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Ratings and Reviews 0 Ratings
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What is Innovatum RONOVA?
Innovatum develops enterprise labeling and regulatory data management software designed for manufacturers that require controlled, validated labeling processes. Its primary platform, RONOVA, provides an integrated environment for managing label design, artwork, regulatory information, approval workflows, and production printing. The software centralizes product and regulatory attributes so approved information can be used consistently across labels, packaging, and electronic instructions for use. Label management capabilities include reusable templates, version control, electronic approvals, and centralized distribution across manufacturing facilities. Change management functionality records the reasons for modifications and links related changes to product records, artwork, translations, and label templates. RONOVA maintains timestamped audit trails and electronic signatures designed to support FDA 21 CFR Part 11 requirements and regulatory inspections. Destination labeling tools automatically apply language requirements, regulatory symbols, and product identifiers according to the country or market where products will be distributed. The platform supports unique device identification, serialization, electronic labeling, and traceability from manufacturing materials through finished products. Its regulatory capabilities address requirements associated with FDA, EU MDR, EU IVDR, NMPA, ANVISA, and other industry-specific labeling standards. Integration with SAP, Oracle, and compatible ERP and manufacturing execution systems enables product and order information to flow into labeling workflows without repeated manual entry. Innovatum provides hosted and private cloud deployment, configurable browser-based printing workflows, validation documentation, implementation assistance, and supported migration from ROBAR and other enterprise labeling solutions.
What is Ennov Regulatory Suite?
The Ennov Regulatory Suite stands out as a premier solution for managing regulatory content and information. This comprehensive, centralized platform facilitates the entire regulatory information workflow, spanning from initial stages to market authorization. Companies aiming for excellence in regulatory operations commonly adopt this approach because it fosters harmonization and promotes standardization, enhances collaboration while ensuring compliance, reduces waste and costs, accelerates time-to-market, and enables them to effectively compete in the global arena. The suite includes Ennov Doc, Ennov Dossier, and Ennov Process, which collectively support the complete regulatory product lifecycle, from the early phases of setting registration goals to the eventual retirement of products. By utilizing the Ennov Regulatory Suite, organizations can strategically plan their regulatory activities and streamline their processes efficiently. This makes it an indispensable asset for companies navigating the complexities of regulatory compliance.
Integrations Supported
API Availability
Has API
API Availability
Pricing Information
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.
â–Ž
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.
â–Ž
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.
Pricing Information
Pricing not provided
Supported Platforms
SaaS
Supported Platforms
SaaS
Windows
Customer Service / Support
Standard Support
24 Hour Support
Web-Based Support
Customer Service / Support
Standard Support
24 Hour Support
Training Options
Documentation Hub
Webinars
Online Training
On-Site Training
Training Options
Online Training
On-Site Training
Company Facts
Organization Name
Innovatum
Date Founded
1993
Company Location
United States
Company Website
www.innovatum.com
Company Facts
Organization Name
Ennov
Date Founded
1999
Company Location
France
Company Website
en.ennov.com
Categories and Features
Label and Artwork Management
Not specified
Label Design
Not specified
Label Printing
Automation
Barcode Support
Categorization
Design Tools
Hardware Integration
Multi-Language Support
Product Data Integration
Regulatory Compliance
Templates
Life Sciences
Not specified
Categories and Features
Compliance
Archiving & Retention
Audit Management
Compliance Tracking
FDA Compliance
ISO Compliance
Incident Management
Risk Management
Version Control
Workflow / Process Automation
Life Sciences
Not specified