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Go Back   The Elsmar Cove Forum > Medical Devices, Medical Information Technology, Medical Software and Health Informatics > Medical Device Related Regulations > US Medical Device Regulations > 21 CFR Part 820 - US FDA Quality System Regulations (QSR)
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FDA Rules and Requirements for Keeping Ink Signed Documents

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  Post Number #1  
Old 27th April 2012, 04:35 PM
ryno fan

 
 
Total Posts: 34
Please Help! FDA Rules and Requirements for Keeping Ink Signed Documents

Hello,

I work at an FDA-regulated software medical device manufacturer.

Due to the cost of storage space for paper documents, we want to move towards scanning all original ink-signed copies so we can store records electronically. Do we, by law or regulation, have to keep the actual ink-signed paper copy? Is it permissible to discard the ink-signed copy if we have a scan of it?

Thanks

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  Post Number #2  
Old 27th April 2012, 07:02 PM
Ajit Basrur's Avatar
Ajit Basrur

 
 
Total Posts: 5,737
Look! Re: FDA Rules for Keeping Ink Signed Documents

This is a great question

In fact, when I worked at Pharmaceuticals, we used to scan all the paper documents as backups and to mitigate the risk of loos / damage of hard copies.
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  Post Number #3  
Old 27th April 2012, 07:40 PM
Marc's Avatar
Marc

 
 
Total Posts: 24,472
Re: FDA Rules for Keeping Ink Signed Documents

Ajit - So you kept the paper copy and the scanned copy?
  Post Number #4  
Old 27th April 2012, 07:47 PM
Ajit Basrur's Avatar
Ajit Basrur

 
 
Total Posts: 5,737
Re: FDA Rules for Keeping Ink Signed Documents

Quote:
In Reply to Parent Post by Marc View Post

Ajit - So you kept the paper copy and the scanned copy?
Yes Marc
  Post Number #5  
Old 27th April 2012, 08:15 PM
MIREGMGR

 
 
Total Posts: 3,416
Re: FDA Rules and Requirements for Keeping Ink Signed Documents

Ryno, are you familiar with 21 CFR 11?

Those rules have had an on-off-on-off enforcement history since they were first put forth. As far as I know, though, they still represent FDA's thinking as to the Gold Standard for document control and authorization/responsibility proof.
Thanks to MIREGMGR for your informative Post and/or Attachment!
  Post Number #6  
Old 28th April 2012, 04:12 AM
Gert Sorensen's Avatar
Gert Sorensen

 
 
Total Posts: 1,266
Re: FDA Rules and Requirements for Keeping Ink Signed Documents

If you validate your server in accordance with Part 11, and you validate your scanning process to ensure that you actually have trustworthy scans then the FDA accepts that you only retain the scanned document. This has been accepted since the days of the microfiche technology. Just remember that you have to have solid documentation that substantiates your claim that the system/process is validated for this use.

  Post Number #7  
Old 30th April 2012, 09:38 AM
jradford

 
 
Total Posts: 49
Re: FDA Rules and Requirements for Keeping Ink Signed Documents

The servers I can understand. Retention and backup procedures. How do you qualify a scanner? Check legibility against the original signature? Does anyone have a process for this?
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