Average Ratings 0 Ratings
Average Ratings 0 Ratings
Description
Ennov Regulatory Suite is a world-class solution for regulatory content and information management. It is a unified, centralized and end-to-end solution that supports the regulatory information workflow, from the earliest stages through market authorization. This is a common principle that companies who strive to achieve regulatory operational excellence share. This is because they know that such a solution will allow them to drive harmonization and promote standardization, improve collaboration and ensure compliance, eliminate waste and reduce costs, accelerate product releases, and allow them operate and compete in global markets more effectively. Ennov Doc, Ennov Dossier, and Ennov Process combine to provide support for the entire regulatory product cycle, from early planning of registration targets to product retirement. The Ennov Regulatory Suite is a valuable tool for planning regulatory activity.
Description
Innovatum provides enterprise labeling and regulatory data management software for manufacturers operating in regulated industries. Its RONOVA platform centralizes label design, product master data, artwork management, regulatory information, and production printing. The software enables organizations to create reusable label templates and distribute approved versions across multiple manufacturing facilities. Change management tools record modifications to label content, associated product information, translations, and approval decisions. Electronic signatures, role-based permissions, and audit trails support compliance with FDA 21 CFR Part 11 and other regulatory requirements. Destination labeling automatically applies appropriate languages, symbols, identifiers, and regulatory content based on the intended market. The platform also supports unique device identification, product serialization, electronic instructions for use, and traceability across manufacturing operations. Integration capabilities connect labeling workflows with SAP, Oracle, and other enterprise resource planning and manufacturing execution systems. Innovatum offers hosted and private cloud deployment options, implementation services, validation assistance, and migration support for organizations transitioning from its earlier ROBAR platform or other labeling systems.
API Access
Has API
No
API Access
Has API
No
Pricing Details
No price information available.
Free Trial
No
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
No
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)
Yes
Online Support
No
Customer Support
Business Hours
Yes
Live Rep (24/7)
Yes
Online Support
Yes
Types of Training
Training Docs
No
Webinars
No
Live Training (Online)
Yes
In Person
Yes
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
Yes
In Person
No
Vendor Details
Company Name
Ennov
Founded
1999
Country
France
Website
en.ennov.com
Vendor Details
Company Name
Innovatum
Founded
1993
Country
United States
Website
www.innovatum.com
Product Features
Compliance
Archiving & Retention
Yes
Artificial Intelligence (AI)
No
Audit Management
Yes
Compliance Tracking
Yes
Controls Testing
No
Environmental Compliance
No
FDA Compliance
Yes
HIPAA Compliance
No
ISO Compliance
Yes
Incident Management
Yes
OSHA Compliance
No
Risk Management
Yes
Sarbanes-Oxley Compliance
No
Surveys & Feedback
No
Version Control
Yes
Workflow / Process Automation
Yes
Product Features
Label Printing
Automation
No
Barcode Support
No
Categorization
No
Design Tools
No
Hardware Integration
No
Multi-Language Support
No
Product Data Integration
No
Regulatory Compliance
No
Templates
No