Regulatory Open Forum

 View Only
Expand all | Collapse all

All pages of the submission are numbered

  • 1.  All pages of the submission are numbered

    Posted 13-Jan-2020 06:56
    Hi All. 

    All pages should be numbered in such a manner that information can be referenced by page number. This may

    be done either by consecutively numbering the entire submission, or numbering the pages within a section (e.g.,

    12-1, 12-2…).

    How have people managed the page numbering within their submissions? On first look, it is straight forward, you just number 1 - x  for each document right! 

    I will take a guess that most submissions would be made up of different documents, volumes / sections where each would have their own page numbers! How have you demonstrated this on the RTA checklist as there is only a column for entering the page number, not document number. 

    Thanks
    James







    ------------------------------
    James
    Head of QARA
    UK
    ------------------------------


  • 2.  RE: All pages of the submission are numbered

    Posted 14-Jan-2020 02:47
    Hi James,

    Unfortunately I have found inconsistencies in FDA reviewers in this regard.  Some are ok with just section numbering, while a few others (maybe old school) want the submission numbered from 1 to 345.  I remember the good 'ole days where we would print everything out and then had a number stamp we had to flip the number each time and go through the page numbering.  Myself personally, I just number each of the sections with the page numbers so 12-1, 12-2, 12-3; 13-1, 13-2, 13-3; etc.  It is quite clear all the files are numbered, all the exhibits were numbered, so navigating through each of the sections is quite clear.  However it was just recently had a reviewer want all pages numbered consecutively ... shrugs.

    ------------------------------
    Richard Vincins RAC
    Vice President Global Regulatory Affairs
    ------------------------------



  • 3.  RE: All pages of the submission are numbered

    Posted 14-Jan-2020 03:15
    Wow, I cant even think begin to think about how painful that must have been! It must have taken hours to number each page by hand! 

    How do you handle having more than one document in a section? My submission is a SaMD and therefore under the software section I will have about 15 documents! Each of these documents are page numbered and the RTA does not really afford the space to write the document number and then page number. I have attached an example to demonstrate. The document numbers and pages are just examples. 


    ------------------------------
    James
    Head of QARA
    UK
    ------------------------------



  • 4.  RE: All pages of the submission are numbered

    Posted 14-Jan-2020 03:32
    It did take hours haha.

    Again, this is my own personal methods for doing submissions - for me it was easier and kept things "cleaner" when there are multiple documents sometimes hundreds of documents (Exhibits).  I utilise a similar indexing structure as you have, but Section 16 - Software is the main document.  So I have Section 16 which is usually between 5 to 20 pages, so 16-1, 16-2, 16-3, 16-4, etc., located in the footer of the single document which is a description and summary of the section.  Then all the software documents were included as Exhibits.  So in your example PRS is Exhibit 16-A, Project Glossary is Exhibit 16-B, Risk Analysis is Exhibit 16-C and so forth.  In the eCopy submission Section 16 and each of the Exhibits are individual PDF files.  Putting all the documents together in one file was hard to manage internally, but then when it did come to page numbering, did get confusing.  Each document was its own PDF file in the eCopy, e.g. 045_Exhibit 16-A PRS, 046_Exhibit 16-B Project Glossary, 047_Exhibit 16-C Risk Analysis and so on.  It looks like you are already doing something similar because you have document 16-1, 16-2, 16-3, etc. based on your index, so we might be talking about a similar method.

    ------------------------------
    Richard Vincins RAC
    Vice President Global Regulatory Affairs
    ------------------------------



  • 5.  RE: All pages of the submission are numbered

    Posted 14-Jan-2020 05:19
    Did you break cover at any point and stamp your colleagues foreheads! haha.

    Thanks for your insight. I think we are following the same kind of method which is reassuring for me!

    ------------------------------
    James
    Head of QARA
    UK
    ------------------------------



  • 6.  RE: All pages of the submission are numbered

    Posted 14-Jan-2020 16:50
    Edited by Julie Omohundro 14-Jan-2020 16:52
    Yeah, Richard, but did you ever manually number the pages of an original PMA, or were you just doing those skinny little 510(k)s?

