Object Snapping / Grouping
PDF Export / Import
Templates
Digital Asset Management
Asset Categorization
Asset Library
Asset Sharing
Brand Control
Customizable Branding
File Conversion
Metadata Management
Mobile App
Reporting/Analytics
Search Within Document
Search/Filter
Version Control
Watermarking
Workflow Management
Document Collaboration
Access Control / Permissions
Autosave
Chat / Messaging
Cloud Storage
Comments / Annotations
Edit / Change Tracking
Electronic Signature
Multiple File Formats
Pre-made Templates
Search
User Tagging
Version Control
Workflow / Approval Process
Document Control
Archiving & Retention
Automated Routing
Change Management
Compliance Management
Electronic Signature
Escalation Management
Periodic Review
Version Control
Document Generation
Batch Processing
Collaboration
Digital Signature
Interaction Tracking
Multiple Output Formats
Templates
Document Management
Access Controls
Archiving & Retention
Collaboration Tools
Compliance Tracking
Document Archiving
Document Assembly
Document Capture
Document Conversion
Document Delivery
Document Indexing
Document Retention
Electronic Signature
Email Management
File Recovery
File Type Conversion
Forms Management
Full Text Search
Offline Access
Optical Character Recognition
Print Management
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
Enterprise Content Management (ECM)
Archiving & Retention
Collaboration Tools
Content Lifecycle Management
Digital Asset Management
Document Management
Electronic Signature
Information Governance
Mobile Access
Search
Version Control
Workflow Management
Publishing and Subscriptions
Advertising Management
Books
Campaign Management
Catalogs
Circulation Management
Content Management
Layout & Design
Magazines
Newsletters
Newspapers
Software Documentation
Access Roles / User Permissions
Automatic Documentation Generation
Collaboration Tools
Docs Web Hosting
Feedback Capture
Markdown Support
Multiple Formats Support
Multiple Versions Support
Version Control
WYSIWIG Editor
Webhooks
reStructured Text Support