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What is Loftware Cloud Clinical Trials?

Loftware Cloud Clinical Trials offers a powerful, cloud-based platform to manage the complex labeling and booklet requirements of clinical trials. Designed to ensure regulatory compliance, the software supports label creation, approval workflows, and distribution across global trial sites. Loftware Cloud simplifies the process with customizable templates, automatic barcode generation, and real-time tracking. By centralizing and automating clinical labeling, it enhances efficiency, reduces errors, and ensures that clinical trials meet the highest industry standards for compliance.

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

Oracle Cloud Infrastructure
SAP Cloud Platform
SAP Store

Integrations Supported

Adobe Creative Cloud
HL7 FHIR

API Availability

API Availability

Pricing Information

Pricing not provided

Pricing Information

Pricing not provided

Supported Platforms

SaaS
On-Prem

Supported Platforms

SaaS

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Webinars
On-Site Training

Training Options

Documentation Hub
Online Training

Company Facts

Organization Name

Loftware

Date Founded

1986

Company Location

United States

Company Website

www.loftware.com/products/labeling/loftware-cloud-clinical-trials

Company Facts

Organization Name

Innovatum

Date Founded

1993

Company Location

United States

Company Website

www.innovatum.com

Categories and Features

Categories and Features

Label Design

Not specified

Label Printing

Not specified

Life Sciences

Not specified

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