Ready Room Blog
Ready Room Feature Update: GMP Storyboards
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We are very excited to announce a new addition to our Storyboards feature in Ready Room: Good Manufacturing Practice (GMP) storyboards. Ready Room now includes 60 question and answer frameworks to develop GMP storyboards, organized according to 21 CFR Part 211 and FDA's Drug Manufacturing Inspections Compliance Program Manual.
Now, when you pull down the New Storyboard menu in Ready Room, the option "Initialize with expected GXP questions" appears. Select it to view the GCP storyboards on one tab and GMP storyboards on a second tab. Any combination of storyboards can be selected and imported into the inspection. On the storyboard landing page, "GXP Area" now appears as a column heading, so the GCP and GMP storyboards can be easily distinguished.
Like the GCP storyboards, the GMP storyboards include fill-in-the-blank prompts for completing the storyboard. All storyboards can be edited using rich text features, including links to documents in other repositories, such as eTMF and eQMS. We've added an html editor to the suite of editing tools for fine-tuning of storyboard formats.
We received several requests from customers for a bulk delete utility for storyboards, which we have implemented. You can now select storyboards for deletion and remove them with just one click of the Delete button. If a storyboard is deleted in error, it can now be recovered easily using the Recover button, which brings you to a list of deleted storyboards. Open the one you wish to recover and click the Recover button to restore it to the storyboard list.
Finally, we've added the ability to sort by column on the storyboard landing page.
Storyboards are one of the most useful tools in the inspection team's toolbox, and we're happy to be able to expand our frameworks to include GMP topics. Pharmacovigilance is next - stay tuned for updates!
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