Regulatory Open Forum

Dear RAPS,

Would anyone have or be willing to share their tips, tricks or best practice advice for organizing their regulatory files and folders.  These folders would store pdfs, documents and other resources for our team on a shared local "hard-drive."  What ways have you sorted and organized communication with the FDA or other agencies?  What have you done that might have helped everyone on the team find old and file new information?  Are there structures you put in place a few years ago that you might now regret (in terms of file naming or access or sort method).  I appreciate any recommendations here and wish you all well today.  Thank you.

------------------------------
Andrew Hadd
Director of Regulatory Affairs
Austin TX
United States
------------------------------

This message was posted by a user wishing to remain anonymous

Great, great question and good time to ask.

For each project, I've created a folder and then within it, a folder called CHRONOS YEAR.

Within each CHRONOS Year folder, I store communication from FDA in the following format: 20XX-MM-DD application number to or from health authority name short description. If it were an E-mail, I'd PDF the E-mail into this format. Also, don't forgot to OCR any PDF scanned documents so they can be searched. Acrobat has a search features where you can search entire directories for specific content.

If the interactions with countries were vastly different, I might put each county into a separate folder.

For submissions sent, I sometimes would the communication, other times may put a link to the electronic submission.

In this one, one can sort alphabetically and get a chronological history of the product.

This could also be done in OneNote, but sometimes OneNote is a bit unstable, so sticking to traditional directories may feel safer. I am a big Evernote user for regulatory articles, but not sure storing correspondence in Evernote would be idea (though it could be done).

If there are other documents, like regulatory strategies or internal meeting minutes, opinions from consultants, or approval summaries of approved competitor products, I'd keep them in a separate folder. I always start the file name though with the same numbering scheme 20XX-MM-DD so it is easily sorted. You can also make sure to put key words (e.g. tags) in the file name to help search for it later. If these discussions were related to a health authority correspondence or submission, I'd copy a shortcut from the CHRONOS folder to this directory, so it could still be seen in that context.




Original Message:
Sent: 26-Jun-2020 11:06
From: Andrew Hadd
Subject: Tips for Organizing Communication and Regulatory Folders

Dear RAPS,

Would anyone have or be willing to share their tips, tricks or best practice advice for organizing their regulatory files and folders.  These folders would store pdfs, documents and other resources for our team on a shared local "hard-drive."  What ways have you sorted and organized communication with the FDA or other agencies?  What have you done that might have helped everyone on the team find old and file new information?  Are there structures you put in place a few years ago that you might now regret (in terms of file naming or access or sort method).  I appreciate any recommendations here and wish you all well today.  Thank you.

------------------------------
Andrew Hadd
Director of Regulatory Affairs
Austin TX
United States
------------------------------

Thank you for the reply and suggestions on file management especially the inclusion of optical character recognition (OCR) within PDFs.  I have been plagued by that challenge in the past where a treasure trove of technical reports and other documents had only been scanned.   They were very challenging to search.  Your suggestion should not be underestimated in value and reminds me of the quote from Lew Platt, former CEO of Hewlett Packard:  "If only HP knew what HP knows, we'd be three times more productive."  Thanks again.   

Andrew Hadd

------------------------------
Andrew Hadd
Director of Regulatory Affairs
Austin TX
United States
------------------------------

Original Message:
Sent: 26-Jun-2020 14:46
From: Anonymous Member
Subject: Tips for Organizing Communication and Regulatory Folders

This message was posted by a user wishing to remain anonymous

Great, great question and good time to ask.

For each project, I've created a folder and then within it, a folder called CHRONOS YEAR.

Within each CHRONOS Year folder, I store communication from FDA in the following format: 20XX-MM-DD application number to or from health authority name short description. If it were an E-mail, I'd PDF the E-mail into this format. Also, don't forgot to OCR any PDF scanned documents so they can be searched. Acrobat has a search features where you can search entire directories for specific content.

If the interactions with countries were vastly different, I might put each county into a separate folder.

For submissions sent, I sometimes would the communication, other times may put a link to the electronic submission.

