How to handle the task of Organizing a Regulatory File Room

M

Miraclebeliever

#1
Hello everyone,

I have recently been placed with the task of organizing the regulatory file room. It contains different types of files in 3 ring binders and some are in folders in filing cabinets. The room is not that big and the types of files are 510(k), a few design dossiers, technical files, memo to file, declaration of conformity files and other miscellaneous ones. I am also creating a spreadsheet with all the files in the room. Does anyone have suggestions on how regulatory files are organized or grouped together. I think it would be better to group the files by product families. Is it possible to use different color binders for the different product families?

Also, when creating an excel spreadsheet that lists the technical files and 510(k) what other infomation is important to include in the spreadsheet apart from file name and number? What would be a good system to number the files?

Any ideas on how to do this project will be very helpful. I feel a little overwhelmed because some of the files are in boxes and actually need to be placed inside a file before being put in the cabinets. I also need to come up with a layout of how to arrange the files in the cabinets.

Thanks for your help.
 
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pkost

Trusted Information Resource
#2
Oh dear, I really don't envy you that task! I struggle organising a few shelves of a bookcase.

We currently put each product group in one "file", we seperate out the design file and the "technical file", we don't have to worry about 510k. As the number of products we have increases, I am starting to find that there is a lot of cross reference between files and this makes our current system difficult as it is not always entirely clear which group file a particular document is in. It sounds like you have considerably more documentation than us and so I wouldn't recommend our current way as I would imagine the cross references would be a nightmare.

Depending on how your documents are numbered, how about keeping them in alphanumeric order. Then have a "contents" page that would identify all of the document codes that are in a particular technical file, 510k, design file etc? That way you can always identify the information necessary for each regulatory region and you can handle documents that are in multiple "files".

How you put together the contents page would then become critical and you have to ask yourself "what specific information is someone going to want from this file?" e.g. a particular validation report, CoC etc...is it easy to fine?
 
T

The Specialist

#3
Just as a 'side' to this...

Have you also considered documentation security in this process, such-as fire-safe storage requirements?
 
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