Average Ratings 0 Ratings
Average Ratings 0 Ratings
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.
Description
In light of the constantly evolving national regulations and the intricate nature of preparing for regulatory submissions, organizations within the healthcare and life sciences sectors are increasingly focused on adopting smarter methodologies and intelligent systems to enhance efficiency, reduce costs, and shorten submission timelines. To tackle these challenges, RIMTrack emerges as a cutting-edge regulatory information management system that leverages cloud-ready artificial intelligence. Built from the ground up, its primary goal is to assist organizations in achieving precise and effective submission preparations while streamlining the various regulatory processes involved in tracking, licensing, approvals, regulatory and competitive intelligence, clinical trials, and comprehensive reporting across international stakeholders. By integrating seamlessly with existing Regulatory Information Management systems, RIMTrack facilitates a thorough end-to-end management of the entire regulatory lifecycle, ultimately empowering organizations to navigate the complexities of compliance with greater ease and accuracy. Such advancements not only improve operational efficiency but also position organizations to adapt more readily to future regulatory changes.
API Access
Has API
Yes
API Access
Has API
No
Integrations
Microsoft 365
No
Microsoft Azure
No
Microsoft Dynamics 365
No
Integrations
Microsoft 365
Yes
Microsoft Azure
Yes
Microsoft Dynamics 365
Yes
Pricing Details
40,000 Foundation Tier
RONOVA is licensed as an annual SaaS subscription, priced in US dollars. Pricing is published openly. All figures are approximate starting points, not list prices.
Foundation, from approximately $40,000 per year: a single manufacturing site putting one validated system in place, with a core set of users and printers and the full control model (change management, audit trail, electronic signature).
Performance, from approximately $150,000 per year: several sites under one configuration, higher user and printer counts, and several markets with destination-driven content.
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Enterprise, quoted on request: a global network with many sites (including contract manufacturers), high printer counts and production volume, and US, EU, Brazil and China requirements in the same product record.
The final price depends on configuration: the number of sites, users, printers and regulatory markets in scope.
Scope is agreed before a quote is issued, so the figure in a proposal is a firm number rather than a range. Adding a site or a market changes the configuration and the subscription, but doesn't require a new deployment.
Foundation, from approximately $40,000 per year: a single manufacturing site putting one validated system in place, with a core set of users and printers and the full control model (change management, audit trail, electronic signature).
Performance, from approximately $150,000 per year: several sites under one configuration, higher user and printer counts, and several markets with destination-driven content.
▎
Enterprise, quoted on request: a global network with many sites (including contract manufacturers), high printer counts and production volume, and US, EU, Brazil and China requirements in the same product record.
The final price depends on configuration: the number of sites, users, printers and regulatory markets in scope.
Scope is agreed before a quote is issued, so the figure in a proposal is a firm number rather than a range. Adding a site or a market changes the configuration and the subscription, but doesn't require a new deployment.
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
No
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
Yes
Customer Support
Business Hours
Yes
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
Yes
Live Training (Online)
Yes
In Person
Yes
Vendor Details
Company Name
Innovatum
Founded
1993
Country
United States
Website
www.innovatum.com
Vendor Details
Company Name
WinWire Technologies
Country
United States
Website
www.winwire.com/regulatory-information-management/
Product Features
Label Printing
Automation
Yes
Barcode Support
Yes
Categorization
Yes
Design Tools
Yes
Hardware Integration
Yes
Multi-Language Support
Yes
Product Data Integration
Yes
Regulatory Compliance
Yes
Templates
Yes