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Average Ratings 0 Ratings
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.
Description
PhlexRIM is set to significantly enhance compliance by providing real-time access to global registration data in a highly efficient manner. The latest version, PhlexRIM 2.0, features a collection of pre-configured automation assistants, known as “bots,” along with built-in regulatory scenarios that adhere to industry best practices. With an easy-to-use drag-and-drop design interface, regulatory teams can streamline their business operations without needing programming skills or assistance from IT departments. Furthermore, it allows for effective management of the pharmaceutical product registration lifecycle. Users can access detailed status updates and take advantage of the alert management system integrated into all workflows. Reporting capabilities are also robust, enabling the use of standard reports or the creation of custom reports tailored to specific needs. Additionally, the platform facilitates the creation and assignment of regulatory tasks within various levels of the organization, including management, departments, headquarters, and affiliates, ensuring cohesive collaboration across teams.
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
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
No
Live Rep (24/7)
No
Online Support
Yes
Customer Support
Business Hours
Yes
Live Rep (24/7)
No
Online Support
Yes
Types of Training
Training Docs
No
Webinars
No
Live Training (Online)
No
In Person
No
Types of Training
Training Docs
Yes
Webinars
Yes
Live Training (Online)
Yes
In Person
No
Vendor Details
Company Name
Kalypso
Founded
2004
Country
United States
Website
kalypso.com/industries/life-sciences/digital-regulatory-information-management/
Vendor Details
Company Name
Phlexglobal
Founded
1997
Country
United Kingdom
Website
www.phlexglobal.com/phlexrim