Required Roles: Editor
Required Permissions: Edit
Kivo includes standardized Quality structures, including IMPD for EU Quality and US FDA Drug Substance and Drug Product folders that follow the EDM reference model and ICH numbering conventions. Add a new drug substance or product to a quality section to build out a full folder structure that covers all ICH sections.
Step 1. Navigate to the Quality folder in Regulatory.
a)Click on the blue + icon.
b) Options appear to create New Drug Product, New Drug Substance, New IMPD. Select the appropriate option.
Step 2. Type in the name of the new drug. In the example below, Drug Product was chosen, and the name is Isocure. Click the Create Drug Product button.
Step 3. The New Drug Product section and subsequent subfolder structure are auto-created for Isocure.