Average Ratings 0 Ratings
Average Ratings 0 Ratings
Description
The DXC RIM platform serves as a centralized hub for managing regulatory affairs content, data, and workflows, enabling teams to enhance their innovation efforts and shorten their time to market. Given the critical importance of regulatory affairs (RA) content, a cohesive platform is essential for efficiently managing both regulatory data and workflows. Teams require immediate and straightforward access to all pertinent information to function optimally. Additionally, a user-friendly, customizable interface is necessary to facilitate ease of navigation. To achieve success, having collaborative tools and adjustable reporting options is vital, yet outdated technology often hinders teams and prolongs processes. Compliance can be a daunting challenge, as collecting data and documenting procedures often demands considerable time and resources. The situation worsens when life sciences organizations are burdened with disjointed legacy systems that employ various technologies. In several instances, they may have to depend on spreadsheets for managing essential operational tasks. Therefore, to effectively bring products to market and oversee regulatory affairs, a robust, centralized solution is imperative for organizations. This comprehensive approach not only streamlines processes but also fosters an environment conducive to effective compliance and innovation.
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
No
API Access
Has API
No
Integrations
No details available.
Integrations
No details available.
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
Yes
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
No
Live Rep (24/7)
No
Online Support
Yes
Types of Training
Training Docs
Yes
Webinars
Yes
Live Training (Online)
No
In Person
No
Types of Training
Training Docs
No
Webinars
No
Live Training (Online)
No
In Person
No
Vendor Details
Company Name
DXC
Country
United States
Website
dxc.com/content/dam/dxc/projects/dxc-com/us/pdfs/services/applications/DG_8702a-23%20RIM%20Platform%20Offering%20Overview_v9.pdf
Vendor Details
Company Name
Kalypso
Founded
2004
Country
United States
Website
kalypso.com/industries/life-sciences/digital-regulatory-information-management/