Average Ratings 0 Ratings
Average Ratings 0 Ratings
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
Integrations
Adobe Creative Cloud
No
HL7 FHIR
No
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