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Average Ratings 0 Ratings

Total
ease
features
design
support

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Write a Review

Description

Sarjen's global dossier publishing software serves as a platform aimed at streamlining and automating the oversight and submission of regulatory dossiers. By enhancing the regulatory submission process through the automation of workflows tailored to specific regions and products, it significantly boosts consistency, efficiency, and precision. This automation not only expedites the creation, validation, and submission of dossiers but also minimizes the likelihood of manual errors and compliance-related issues. Designed to enhance operational efficiency, the solution ensures data consistency and that documentation remains ready for audits. Consequently, it saves valuable time while enabling quicker regulatory approvals, ultimately assisting in meeting diverse global compliance standards. Additionally, the platform's user-friendly interface empowers teams to manage submissions more effectively, leading to improved collaboration and faster turnaround times.

Description

ViSU™ is an innovative cloud-based platform for End-to-End Regulatory Information Management (RIM) tailored for the medical device sector, allowing users worldwide to efficiently access and oversee essential Regulatory Data, including Product Master details, Registrations, and Tracking. This comprehensive tool also facilitates the management of Dossiers and Technical Files through submission planning, development, and lifecycle management, while streamlining communication with Health Authorities and Notified Bodies, tracking obligations, managing Unique Device Identification (UDI), electronic Instructions for Use (eIFU), maintaining a Regulatory Requirements Database, and controlling changes. By adopting ViSU, organizations can fully harness the power of digital transformation in regulatory processes, achieving improved connectivity, enhanced traceability, and significant automation. Ultimately, ViSU contributes to heightened regulatory management efficiency, reduced compliance risks, and lowered operational costs, making it an indispensable asset for the industry. Moreover, its user-friendly interface ensures that teams can navigate the complexities of regulatory requirements with ease.

API Access

Has API

API Access

Has API

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Screenshots View All

Integrations

No details available.

Integrations

No details available.

Pricing Details

$200
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

Sarjen Systems

Founded

1998

Country

India

Website

www.sarjen.com

Vendor Details

Company Name

DDi

Founded

1997

Country

United States

Website

www.ddismart.com

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