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Paper shredder security level

paper shredder security level good documentation practices GDP document control

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#1 matthewcc

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Posted 08 March 2019 - 04:31 PM

Hello there ~

 

Happy Friday ~

 

Does anyone know a recommendation for a paper shredder security level, e.g., level 2, level 3, level 4, level 6, etc.?  (Before today, I didn't know all of these levels even existed.)

 

I'm going to be buying a paper shredder and want to see what might be required, if anything.  We are manufacturing dietary supplements in the United States under FDA regulations including 21 CFR Part 111, 11, 117, 121, etc.  Typically we shred obsolete documents including master manufacturing records (MMRs), batch records, SOPs, etc.  Perhaps this type of security level is more required within financial or human resources areas, but I thought I would see if anything is out there.

 

Thank you in advance,

Matthew



#2 Jpainter

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Posted 08 March 2019 - 11:55 PM

It all depends on risk assessment, in my opinion. If you have proprietary processes or formulas, you may want to invest in a higher security level. I used to work for a large multi-national cooperation who believed that every document they had contained trade secrets, and as such contracted a company to shred documents to the maximum security level. As far as I know FDA does not mandate that documents even be shredded, it is more of a company policy. I am fairly new to FDA however, as most of my experience comes from a USDA background. Hope this helps!



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#3 matthewcc

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Posted 11 March 2019 - 04:57 PM

I think it would be implied that, if you have paper documents, for regulatory purposes under the FDA, you would need to destroy any GMP documents that are obsolete so that the only version you have is the current one for each document.

FDA does not mandate shredding documents.  You could be entirely paperless (who does that??) or destroy your obsolete documents in some other way, such as incineration, etc., or at least remove them from the facility.



#4 Scampi

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Posted 11 March 2019 - 04:59 PM

I think you'll be fine with a cross cut shredder

 

As for e docs....you'd just have to show proof that deleted files have been wiped from the server (you're IT department should be able to sign off on this)


Because we always have is never an appropriate response!


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