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
ProcEdge Regulatory Information Management System (RIMS) provides companies with a powerful, centralized platform to manage complex regulatory requirements for their entire global product portfolio. Moving away from traditional Excel-based tracking, it offers a single source of truth that connects multiple departments, providing 360-degree visibility and real-time updates on product registration, license maintenance, and post-registration activities. The platform enables detailed planning and tracking of submission timelines tailored to country-specific regulations, helping users meet compliance standards and reduce costly errors. It features configurable data models, automated email notifications, and a robust workflow engine that streamlines query management and response tracking. ProcEdge RIMS complies with global standards like IDMP and regulatory frameworks including GxP, GDPR, and Part 11. By eliminating redundant systems and manual data entry, it significantly reduces operational expenses and accelerates health agency approvals. The system’s audit trails and electronic signature capabilities ensure data integrity and regulatory reliability. Overall, it empowers regulatory professionals to make faster, informed decisions and maintain product marketability efficiently.
API Access
Has API
No
API Access
Has API
No
Screenshots View All
No images available
Integrations
No details available.
Integrations
No details available.
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Pricing Details
$300
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
Yes
iPhone App
No
iPad App
No
Android App
No
Windows
Yes
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
Yes
Live Training (Online)
Yes
In Person
Yes
Vendor Details
Company Name
Glemser Technologies
Founded
1987
Country
United States
Website
glemser.com
Vendor Details
Company Name
Sarjen Systems Pvt Ltd
Founded
1998
Country
India
Website
rims.sarjen.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