Enhancement Details

Enhancements to Customer Experience Management Reporting

PTC Windchill 10.2 contains enhanced Customer Experience Management reporting features that allow users to create and submit regulatory reports for Electronic MedWatch (eMDR), Canada, Vigilance, Australia, Japan, and Israel. Users can view and print the reports at any time.

Product Information

Product PTC Windchill
Quality Solutions
Product / Module PTC Windchill Customer Experience Management
PTC Windchill QMS
Version 10.2
Datecode F000
Product Functional Area Quality
User Interface Location 
Processes, Initiatives, and Best Practices Complaints and customer feedback
Quality and Reliability Management

Benefits and Description

PTC Windchill 10.2 contains enhanced Customer Experience Management reporting features, allowing users to create and submit regulatory reports for Electronic MedWatch (eMDR), Canada, Vigilance, Australia, Japan, and Israel. Users can view and print the reports at any time.

This new functionality gives companies the ability to perform regulatory reporting submissions to comply with field incident reports related to products.

eMDRs are submitted to the Food and Drug Administration (FDA) through the Electronic Submissions Gateway (ESG), which enables regulatory information to be securely submitted for review using a single point of entry. If the submission is successful, users receive three acknowledgements based upon the acceptance from the FDA.

For more information, see the Regulatory Decisions and Reports topic in the PTC Windchill Help Center. Tip: Enter the topic name in the PTC Windchill Help Center search field to easily navigate to the topic.

Multimedia

Images
eMDR Form
eMDR Form
Viewable PDF of eMDR
Viewable PDF of eMDR

PTC Community