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Ratings and Reviews 0 Ratings
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What is adWATCH?
adWATCH - AE serves as a comprehensive solution for pharmaceutical companies to effectively manage and document adverse events that may occur throughout clinical trials. It offers a rapid and streamlined method for individuals at clinics, hospitals, or research sites to generate and monitor Adverse Event Reports (AERs), ensuring that all necessary information is accurately relayed to regulatory authorities and governmental entities. An adverse event is defined as any harmful or negative reaction a patient experiences as a result of medications or medical devices. The meticulous documentation of these adverse events requires detailed tracking of all medical case specifics, which leads to the production of essential reports such as MedWatch and CIOMS. With the implementation of adWATCH - AE, researchers, physician investigators, Contract Research Organizations (CROs), and various healthcare professionals can efficiently create and submit AERs that comply with FDA standards, following the formats established by both MedWatch and CIOMS. This organized approach not only bolsters adherence to regulatory guidelines but also significantly enhances the oversight of patient safety during the course of clinical trials. Furthermore, the tool's user-friendly interface facilitates collaboration among multiple stakeholders, contributing to a more transparent and accountable research environment.
What is MediaLab Intelligent Quality Engine (IQE)?
MediaLab's Intelligent Quality Engine (IQE) solution is engineered to provide efficient automation for managing non-conforming events in laboratories. By eliminating reliance on traditional paper-based manual investigations and corrective and preventive action (CAPA) procedures, IQE not only reduces costs but also enhances your quality improvement initiatives. This innovative system ensures compliance with corrective and preventive action standards recognized by organizations such as CAP, the Joint Commission, ISO, and various other accreditation entities. As a result, you will experience a more efficient and streamlined process that aids in meeting regulatory requirements. Begin by utilizing our pre-designed online form templates or take the opportunity to customize your own. Empower your employees to report issues as soon as they arise, and MediaLab will efficiently guide your event through every stage of the management lifecycle, including initial reporting, risk assessment, resolution, and evaluations of change effectiveness. Additionally, your existing processes and forms will integrate seamlessly with IQE, enhancing your laboratory's operational efficiency and compliance efforts. Ultimately, adopting IQE leads to a more proactive approach to quality management.
Integrations Supported
MediaLab Document Control
API Availability
Has API
API Availability
Has API
Pricing Information
Pricing not provided.
Free Trial Offered?
Free Version
Pricing Information
Pricing not provided.
Free Trial Offered?
Free Version
Supported Platforms
SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux
Supported Platforms
SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux
Customer Service / Support
Standard Support
24 Hour Support
Web-Based Support
Customer Service / Support
Standard Support
24 Hour Support
Web-Based Support
Training Options
Documentation Hub
Webinars
Online Training
On-Site Training
Training Options
Documentation Hub
Webinars
Online Training
On-Site Training
Company Facts
Organization Name
Atlant Systems
Company Website
atlantsystems.com/atlant/solutions/atwatch-ae/
Company Facts
Organization Name
MediaLab
Date Founded
1995
Company Location
United States
Company Website
www.medialab.com/iqe-for-laboratories
Categories and Features
CAPA
Audit Management
CAPA Planning
Change Management
Complaint Management
Incident Management
Nonconformance Tracking
Quality Control
Risk Management
Root Cause Analysis
Training Management
Categories and Features
CAPA
Audit Management
CAPA Planning
Change Management
Complaint Management
Incident Management
Nonconformance Tracking
Quality Control
Risk Management
Root Cause Analysis
Training Management
LIMS
Audit Trail
Certificates of Analysis
Data Import / Export
Electronic Laboratory Notebook
Inventory Management
Lab Instrument Interface
Reporting & Statistics
Sample Tracking
Specification Management
Workflow Management