Regulatory
By Casey1 author8 articles
eCTD Viewer Errors: Understanding Validation Errors and How to Resolve ThemWhy the Kivo eCTD Viewer may flag an imported submission with a validation error, what the most common error types mean, and how to resolve them.
Navigating and Updating Submission Application in the Submission builderThe submission application like NDA, IND are prebuilt in Kivo. A user can add child sections, siblings to the structure. The application c...
View a document's association with Submissions, eCTDs, and Alias locationsPlease note that user with reader and editor permissions have access to the audit trail of the documents.Here are instructions to access a...
Import an eCTD ArchivePlease note that for importing an eCTD Archive, the Archive must be a zip file. To import a file you must have Editor permissions on the z...
Modifying the name of a SubmissionClick on Submissions Builder
Select a category …
Changing the Name of a Category in Submission BuilderClick on Submission
Click on the category to rename
Click on the Pencil to enable editing of the name field
Change the name
Cli...
Select a Source or PDF in a SubmissionClick on Submissions
Select a Category, Product, Application, and submission
Select a module
The list of Documents in that module a...