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Transformation into paperless records and electronic signatures?


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#1 FSPORG

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Posted 30 March 2017 - 01:18 PM

Hello all, 

 

I am looking for a little help. In an effort to save money and space and time, our facility is looking to move forward being paperless. The departments making this change will be our production and QA.  We are SQF level 3 and when we mentioned this to our auditor last year they welcomed it. However, we are now seeing many regulations with the FDA over paperless records, specifically being "electronic signatures."  If anyone has any input or has experienced this recently, could they please provide as much information as to their transformation into paperless records and electronic signatures?

 

Also, currently have a software program that saves our records and does not let them be altered in any way once they are submitted.

 

Thanks in advance! 


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#2 Ryan M.

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Posted 05 April 2017 - 02:48 PM

We are almost completely paperless when it comes to inspections and audits.  We have lots of paper records we still use for production, but only for production and not any other functional area.  The security of our records is through Adobe PDF.  When you scan a record that was in paper format it becomes unalterable in Adobe PDF.  Yes...if someone was really sneaky they could theoretically use the OCR function and edit, but Adobe doesn't do well with this when it comes to handwritten records.  So far it has not been an issue.

 

Documents, and soft copies of electronic records can be secured with Adobe PDF using the secure function after converting to PDF.  You can apply security to documents being converted to Adobe PDF where they are unalterable and can only be printed.  It even goes as far as not allowing persons to highlight and copy the text.

 

The other avenue of security with records, if you use microsoft excel, is to secure the worksheet under the review tab.  You can place security for each worksheet in a workbook and apply a password so the data cannot be altered.

 

These are cheap and easy ways to secure your records.  I hope it helps.  I have found the biggest hindrance or helpfulness with this is having one point person, with one backup, secure everything.  I don't know if this is feasible for your facility and process, but it was for us, we started small so it was relatively easy to implement from the get go.


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#3 FurFarmandFork

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Posted 06 April 2017 - 06:20 PM

Ryan makes a great point about keeping it simple.

 

Keep in mind, if you are having signatures that aren't scanned, but are truly electronic, you need to notify your FDA regional office of any primary records that have an impact on food safety that are ONLY signed electronically. It's much easier if the primary production documents as in Ryan's case above (with CCP checks etc.) start off on paper and still contain handwritten signatures.


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#4 Ryan M.

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Posted 06 April 2017 - 11:04 PM

Ryan makes a great point about keeping it simple.
 
Keep in mind, if you are having signatures that aren't scanned, but are truly electronic, you need to notify your FDA regional office of any primary records that have an impact on food safety that are ONLY signed electronically. It's much easier if the primary production documents as in Ryan's case above (with CCP checks etc.) start off on paper and still contain handwritten signatures.


I haven't heard that requirement...and it seems like something that can be interpreted differently depending on your inspector/auditor. To clarify, what record is interpreted as having an impact on food safety.

Do you have the FDA regulatory reference for this?

Thank you.
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#5 FSPORG

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Posted 07 April 2017 - 11:03 AM

Thank you for the responses. We have read the FDAs code of compliance with the electronic signatures. It does state in the rule that the FDA needs to have on file, the signatures of personnel signing the electronic document. 


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#6 FurFarmandFork

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Posted 10 April 2017 - 01:41 PM

I haven't heard that requirement...and it seems like something that can be interpreted differently depending on your inspector/auditor. To clarify, what record is interpreted as having an impact on food safety.

Do you have the FDA regulatory reference for this?

Thank you.

Hi Ryan,

 

It's covered in 21 CFR 11.1, and there's additional guidance here.

 

"it seems like something that can be interpreted differently depending on your inspector/auditor."

Well, yes. It's FDA after all, they don't provide guidance, only findings :)

 

Key points from the CFR and guidance relevant to this discussion:

"However, this part does not apply to paper records that are, or have been, transmitted by electronic means."

Scanned documents are therefore not considered an "electronic record" subject to these requirements.

 

when persons use computers to generate paper printouts of electronic records, and those paper records 168 meet all the requirements of the applicable predicate rules and persons rely on the paper records to perform their regulated activities, FDA would generally not consider persons to be "using electronic records in lieu of paper records"

E.g. master copies, forms, and databases for which you print out a paper record are not subject to the rule.

 

"This part does not apply to records required to be established or maintained by part 117 of this chapter. Records that satisfy the requirements of part 117 of this chapter, but that also are required under other applicable statutory provisions or regulations, remain subject to this part."

GMP records are omitted unless they satisfy some other requirement (e.g. HACCP records)

 

 Persons using electronic signatures shall, prior to or at the time of such use, certify to the agency that the electronic signatures in their system, used on or after August 20, 1997, are intended to be the legally binding equivalent of traditional handwritten signatures.

 forms,And from one of the guidance documents:

ORO’s agency-wide responsibility for certification documents is cited in 21 CFR 11.100© which says, persons using electronic signatures shall, prior to or at the time of such use, certify to the agency that the electronic signatures in their system, used on or after August 20, 1997, are intended to be the legally binding equivalent of traditional handwritten signatures. 21 CFR 11.100©(1) states the certification shall be submitted in paper form and signed with a traditional handwritten signature, to the Office of Regional Operations (HFC-100).

 

I've been preparing my letter for a while now, I'll be sure to let IFSQN know if I get any interesting feedback from FDA.


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#7 FSPORG

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Posted 11 April 2017 - 01:27 PM

Thank you all again for the responses.

 

Have any of you sent in a letter to the FDA saying you are now going paperless and will now have electronic signatures. This comes from 11.100 (1) 

this states: (1) The certification shall be submitted in paper form and signed with a traditional handwritten signature, to the Office of Regional Operations (HFC-100), 5600 Fishers Lane, Rockville, MD 20857.


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#8 Ryan M.

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Posted 11 April 2017 - 03:16 PM

Hi Ryan,

 

It's covered in 21 CFR 11.1, and there's additional guidance here.

 

 

 

Perfect, thank you!


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