    [Insert "bratty kid sticking her tongue out" emoji here]

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------



  • 7.  RE: All pages of the submission are numbered

    Posted 15-Jan-2020 01:53
    Oh yes, I had the pleasure of doing page numbering for a PMA and an NDA haha.  Wish I had some photos of doing that ... was even pre-smart phones and selfies !

    ------------------------------
    Richard Vincins RAC
    Vice President Global Regulatory Affairs
    ------------------------------



  • 8.  RE: All pages of the submission are numbered

    Posted 15-Jan-2020 12:44
    Omigosh, an NDA.  I'm surprised you're done already, lol.  I trust a suitable amount of alcohol was consumed afterwards.

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------



  • 9.  RE: All pages of the submission are numbered

    Posted 15-Jan-2020 12:09
    haha, you guys are too funny! We also went with section numbering and the Agency seems to be fine with it. 


    ------------------------------
    Jo Huang RAC
    Sr. Regulatory Affairs Specialist
    Athens TX
    United States
    ------------------------------



  • 10.  RE: All pages of the submission are numbered

    Posted 15-Jan-2020 12:30
    If your regulatory authority requires you to have sequential page numbering of your entire submission, you can do this electronically using Adobe Acrobat. It's a bit painful (though not as painful as manually stamping each page!). This can only be done when the entire submission is 100% complete - any changes will require starting the page numbering over again. So of course it requires adding an extra day (or more) into your timelines.

    My method is to list all the documents to be included in the submission, in order, with their page counts. I then calculate the entire page count of the submission and the page numbers of each section (e.g., document X runs from pages 1135 to 1157). I have a very basic Excel spreadsheet that calculates this for me. (Word of warning: you really want to triple check to make sure this is correct so you don't have to redo everything due to a calculation/counting error. Guess how I know.)

    Then I go into each PDF individually and add page headers/footers using Acrobat. Even if your documents already have headers/footers, you can add new ones that sit very close to the top/bottom of the page. I include the total pagination of the document (e.g., page 1135 of 8012) and whatever other information I want. I then save this header/footer combination with a name and save a new paginated copy of the PDF. Before closing, I confirm that the first and last pages of the file are numbered as I expected (e.g., "page 1135 of 8012" to "page 1157 of 8012"). 

    Repeat ad nauseum until all files have been paginated. Note that since you have saved your header/footer combo with a name, you can easily apply it to each file without having to manually set each option; you just need to change the starting page number for each file. This also means the headers/footers are the same for each file, giving a consistent look to your entire submission. 

    Obviously these instructions are abbreviated, but hopefully this gives enough information to help people figure it out if they'd like to try it. And of course this takes quite a bit of time for a large submission - but it's actually very workable for a smaller submission and, in my opinion, can help provide additional cohesion and structure to aid the reviewer.

    ------------------------------
    Jennifer Cabralda, RAC (US, CAN)
    Senior Manager, Regulatory Affairs
    Richmond, BC, Canada
    ------------------------------



  • 11.  RE: All pages of the submission are numbered

    Posted 16-Jan-2020 07:51
    Man,  it is too funny what we all do.. I miss having my Regulatory Publishing group back in Pharma days at 3M.

    But now I make one word document that is comprised of cover page, TOC, RTA, lists of  Tables, Figures and Appendices and text of Sections 1-20.   That is all sequentially numbered 1-X, with hyperlinks throughout, including hyperlinks in the RTA, and lists of Tables and Figures to the actual in the main body. Tables and Figures are numbered by section (Table 16-[1], 16-[2], etc.). Then I save that as a pdf to maintain the links (print as pdf doesn't save links).  That pdf file becomes the first file " ___001 body text".

    The Appendices are sequentially numbered either in the order they appear in the document if that makes sense or by type of document grouped (Appendices 1-10 might be software docs, 11-14 labeling).  Each Appendix is its own pdf.  So the entire submission is usually pdf file based.  






    ------------------------------
    Ginger Cantor, MBA, RAC
    Founder/Principal Consultant
    Centaur Consulting LLC
    River Falls, Wisconsin 54022 USA
    715-307-1850
    centaurconsultingllc@gmail.com
    ------------------------------