Regulatory Publishing Software Q&A

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During a recent webinar presentation, GlobalSubmit demonstrated how IND & Pre-IND companies use our software tools to see the same views as the FDA; build their application as the FDA sees it; cut days off the time it takes to quality check bookmarks and hyperlinks; improve communications both internally and with the Agency; improve efficiency and meet important deadlines; reduce risk of technical rejections; and more!

We received several great questions during the webinar, but unfortunately did not have time to address all of them. Please find these questions and answers below.

Q: Is it possible to set user permissions to restrict some users from adding content?

A: Yes, you may set user permissions to restrict some users from adding content. In fact, GlobalSubmit provides two levels of access for publishing. One level, also referred to as the Publishing Administrator, has certain rights, such as being able to create and set titles for documents. The standard publishing level does not have the right to do that.

Q: Are different views available in REVIEW, e.g. cumulative and/or current views?

A: There are 5 different views in REVIEW.

1. LifeCycle View lets the user see any lifecycle operations that were done on the submission.

2. Current View shows users current files.

3. Regulatory Activity View groups submissions, also known as sequences, that are part of the same regulatory activity.

4. Sequence View shows all the sequences in your application.

5. Finally, Origin View is what you can use to modify the application when you need to delete or add content.

Q: Is the Validator included in this application, or is it separate?

A: In the small business package, all the four modules are bundled; VALIDATE, REVIEW, PUBLISH, and CROSSCHECK.

Q: Is the system built only for drug INDs, or can it also be used for IVD and medical device application?

A: Although the system is built for other types of applications, such as the NDA, IND, ANDA, BLA, etc., currently we do not support medical devices.

Q: Do you link to outside documents prior to building your submissions, or do you link after it has been built?

A: When using our software, you should link your documents once the submission has been built.

Q: How do you add a child node e.g. 3.2.P.5.4?

A: To add nodes, where it is allowed, all you would have to do is right-click on the section where you want to add the node. Once the context menu is displayed, you can select ‘New’ which will then give you the option to create a child node.

Thank you again to all of those who participated in the webinar. We hold these events regularly, so if you were unable to attend, please visit our Events Calendar to join a future demo.

We look forward to seeing you online!

Author: GS

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