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Average Ratings 0 Ratings

Total
ease
features
design
support

No User Reviews. Be the first to provide a review:

Write a Review

Description

Regulatory responsibilities rely heavily on expensive contributors within various regulatory materials. A cloud-based solution such as the Infosys regulated document management platform effectively addresses these challenges. It allows for externalization and collaborative authoring and editing of documents, thus simplifying governance and processes while implementing a consumption-based commercial model that includes support for audit trails. Additionally, it facilitates the creation of custom workflows and offers assistance with versioning, all backed by a proven solution that guarantees 99.95% uptime in production environments. This innovative system enables business users to swiftly locate documents from an extensive repository in just three to four seconds. Furthermore, users benefit from unlimited on-demand storage, enhancing their ability to manage data efficiently. The DMS leverages Google application programming interfaces (APIs) to minimize operational and maintenance expenses, ensuring that the company's overhead costs are confined to API usage and storage requirements. By adopting this advanced platform, organizations can significantly improve their regulatory compliance processes while also cutting costs.

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 No 

API Access

Has API No 

Screenshots View All

Screenshots View All

Integrations

Axe Credit Portal Yes 
Work-Relay Yes 

Integrations

Axe Credit Portal No 
Work-Relay 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 Yes 
Live Rep (24/7) No 
Online Support Yes 

Customer Support

Business Hours Yes 
Live Rep (24/7) Yes 
Online Support No 

Types of Training

Training Docs Yes 
Webinars No 
Live Training (Online) No 
In Person Yes 

Types of Training

Training Docs Yes 
Webinars No 
Live Training (Online) Yes 
In Person Yes 

Vendor Details

Company Name

Infosys

Founded

1981

Country

India

Website

www.infosys.com/industries/life-sciences/industry-offerings/regulated-document-management-platform.html

Vendor Details

Company Name

DDi

Founded

1997

Country

United States

Website

www.ddismart.com

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