Quality Control is an important part of any submission project. While there are many aspects of an overall submission QC program, this post focuses on the final QC process for eCTD submissions that takes place after the submission is published and the publishers have done their QC. This effort is the last chance to catch errors and omissions before submissions go to the agency. I generally refer to this process as Team QC, since it brings all the authors and content owners back to check the submission. A well-designed Final QC process can run through a large submission in 1-2 days.
Tag Archive: eCTD Viewer
Final Submission QC
eCTD Leaf Titles
Leaf titles are an important part of eCTD submissions, but they are rarely considered outside of Regulatory Operations. While authors tend to focus on what their file is called, reviewers look at leaf titles, not file names. Putting meaningful information into leaf titles makes submissions easier to navigate, and makes reviewers’ jobs easier.
The Importance of eCTD Viewers
It’s hard for most people to grasp important eCTD concepts like lifecycle and granularity until they’ve seen them in action. The best way I’ve found to teach these concepts is by using an eCTD viewer. There are a number of viewers on the market, ranging from free desktop applications to large scale web-based viewers. While I have my favorites, any of them will serve to educate authors, project teams, and Regulatory staff about granularity and document lifecycles. I’m not exaggerating when I say that getting a viewer in front of people is probably the best thing you can do to help your company successfully adopt the eCTD.