In this one, one can sort alphabetically and get a chronological history of the product.

This could also be done in OneNote, but sometimes OneNote is a bit unstable, so sticking to traditional directories may feel safer. I am a big Evernote user for regulatory articles, but not sure storing correspondence in Evernote would be idea (though it could be done).

If there are other documents, like regulatory strategies or internal meeting minutes, opinions from consultants, or approval summaries of approved competitor products, I'd keep them in a separate folder. I always start the file name though with the same numbering scheme 20XX-MM-DD so it is easily sorted. You can also make sure to put key words (e.g. tags) in the file name to help search for it later. If these discussions were related to a health authority correspondence or submission, I'd copy a shortcut from the CHRONOS folder to this directory, so it could still be seen in that context.




Original Message:
Sent: 26-Jun-2020 11:06
From: Andrew Hadd
Subject: Tips for Organizing Communication and Regulatory Folders

Dear RAPS,

Would anyone have or be willing to share their tips, tricks or best practice advice for organizing their regulatory files and folders.  These folders would store pdfs, documents and other resources for our team on a shared local "hard-drive."  What ways have you sorted and organized communication with the FDA or other agencies?  What have you done that might have helped everyone on the team find old and file new information?  Are there structures you put in place a few years ago that you might now regret (in terms of file naming or access or sort method).  I appreciate any recommendations here and wish you all well today.  Thank you.

------------------------------
Andrew Hadd
Director of Regulatory Affairs
Austin TX
United States
------------------------------

Hello Andrew,

This is an interesting question! I think like all filing systems, it's very personal and dependent on the kind of work you're doing, how many geographies you're working in, etc. But I always think it's helpful to see how different companies manage it, to help get ideas. For context, we're a small medical device company with a few products and a regulatory team of 5. 

Our regulatory folders are on our Windows file server. Within the top-level Regulatory folder, we have lots of subfolders, including Correspondence, Submissions, Intelligence, Education and Training, etc. 

The Submissions folder is split out by geography (we use ISO 2-letter codes for consistency). Within each geography, we have folders for each main project (e.g., a specific clinical trial or marketing submission). Then under those, we have individual sequential folders for each submission. Those folders contain the submission itself, plus all the working files and related correspondence specific to that submission. For example the folder structure might look like this: 

Submissions
--US
----IDE XXXXXX
-------00_Initial Submission
-----------Correspondence
-----------Final Submission
-----------Working Folders
-----PMA XXXXXX
-------00_Initial Submission
-----------Correspondence
-----------Final Submission
-----------Working Folders
-------01_Suppl <Brief Description>
etc. 

Within Correspondence, we store correspondence that is not related to a specific ​​submission, again separated out by geography and then again into subfolders when appropriate. 

We maintain a consistent naming convention for the folders and for individual files, using YYMMDD at the start of each file name so they sort in order. The biggest help in maintaining this consistency is having a single person responsible for filing. We have a separate top-level "Regulatory Working" folder that is our active folder, and when a project is ready to be filed, it's sent to a single person who moves it over to the final folder. Very few of us in the department have write access to our final Regulatory folder. This may be unconventional but has greatly helped in ensuring everything is filed consistently and is thus reasonably easy to find. (We found that otherwise, even with training, everyone tended to file things slightly differently.) This person also keeps logs of what is filed, which can be helpful if searching for a specific file. 

Overall this system works extremely well for us. If we had a large number of projects, top-level folders by project would probably be needed but we do fine without them. Also, it would be better if everything was stored in a proper file management program, which would allow more comprehensive searching. But on the plus side, it's free...and in most cases, searching within Windows (doing a full text search) works OK, although it's slow. 

Hope this gives you some ideas!
Jennifer

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

Original Message:
Sent: 26-Jun-2020 11:06
From: Andrew Hadd
Subject: Tips for Organizing Communication and Regulatory Folders

Dear RAPS,

Would anyone have or be willing to share their tips, tricks or best practice advice for organizing their regulatory files and folders.  These folders would store pdfs, documents and other resources for our team on a shared local "hard-drive."  What ways have you sorted and organized communication with the FDA or other agencies?  What have you done that might have helped everyone on the team find old and file new information?  Are there structures you put in place a few years ago that you might now regret (in terms of file naming or access or sort method).  I appreciate any recommendations here and wish you all well today.  Thank you.

