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.
Why Do Final QC?
Final QC serves 2 main purposes. The first is to give authors one last chance to look at their content in the format the agency will be reviewing. The second is to have someone outside the publishing group verify that all the documents published correctly. Both issues are important. The first is a subtle way to check the content, and the second is a more direct way to check the formatting.
Types of Errors Often Found
The types of errors that turn up in Final QC address both content and format. Sometimes formatting is unclear and the publishers have to decide how a document should look. Final QC allows authors to verify that decisions made during the publishing process didn't adversely affect their content. Perhaps the most important aspect of Final QC is that it allows authors to look at their content with a fresh set of eyes. As submission deadlines near, there is typically a mad dash to finalize documents and hand them off to Regulatory Publishing. Authors are so anxious to meet their deadline that they may overlook simple mistakes. Final QC gives them a chance to catch those mistakes before the documents go to the agency.
I think this process works because the authors look at the documents differently. While on deadline, their focus becomes the deadline. When they do Final QC, their focus is on quality. The fact that they had a few days away from the document while it was in publishing helps, as does the fact the authors hand off Word documents and QC PDFs. This should not be an opportunity for authors to check every data point. That level of QC needs to be done before handing documents off for publishing.
To manage Final QC for a large submission, I find it helpful to assign responsibility to a key person in each function. Those people can then assign document-level responsibility to knowledgeable authors for each section. I generally provide a 5 minute orientation to the submission so everyone knows how to navigate, and a checklist for the Final QC process. Typically, I ask authors to check the following items during Final QC:
- This is the correct document or report, and it is properly identified in the eCTD structure
- The document is complete and accurate, and contains the correct versions of all relevant tables, figures, appendices, and amendments
- There are no blank, extraneous, or unreadable pages, and all pages are oriented correctly on screen
- Every hyperlink, except those in the TOC, points to the correct table, figure, section , or file, and that the referenced information is relevant to the source material
The final step, checking the hyperlinks, is critically important. A publisher can easily interpret an instruction to link to Table 7, but they may not be able to determine whether Table 7 is actually relevant to the material in the source paragraph.
Once the Final QC is complete, Regulatory Publishing needs to determine how to fix any issues discovered during the process. Depending on the severity of the issue and the amount of time left before deadline, you may chose not to fix some issues.
Using an eCTD Viewer
Final QC is an excellent opportunity to familiarize authors with the capabilities of your company's eCTD viewer. The more the Final QC environment mimics the agency review environment, the more the authors will take Final QC seriously. Using an eCTD viewer helps authors begin to understand the impact of document lifecycle decisions. Some viewers now have the capability to manage review comments, which makes capturing findings during Final QC very easy. If your viewer does not have this capability, you can easily devise a paper system to track any QC findings. Here's a link to a sample QC sheet in MS Word format that you can modify for your own use: Final QC Sheet.
Final QC is an important part of every submission. A well-designed process is very efficient, and can be scaled to include many people. It helps authors see their documents the way that reviewers will look at them, and can virtually eliminate silly mistakes.