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Average Ratings 0 Ratings

Total
ease
features
design
support

No User Reviews. Be the first to provide a review:

Write a Review

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 No 

API Access

Has API No 

Screenshots View All

Screenshots View All

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 Yes 
Live Rep (24/7) No 
Online Support Yes 

Customer Support

Business Hours No 
Live Rep (24/7) No 
Online Support Yes 

Types of Training

Training Docs Yes 
Webinars No 
Live Training (Online) No 
In Person No 

Types of Training

Training Docs Yes 
Webinars No 
Live Training (Online) Yes 
In Person No 

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 No 
CAPA Planning No 
Change Management No 
Complaint Management No 
Incident Management No 
Nonconformance Tracking No 
Quality Control No 
Risk Management No 
Root Cause Analysis No 
Training Management No 

Product Features

CAPA

Audit Management No 
CAPA Planning No 
Change Management No 
Complaint Management No 
Incident Management No 
Nonconformance Tracking No 
Quality Control No 
Risk Management No 
Root Cause Analysis No 
Training Management No 

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