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ease
features
design
support

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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

Screenshots View All

Screenshots View All

Integrations

Microsoft 365
Microsoft Azure
Microsoft Dynamics 365

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

Data Management

Customer Data
Data Analysis
Data Capture
Data Integration
Data Migration
Data Quality Control
Data Security
Information Governance
Master Data Management
Match & Merge

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