------------------------------
Andrew Hadd
Director of Regulatory Affairs
Austin TX
United States
------------------------------

Jennifer,

Thank you for the detailed suggestions regarding file management and tips for organizing our submission and other regulatory associated records.  Your tip on "one person should be responsible for filing" and keeping a consistent naming convention are well appreciated.  We want to build a working approach that is scaleable with data that is easily recovered and able to be easily learned by new team members.  Further, this suggestion seems to handle regional components and pre-submission or non-submission related information well.  Thanks again for your reply!

Cheers,

Andrew Hadd

------------------------------
Andrew Hadd
Director of Regulatory Affairs
Austin TX
United States
------------------------------

Original Message:
Sent: 26-Jun-2020 19:43
From: Jennifer Cabralda
Subject: Tips for Organizing Communication and Regulatory Folders

Hello Andrew,

This is an interesting question! I think like all filing systems, it's very personal and dependent on the kind of work you're doing, how many geographies you're working in, etc. But I always think it's helpful to see how different companies manage it, to help get ideas. For context, we're a small medical device company with a few products and a regulatory team of 5.

Our regulatory folders are on our Windows file server. Within the top-level Regulatory folder, we have lots of subfolders, including Correspondence, Submissions, Intelligence, Education and Training, etc.

The Submissions folder is split out by geography (we use ISO 2-letter codes for consistency). Within each geography, we have folders for each main project (e.g., a specific clinical trial or marketing submission). Then under those, we have individual sequential folders for each submission. Those folders contain the submission itself, plus all the working files and related correspondence specific to that submission. For example the folder structure might look like this:

Submissions
--US
----IDE XXXXXX
-------00_Initial Submission
-----------Correspondence
-----------Final Submission
-----------Working Folders
-----PMA XXXXXX
-------00_Initial Submission
-----------Correspondence
-----------Final Submission
-----------Working Folders
-------01_Suppl <Brief Description>
etc.

Within Correspondence, we store correspondence that is not related to a specific ​​submission, again separated out by geography and then again into subfolders when appropriate.

We maintain a consistent naming convention for the folders and for individual files, using YYMMDD at the start of each file name so they sort in order. The biggest help in maintaining this consistency is having a single person responsible for filing. We have a separate top-level "Regulatory Working" folder that is our active folder, and when a project is ready to be filed, it's sent to a single person who moves it over to the final folder. Very few of us in the department have write access to our final Regulatory folder. This may be unconventional but has greatly helped in ensuring everything is filed consistently and is thus reasonably easy to find. (We found that otherwise, even with training, everyone tended to file things slightly differently.) This person also keeps logs of what is filed, which can be helpful if searching for a specific file.

Overall this system works extremely well for us. If we had a large number of projects, top-level folders by project would probably be needed but we do fine without them. Also, it would be better if everything was stored in a proper file management program, which would allow more comprehensive searching. But on the plus side, it's free...and in most cases, searching within Windows (doing a full text search) works OK, although it's slow.

Hope this gives you some ideas!
Jennifer

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

Original Message:
Sent: 26-Jun-2020 11:06
From: Andrew Hadd
Subject: Tips for Organizing Communication and Regulatory Folders

Dear RAPS,

Would anyone have or be willing to share their tips, tricks or best practice advice for organizing their regulatory files and folders.  These folders would store pdfs, documents and other resources for our team on a shared local "hard-drive."  What ways have you sorted and organized communication with the FDA or other agencies?  What have you done that might have helped everyone on the team find old and file new information?  Are there structures you put in place a few years ago that you might now regret (in terms of file naming or access or sort method).  I appreciate any recommendations here and wish you all well today.  Thank you.

------------------------------
Andrew Hadd
Director of Regulatory Affairs
Austin TX
United States
------------------------------