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Average Ratings 0 Ratings

Total
ease
features
design
support

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Write a Review

Description

Glemser specializes in delivering IT solutions tailored for regulated sectors, particularly focusing on global life sciences and enhancing patient outcomes. Their platform, ComplianceAuthor, simplifies the management of worldwide product labeling for life science firms, making IDMP more affordable while minimizing compliance risks. The ComplianceAuthor for Global Labeling tool empowers regulatory professionals in the life sciences sector to efficiently manage, scale, and optimize global product labeling and compliance using advanced technologies like artificial intelligence, structured content, and natural language generation. By leveraging artificial intelligence and machine learning, it can effectively locate, index, and extract vital information needed to suggest the most appropriate actions. The innovative workflow overlays introduced by the platform facilitate standardized processes, resulting in components that maintain compliance and control. Additionally, natural language generation supports the adoption of operational efficiencies and smarter automation, allowing organizations to enhance their overall productivity. This comprehensive approach not only streamlines compliance efforts but also fosters a more agile environment for life science companies.

Description

Innovatum provides enterprise labeling and regulatory data management software for manufacturers operating in regulated industries. Its RONOVA platform centralizes label design, product master data, artwork management, regulatory information, and production printing. The software enables organizations to create reusable label templates and distribute approved versions across multiple manufacturing facilities. Change management tools record modifications to label content, associated product information, translations, and approval decisions. Electronic signatures, role-based permissions, and audit trails support compliance with FDA 21 CFR Part 11 and other regulatory requirements. Destination labeling automatically applies appropriate languages, symbols, identifiers, and regulatory content based on the intended market. The platform also supports unique device identification, product serialization, electronic instructions for use, and traceability across manufacturing operations. Integration capabilities connect labeling workflows with SAP, Oracle, and other enterprise resource planning and manufacturing execution systems. Innovatum offers hosted and private cloud deployment options, implementation services, validation assistance, and migration support for organizations transitioning from its earlier ROBAR platform or other labeling systems.

API Access

Has API No 

API Access

Has API No 

Screenshots View All

Screenshots View All

Integrations

Adobe Creative Cloud No 
HL7 FHIR No 

Integrations

Adobe Creative Cloud Yes 
HL7 FHIR Yes 

Pricing Details

No price information available.
Free Trial No 
Free Version No 

Pricing Details

No price information available.
Free Trial No 
Free Version No 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App No 
iPad App No 
Android App No 
Windows No 
Mac No 
Linux No 
Chromebook No 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App No 
iPad App No 
Android App No 
Windows No 
Mac No 
Linux No 
Chromebook No 

Customer Support

Business Hours No 
Live Rep (24/7) No 
Online Support Yes 

Customer Support

Business Hours Yes 
Live Rep (24/7) Yes 
Online Support Yes 

Types of Training

Training Docs Yes 
Webinars No 
Live Training (Online) No 
In Person No 

Types of Training

Training Docs Yes 
Webinars No 
Live Training (Online) Yes 
In Person No 

Vendor Details

Company Name

Glemser Technologies

Founded

1987

Country

United States

Website

glemser.com

Vendor Details

Company Name

Innovatum

Founded

1993

Country

United States

Website

www.innovatum.com

Product Features

Compliance

Archiving & Retention No 
Artificial Intelligence (AI) Yes 
Audit Management No 
Compliance Tracking No 
Controls Testing No 
Environmental Compliance No 
FDA Compliance No 
HIPAA Compliance No 
ISO Compliance No 
Incident Management No 
OSHA Compliance No 
Risk Management No 
Sarbanes-Oxley Compliance No 
Surveys & Feedback No 
Version Control No 
Workflow / Process Automation No 

Product Features

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Alternatives

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