Article - CS275544
The Mandatory Medical Device Problem Reporting Form for Industry (Canada Report) selects the No for 1. i and 1. ii even when the Reporter type is selected as Manufacturer in Windchill QMS
Modified: 06-Dec-2017
Applies To
- Windchill PDMLink 11.0
Description
- The Mandatory Medical Device Problem Reporting Form for Industry (Canada Report) selects the No for 1. i and 1. ii even when the Reporter type is selected as Manufacturer
- Steps to reproduce:
- Create a Customer Experience
- Navigate to Customer Experience Management tab and Create New Product Activity from the Product Activities table. Select type Regulatory Decision Canada
- From the Related task -> Access the Evaluate Customer Experience -> Actions Create Evaluation
- Select the field Yes for “ Does this event meet the criteria for a Complaint?” and “Is this event potentially safety reportable?”
- Complete the task
- From the Related task -> Canada Report Decision
- Complete the task
- From the Related task -> Canada Report Creation
- Actions -> Enter Report Details
- Select Reporter as Manufacturer
- Select Blank Value for both the queries ( ii & iii ) in A1 section.
- The report generated with the value selected as No even when the Reporter is selected as Manufacturer.
This is a printer-friendly version of Article 275544 and may be out of date. For the latest version click CS275544