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What is eCADinfo?

Designed explicitly for the life sciences domain, eCADinfo serves as an engineering data management solution that complies with 21 CFR Part 11 regulations, with the goal of improving compliance, productivity, and efficiency while also reducing costs in FDA-regulated settings. This system effectively accommodates a variety of engineering data formats, such as engineering drawings, databases for equipment or system specifications, links to supplier websites, spreadsheets detailing device parameters, as well as procedures, manuals, and shop sketches. eCADinfo empowers users to arrange this information into a structured hierarchy that integrates smoothly with their current business processes. Featuring an intuitive graphical user interface, it allows users to swiftly retrieve a vast array of information, which simplifies system maintenance and oversight. The engineering data management system boasts essential functionalities like version control, collaboration tools, change management capabilities, standardization processes, and a compliant Excel spreadsheet environment in line with 21 CFR Part 11 requirements. By optimizing data organization and management, eCADinfo plays a crucial role in helping businesses within regulated sectors achieve their operational objectives more effectively. Additionally, its versatile capabilities make it an invaluable asset for any organization striving for excellence in compliance and efficiency.

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

Integrations Supported

Adobe Creative Cloud
HL7 FHIR

API Availability

API Availability

Pricing Information

Pricing not provided

Pricing Information

Pricing not provided

Supported Platforms

SaaS

Supported Platforms

SaaS

Customer Service / Support

Standard Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training

Training Options

Documentation Hub
Online Training

Company Facts

Organization Name

CIMINFO Software

Date Founded

2017

Company Location

United States

Company Website

part11solutions.com/ecadinfo/

Company Facts

Organization Name

Innovatum

Date Founded

1993

Company Location

United States

Company Website

www.innovatum.com

Categories and Features

Data Management

Not specified

Life Sciences

Not specified

Categories and Features

Label Design

Not specified

Label Printing

Not specified

Life Sciences

Not specified

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