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#1 jgantomasso

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Posted 27 March 2017 - 06:41 PM

Hi,

 

We work in an ISO 7 cleanroom environment.  Our QC lab does testing and then needs to report those results to the cleanroom.  It takes roughly 30 minutes for staff to clean materials, gown and pass the results into the room.  We were thinking of implementing computer tablets in the cleanrooms so our QC techs can just scan the results into the room and save considerable amounts of time.

 

We are hung up on the whole electronic record part 11 scenario.  Half of our group thinks the scanned file is an electronic record subject to part 11, and half think its just like a copy.

 

Any thoughts?



#2 mgourley

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Posted 27 March 2017 - 07:21 PM

Here is the FDA Guidance Document

 

Marshall



#3 Slab

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Posted 27 March 2017 - 07:30 PM

Hi, jgantomasso;

 

Copies of records do fall under regulatory jurisdiction depending on the use of the document. Is the copied document retained by you as a record or is the QC form 'terminal', meaning it is discarded in a prescribed manner after use? Myself, I would not allow this practice. Investigations would require a chain of custody of the document as it's issued. If it's required at a CP or CCP then it falls under the code. 

 

 

4. Copies of Records
 
The Agency intends to exercise enforcement discretion with regard to specific part 11
requirements for generating copies of records (§ 11.10 (b) and any corresponding requirement in
§11.30). You should provide an investigator with reasonable and useful access to records during
an inspection. All records held by you are subject to inspection in accordance with predicate
rules (e.g., §§ 211.180©, (d), and 108.35©(3)(ii)).

 

 


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#4 jgantomasso

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Posted 27 March 2017 - 08:21 PM

Well I guess there isn't a paper copy, it is a scan that the people in the cleanroom would use to get their data. 



#5 Ryan M.

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Posted 28 March 2017 - 11:48 PM

I wouldn't call it a copy.  Put it on a network share drive so people can access it and restrict the access to the files to appropriate persons at appropriate levels.  You can restrict people from copying the file, deleting the file, and modifying the file.






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