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FDA 21 CFR Part 11 & EU DIRECTIVE 1999/93/EC: digital signatures

digital signatures digital records

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#1 bacon

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Posted 23 July 2013 - 09:36 PM

I wasn't quite sure where to post this question... 

 

I know that Safefoods 360 and Gael Ltd’s “Q-Pulse” and a handful of other companies handle document control catering to GFSI benchmark requirements, however when it comes to the actual food manufactures having much concern over this issue, I find very little and only references in the tightly scrutinized pharmaceutical/medical device industries.

 

So when it comes to these kinds of digital record (only with the predicate rules that apply to food packers), I am wondering what people are seeing out there in the food manufacturing industry... (i.e. - not concerned with food import, pharmaceutical or medical device industries submitting digital documents to FDA 21 CFR part 11 requirements)

 

Cheers,

-Cory


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#2 bacon

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Posted 01 September 2013 - 02:38 AM

Come on! 350 view and NOBODY is dealing with Digital Signatures and Electronic Records!!??

 

The complexity and growth of Document Control in Food Safety/Quality systems and the heavy paperwork burden is giving rise to Digital Signatures and Electronic Record handling software. The two major legal reference I have found are 21 CFR Part 11 and EU DIRECTIVE 1999-93-EC concerning Digital Signatures and Electronic Records (I haven't looked into what Australia/NZ require).

Anybody getting senior management support in having these types of software systems to support QA/QC management of paperwork burden?


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#3 Charles.C

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Posted 01 September 2013 - 04:13 AM

Dear baron,

 

My personal (tiring) experiences are 100% manual.

 

I presume the major item in yr post is electronic document control systems.

 

Not sure if you have already searched this forum but i think i recall several previous threads here discussing this topic and commercial systems like the ones you mention ? Including comments from users also, from memory.

 

Rgds / Charles.C


Kind Regards,

 

Charles.C


#4 bacon

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Posted 03 September 2013 - 05:57 PM

Thank you Charles.C. I hear you about the 100% paper manual stuff.

 

I did search a while back but will have to do it again it seems.

 

Just surprised that nobody really responded.

Cheers

-B


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