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ease
features
design
support

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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

API Access

Has API

Screenshots View All

Screenshots View All

No images available

Integrations

No details available.

Integrations

No details available.

Pricing Details

No price information available.
Free Trial
Free Version

Pricing Details

$300
Free Trial
Free Version

Deployment

Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook

Deployment

Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook

Customer Support

Business Hours
Live Rep (24/7)
Online Support

Customer Support

Business Hours
Live Rep (24/7)
Online Support

Types of Training

Training Docs
Webinars
Live Training (Online)
In Person

Types of Training

Training Docs
Webinars
Live Training (Online)
In Person

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
Artificial Intelligence (AI)
Audit Management
Compliance Tracking
Controls Testing
Environmental Compliance
FDA Compliance
HIPAA Compliance
ISO Compliance
Incident Management
OSHA Compliance
Risk Management
Sarbanes-Oxley Compliance
Surveys & Feedback
Version Control
Workflow / Process Automation

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Alternatives

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