7 results

Results

Task Management

What are some benefits of assigning capabilities?

Publishing

What is the best way to create hyperlinks from one document to many documents?

Version Control

How does ViewPoint control document versioning?

Setting Up Projects

How do I set up a new submission?

eCTD Folder Structure

Q) How do I break out the 3.2.P.4 section?

A) The 3.2.P.4 section is broken out by compendial excipients, and drug specific excipients. All compendial excipients can be put into one folder named 3.2.P.4 – Compendial. The Excipient metadata should be entered as “Compendial”. All drug specific excipients need their own 3.2.P.4 section.

eCTD Metadata

Q) I’m getting a “Content has been deleted” error message in ViewPoint, but the content has not been deleted or removed from the system. Why is this happening?

A) For several sections within the eCTD folder structure, key metadata is mandatory. STF’s in Module 5 and Excipient information in module 3 are examples. If this metadata is not entered in, and the submission is compiled, ViewPoint can not read the document content because it is looking for the metadata first.

Reporting and Metrics

How does Dashboard help senior management within your company?