New and Updated Features
You can now send a reminder about a specific task you’d like assignees to complete. Select “More Actions” in the Viewer, then choose “Send reminder(s).” Each assignee you select will be notified.
If you are assigned any tasks in the review column for five days or longer, you will receive a daily notification until the tasks are complete. The notification displays a count of all of the waiting tasks. It links you to the Jobs board, which is automatically filtered to show tasks assigned to you and sorted by assigned date (ascending).
A note on assigned dates: The assigned date is the date a task was made available to you. The task may be assigned specifically to you, or it may be assigned to a group.
Jobs Board Improvements
Expiration Dates and Dates of First Use
We updated the expiration date and date of first use fields so that they are easier to use and more accurate.
System-Set Expiration Date
You no longer need to set a specific expiration date. Instead, you can set the expiration date to a specific amount of time (e.g.: 1 year) after a document is approved for use. You can continue to specify a date when needed.
When you prepare a document for review, we now check to make sure that the expiration date and date of first use are not set in the past. We also make sure the date of first use occurs before the expiration date.
FDA Submissions Updates
We made a few small improvements to FDA submissions.
When you add documents to a submission, you now have the option to include supporting document uploads in addition to references.
- Submissions managers receive an email and in-app notification when a new document is ready to be added to a submission.
- Content owners and initiators receive an email and in-app notification after their document has been marked as ready for dissemination.
Document Status Changes
We changed how document statuses work for documents that must be submitted to the FDA. The changes help improve compliance by preventing documents from being used before they are ready.
After a job is complete, and assuming a document has reached its date of first use, the document status now displays like this:
|Submission status||Document status
Note: The document status labels may vary slightly depending on your company’s configuration.
|NA; the document has not been added to a submission yet.
In submission prep
|Submitted to the FDA||Approved for use|
|Ready for dissemination||Ready for dissemination|
- We fixed an issue where pre-populated fields were not saved on new document versions. The issue applied in scenarios where you didn’t make other changes to properties. Now, when you view properties and some fields are pre-populated, you’ll be prompted to save.
- If your configuration requires a file name for a document, in the past you may have run into a validation error if you uploaded a document after filling out properties. You will no longer see this error.
- Previously, you may have run into an edge case issue if the most recent version of a document expired before it reached its date of first use. In this scenario, the system generated an error when it attempted to expire an earlier version of the document. This has been resolved.
- August 5, 2021: System Change Memo and Validation Documentation
- August 30, 2021: System Change Memo
- November 1, 2021: System Change Memo