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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 To achieve success, having collaborative tools and adjustable reporting options is vital, yet outdated technology often hinders teams and prolongs processes.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
Emergo by UL's Regulatory Affairs Management Suite (RAMS) is an all-encompassing software-as-a-service solution crafted to optimize regulatory and quality management processes for companies involved in medical devices and in vitro diagnostics. Drawing on extensive expertise in regulatory compliance, RAMS equips users with a range of tools to effectively navigate the intricate and ever-changing realm of global medical device regulations. Among its standout features is product classification, which assists users by guiding them through a structured series of inquiries to ascertain or confirm the classification of their devices. Additionally, the Smart Builder offers comprehensive step-by-step instructions and ready-made text to aid in the creation of precise regulatory documentation, thereby facilitating a smoother path to device registration and expedited market entry. Furthermore, the Registration Tracker serves to automate the oversight of international registrations and certifications, ensuring that organizations do not overlook renewals and consistently uphold compliance standards. This proactive approach not only enhances efficiency but also significantly reduces the risk of regulatory setbacks.
API Access
Has API
API Access
Has API
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
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
Emergo by UL
Country
United States
Website
www.emergobyul.com/software/regulatory-affairs-management-suite