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What is Nimonik?

Nimonik grants users access to standards from over 40 different standards development organizations, including prominent names like ISO, IEC, API, IEEE, and ASTM. Additionally, Nimonik provides insights into laws and regulations from more than 500 jurisdictions worldwide. This wealth of data is seamlessly integrated into Nimonik's workflow management tools, empowering companies to effectively oversee their compliance efforts and generate reports as necessary. The software focuses on global standards and regulatory compliance, facilitating organizations in pinpointing and extracting requirements from various regulatory documents, contracts, standards, and permits. Furthermore, Nimonik features a Compliance Management System (CMS) along with audit software that serves as a centralized hub for managing compliance responsibilities and performing audits efficiently. Alongside these tools, Nimonik offers a newsletter and library service that keeps businesses up-to-date with the latest regulatory trends and changes, ensuring they remain informed and compliant with evolving requirements. This comprehensive approach to compliance equips organizations with the necessary resources to navigate the complexities of regulatory environments effectively.

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.

Media

Media

Integrations Supported

Additional information not provided

Integrations Supported

Additional information not provided

API Availability

Has API

API Availability

Has API

Pricing Information

$500/year
Free Trial Offered?

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.

Supported Platforms

SaaS
Android
iPhone
iPad

Supported Platforms

SaaS

Customer Service / Support

Standard Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

Nimonik

Date Founded

2008

Company Location

Canada

Company Website

www.nimonik.com

Company Facts

Organization Name

Innovatum

Date Founded

1993

Company Location

United States

Company Website

www.innovatum.com

Categories and Features

EHS Management

Audit Management
Corrective / Preventive Actions
Environmental Management
Environmental Risk Assessment
Industrial Safety Management
Occupational Health Management
Safety Risk Assessment
Waste Management

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

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