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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 ComplianceAuthor?

Glemser is dedicated to providing IT solutions specifically designed for regulated industries, with a strong emphasis on global life sciences and improving patient outcomes. Their innovative platform, ComplianceAuthor, simplifies the complexities associated with managing international product labeling for life science companies, making compliance with IDMP both cost-effective and less risky. The ComplianceAuthor for Global Labeling tool equips regulatory professionals with the ability to efficiently scale and optimize global labeling processes by utilizing cutting-edge technologies such as artificial intelligence, structured content, and natural language generation. By harnessing the power of AI and machine learning, the platform adeptly identifies, indexes, and extracts essential information, thereby offering insights into the best possible actions to take. The introduction of innovative workflow overlays streamlines standardized processes, ensuring that essential components remain compliant and well-governed. Furthermore, the incorporation of natural language generation enhances operational efficiencies and enables smart automation, giving organizations the tools they need to boost their overall productivity. This holistic strategy not only simplifies compliance initiatives but also creates a more flexible and responsive environment for companies in the life sciences sector, ultimately leading to better patient outcomes and industry advancements.

Media

Media

Integrations Supported

Additional information not provided

Integrations Supported

Additional information not provided

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.

Pricing Information

Pricing not provided

Supported Platforms

SaaS

Supported Platforms

SaaS

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub

Company Facts

Organization Name

Innovatum

Date Founded

1993

Company Location

United States

Company Website

www.innovatum.com

Company Facts

Organization Name

Glemser Technologies

Date Founded

1987

Company Location

United States

Company Website

glemser.com

Categories and Features

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

Artificial Intelligence (AI)

Life Sciences

Not specified

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