Adverse Event Reporting
For Microsoft Dynamics GP customers who are required by the FDA to track
information related to Adverse Events and to file FDA Form 3500A.
Adverse
Event Reporting provides the capability to track all Adverse Events within
Dynamics GP, maintain a database of those Events including disposition
information, and produce the required FDA reporting documents associated
with Adverse Events.
Distinguishing Features
• Provides a central, secure and controlled system for tracking, analyzing
and reporting on Adverse Events.
• Operates seamlessly with Merit Solutions Audit Trails. All changes to Adverse
Event records are tracked, recorded and maintained in accordance with
FDA 21 CFR Part 11 requirements.
• Produces and records submission of MedWatch form 3500A.
• Tracks standardized information such as details related to MeDRA, National Drug
Code (NDC), and Manufacturing Protocol Number.
• Enables analysis of disposition and trend information for all Adverse
Events.
• Supports the case capture, management, reporting, and analysis of adverse event
cases for all medical products from all sources.
• All changes to Adverse Event records are tracked, recorded and maintained in Merit
Solutions Audit Trails in accordance with FDA 21 CFR Part 11 requirements.
Adverse Event Reporting tracks information required for MedWatch Form 3500A.
The information is captured within the Microsoft Dynamics GP database for easy
access and analysis of all Adverse Events. In the AER start screen, access each
section of the 3500A form by clicking the corresponding form section.
Merit
Solutions
1749
S. Naperville Road Suite 200 Wheaton, Illinois 60187
Phone:
(630) 614-7133
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