Average Ratings 0 Ratings
Average Ratings 0 Ratings
Description
In light of the constantly evolving national regulations and the intricate nature of preparing for regulatory submissions, organizations within the healthcare and life sciences sectors are increasingly focused on adopting smarter methodologies and intelligent systems to enhance efficiency, reduce costs, and shorten submission timelines. To tackle these challenges, RIMTrack emerges as a cutting-edge regulatory information management system that leverages cloud-ready artificial intelligence. Built from the ground up, its primary goal is to assist organizations in achieving precise and effective submission preparations while streamlining the various regulatory processes involved in tracking, licensing, approvals, regulatory and competitive intelligence, clinical trials, and comprehensive reporting across international stakeholders. By integrating seamlessly with existing Regulatory Information Management systems, RIMTrack facilitates a thorough end-to-end management of the entire regulatory lifecycle, ultimately empowering organizations to navigate the complexities of compliance with greater ease and accuracy. Such advancements not only improve operational efficiency but also position organizations to adapt more readily to future regulatory changes.
Description
Tailored specifically for the life sciences sector, eCADinfo is an engineering data management system that adheres to 21 CFR Part 11 regulations, aimed at enhancing compliance, productivity, and efficiency while simultaneously lowering costs in environments governed by the FDA. This system is capable of storing engineering data across diverse formats, which encompass engineering drawings, equipment or system specification databases, links to supplier websites, spreadsheets with device parameter details, as well as procedures, manuals, and shop sketches. eCADinfo enables users to organize this information into a structured hierarchy that aligns seamlessly with their existing business workflows. With its intuitive graphical user interface, users can quickly access a wealth of information, facilitating easier system maintenance and control. Key features of the engineering data management system include version control, collaboration tools, change management capabilities, standardization processes, and a compliant Excel spreadsheet environment that meets 21 CFR Part 11 standards. By streamlining data organization and management, eCADinfo ultimately supports the operational goals of businesses within regulated industries.
API Access
Has API
API Access
Has API
Integrations
Microsoft 365
Microsoft Azure
Microsoft Dynamics 365
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
WinWire Technologies
Country
United States
Website
www.winwire.com/regulatory-information-management/
Vendor Details
Company Name
CIMINFO Software
Founded
2017
Country
United States
Website
part11solutions.com/ecadinfo/
Product Features
Product Features
Data Management
Customer Data
Data Analysis
Data Capture
Data Integration
Data Migration
Data Quality Control
Data Security
Information Governance
Master Data Management
Match & Merge