Average Ratings 1 Rating
Average Ratings 0 Ratings
Description
PvEdge is a state-of-the-art cloud-based pharmacovigilance software crafted to deliver comprehensive and compliant safety solutions for pharmaceuticals, medical devices, vaccines, and their combinations. It features an all-encompassing safety database that streamlines the management of pharmacovigilance intake, case processing, submissions, AI-driven analytics, and safety signal detection within a single user-friendly interface. This platform is designed to meet both current and forthcoming regulatory standards, including 21 CFR Part 11, ANNEX 11, GxP, and GDPR, thus ensuring worldwide compliance. By harnessing the power of advanced automation through AI and machine learning technologies, PvEdge significantly boosts the efficiency of drug safety database management. Notable functionalities encompass automated literature review, expedited ICSR submissions, intelligent triage processes, automated signal detection, and streamlined document automation. Additionally, the system incorporates a controlled document management feature that facilitates the creation, oversight, and dissemination of essential pharmacovigilance documentation, alongside a risk-based enterprise quality management framework aimed at establishing robust quality control processes and maintaining meticulous training records. Through these diverse capabilities, PvEdge stands out as an invaluable tool for organizations committed to upholding the highest standards in drug safety.
Description
Honeywell's TrackWise Digital® serves as an innovative cloud-based Quality Management System (QMS) aimed at enhancing the efficiency of quality and compliance processes within organizations. Drawing on nearly thirty years of expertise in the field, it features integrated modules that cater to various elements of quality management, such as document control, training oversight, and corrective and preventive actions (CAPA). The platform utilizes cutting-edge digital technologies, including artificial intelligence and machine learning, to deliver actionable insights in real-time, which fosters a proactive approach to quality management. Its adaptable, modular framework ensures smooth integration with current enterprise systems, allowing for quick deployment and growth. By optimizing quality processes and maintaining adherence to industry regulations, TrackWise Digital® enables organizations to accelerate product launches while effectively reducing risks. This comprehensive system not only enhances operational efficiency but also supports continuous improvement initiatives across the quality management spectrum.
API Access
Has API
No
API Access
Has API
No
Integrations
CLEEN
No
Res_Q
No
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Pricing Details
$200 per month
Free Trial
Yes
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)
Yes
Online Support
Yes
Customer Support
Business Hours
No
Live Rep (24/7)
Yes
Online Support
No
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
Yes
In Person
Yes
Types of Training
Training Docs
Yes
Webinars
Yes
Live Training (Online)
Yes
In Person
Yes
Vendor Details
Company Name
Sarjen Systems
Founded
1998
Country
India
Website
pvedge.sarjen.com
Vendor Details
Company Name
Honeywell International
Founded
1906
Country
United States
Website
www.spartasystems.com
Product Features
Product Features
Quality Management
Audit Management
Yes
Complaint Management
Yes
Compliance Management
Yes
Corrective and Preventive Actions (CAPA)
Yes
Defect Tracking
Yes
Document Control
Yes
Equipment Management
Yes
ISO Standards Management
Yes
Maintenance Management
Yes
Risk Management
Yes
Supplier Quality Control
Yes
Training Management
Yes