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Average Ratings 0 Ratings
Description
Relyence® Failure Reporting, Analysis, and Corrective Action System software offers a comprehensive framework for effectively managing all your issues of concern. This versatile tool allows you to monitor various incidents such as customer complaints, field failures, safety issues, compliance matters, and audit findings, ensuring that your organization can respond promptly and effectively. Built with the understanding that each corrective action process is unique, Relyence FRACAS provides the flexibility needed to adapt to your specific requirements. When searching for FRACAS software, it's essential to find a solution that aligns with your needs rather than forcing you to conform to its limitations. Relyence FRACAS stands out as the ideal choice, allowing users to leverage built-in 8D, DMAIC, or PDCA templates, modify existing templates, or design new ones using its user-friendly customization options. This ensures that you have the tools necessary to streamline your corrective action process and improve overall operational efficiency.
Description
adWATCH - AE is a solution designed to aid pharmaceutical companies in handling and documenting adverse events that arise during clinical trials. It provides a quick and efficient way for reporters at clinics, hospitals, or investigative sites to create and oversee Adverse Event Reports (AERs), ensuring proper reporting to regulatory bodies and government organizations. An adverse effect refers to a harmful or undesirable reaction experienced by a patient due to medications or medical devices. The process of documenting adverse events necessitates thorough tracking of all medical complaint case details, which culminates in the creation of MedWatch reports, CIOMS reports, and other management documentation. With adWATCH - AE, researchers, physician investigators, Contract Research Organizations (CROs), clinical trial experts, and various health professionals can easily generate and submit AERs in compliance with FDA requirements, adhering to both MedWatch and CIOMS formats. This streamlined process not only enhances regulatory compliance but also improves patient safety oversight during clinical trials.
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
Relyence Corporation
Country
United States
Website
relyence.com/products/fracas/
Vendor Details
Company Name
Atlant Systems
Website
atlantsystems.com/atlant/solutions/atwatch-ae/
Product Features
CAPA
Audit Management
CAPA Planning
Change Management
Complaint Management
Incident Management
Nonconformance Tracking
Quality Control
Risk Management
Root Cause Analysis
Training Management
Product Features
CAPA
Audit Management
CAPA Planning
Change Management
Complaint Management
Incident Management
Nonconformance Tracking
Quality Control
Risk Management
Root Cause Analysis
Training Management