UDI Complaints provides a mechanism to collect complaints regarding known UDI Submissions from different sources. It allows users to review and report any appropriate complaints to the regulatory body (establishing a record with follow-up).
How to setup
The application contains all of the data required on start up. The master data can be reset by signing in as an Administrator and navigating to Mock Data and selecting 'Reset Mock Data'.
The application can be requested, downloaded and can then be customised using Studio or Studio Pro to suit your needs.
Administrator - Responsible for the administration of the platform, including technical configuration and data management.
User - General user role for the different account disciplines (see below)
Anonymous - For anonymous access to the application.
Submissions Module - manages the UDI submissions information
Location - to retrieve and store location data
UDI Module - manages the data that in a production system will be stored in other systems
Complaints Module - contains everything directly related to the complaints process
Mock Data - enables creation of sample data for demonstration purposes
TC Connector Sample - a small example module for how to connect into TeamCenter
Custom Admin Module - for administration and custom layouts
Users are linked to account disciplines. These are hard coded into the workflow to route the submissions.
- Product Manager - Responsible for final approval of the complaint
- Quality Manager - Responsible for the QA review of the complaint.
- Regulatory Manager - Responsible for the Regulatory review and submission of the complaint to the Regulator.
Data Model Description
The Submissions Module contains all of the information for management of the submissions process:
- PLM Product Submission - To contain product data and connect to the Submittal Process.
- UDI Product Submission - Designed to be synchronised from TeamCenter, contains the product information.
- Submittal Process - Manages the submittal process. Multiple submittal process can be added for each Product Submission (e.g. for different regions)
- Submittal Info - For all submittal attachments.
- Region - The Region that the Submittal Process is connected to.
- Regulatory Type - The available Regulatory types. Note there is no direct association, the attribute on Submittal Process - Regulatory Type.
The UDI Module data contains:
- ERP data - ERP simulation data for Customer information to be linked to Complaints
- UDI - the UDI information connected to UDI Product submissions
- GUDID Ack - stores acknowledgements from 3rd party systems
- EDG_CDRH_GUDID - GUDID Issuing Agency Simulator
The Complaints module contains:
- Complaint -the complaint and the complaint workflow information
- Complaint Information - any attachments added to the complaint
The application has been designed to leverage mock data and user switcher has been provided for ease of demonstration.
Information can be generated or reset by the administrator by clicking Configurations -> Reset All MockData . This will read the JSON files located in the resources/mockdata folder and create corresponding data within the application. It will also create demonstration workflows at different stages.
A new Complaint can be started by any user by navigating to UDI Overview, selecting a UDI and clicking Add Complaint. The data can then be populated, and once the complaint is saved it will be sent to the Quality Managers inbox. The Quality Manager can then review the complaint, add notes and add attachments before Routing or Rejecting the complaint. If Routed the Complaint will arrive in the Regulatory Managers inbox. The Regulatory manager can carry out the same actions as the Quality Manager, and can also Publish the complaint to the MDR, this will generate acknowledgements from 3rd party systems. Finally the complaint arrives with the Product Manager, who can complete the process and push the complaint to CAPA.
The complaint can be rejected at any stage in the process and that will cancel the complaint.