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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

Kalypso offers a budget-friendly solution for life sciences organizations looking to implement a Regulatory Information Management (RIM) system, known as Accel for RIM. This platform facilitates an integrated approach to effectively oversee and monitor product registrations while enhancing the accuracy of submissions and managing global Unique Device Identification (UDI) information, thereby streamlining product distribution. It also merges compliance and quality data from multiple enterprise systems into a comprehensive source of truth for product registrations and tracking, which expedites regulatory submissions. Utilizing modern APIs, it aggregates product data along with necessary regulatory documentation and submission packages. The system is pre-configured for swift deployment and is built on a validated software framework, grounded in the best practices and successful implementations within the industry. By adopting this solution, companies can expect not only efficiency but also a significant reduction in time spent on regulatory tasks.

API Access

Has API

API Access

Has API

Screenshots View All

Screenshots View All

Integrations

No details available.

Integrations

No details available.

Pricing Details

No price information available.
Free Trial
Free Version

Pricing Details

No price information available.
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

Kalypso

Founded

2004

Country

United States

Website

kalypso.com/industries/life-sciences/digital-regulatory-information-management/

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

Alternatives

Alternatives

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