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What are the requirements for electronic records under FSMA?


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#1 silviakahn

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Posted 21 September 2017 - 09:09 PM

Does someone know what are the requirements for electronic records under FSMA?

 

Thank you,

 

Silvia


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#2 Peaches

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Posted 28 September 2017 - 02:28 PM

Electronic copies must comply with 21 CFR 11

  • Signatures must be authenticated
  • Validated controls must be in place to ensure electronic signatures and electronic records can be relied upon in the same manner as paper records and pen & ink signatures. Applies also to handwritten signatures affixed to electronic records.

 

From what I understand, electronic records must be controlled and signatures have to be authentic and be able to be validated.  So you can't have one log in and have 3 different people recording information on that same record - somehow there has to control of the record to show that no one else had access except that user. 


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#3 GrainGirl

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Posted 28 September 2017 - 03:35 PM

Section 117.305(g) of the Preventive Controls for Human Food (PCHF) Rule under FSMA actually explicitly exempts records from meeting the electronic recordkeeping requirements under 21 CFR Part 11:

 

"Records that are established or maintained to satisfy the requirements of this part and that meet the definition of electronic records in section 11.3(b)(6) of this chapter are exempt from the requirements of part 11 of this chapter. Records that satisfy the requirements of this part, but that also are required under other applicable statutory provisions or regulations, remain subject to part 11 of this chapter."

 

So unless the records are required under some other law or regulations, records kept pursuant to the PCHF Rule are exempt from the fairly onerous electronic recordkeeping requirements of 21 CFR Part 11.

 

That said, there is still the question of what will satisfy as a "signature" on an electronic record under the PCHF Rule. We submitted that very question to the FDA's Technical Assistance Network (TAN) several months ago. I will post the answer if and when we hear back from the FDA.


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#4 silviakahn

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Posted 28 September 2017 - 05:58 PM

Thank you for their replies. 

 

GrainGirl: I had also read the same exemption for both the Preventive Control and the Foreign Supplier Verification rules. I also submitted the same question to the assistance network last Friday. When I get news from FDA, I will post my answer as well. I am not very optimistic though. I submitted a question regarding the FSVP in March, and I am still waiting. 


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#5 GrainGirl

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Posted 29 September 2017 - 05:01 PM

In a stroke of good timing, we just received our reply from FDA on this issue.

 

Here is the question we posed:

 

Some of our documents are maintained exclusively electronically and we want to ensure compliance with the part 117 requirement that records include the signature or initials of the person performing the activity (117.305(f)(3)). Section 117.305(g) exempts electronic records solely established or maintained to satisfy part 117 from the requirements of part 11. We read 117.305(g) to mean that we do not have to follow the electronic signature requirements of part 11, but it is unclear to us what IS acceptable as a signature or initials on an electronic document under part 117 besides signatures that meet the requirements under part 11. 

Thus, our question is: What form of signature is acceptable on electronic records under part 117 in lieu of signatures that meet part 11 requirements? Some examples might be: 1) typed signature or initials, 2) an image of a written signature or initials that is inserted into an electronic document, 3) signing with a stylus (limited to tablet-style devices) or 4) printing an electronic document, signing manually, and scanning the document as a pdf. The latter option defeats the purpose of maintaining electronic records, and we are hoping that the FDA will accept some or all of the first three options. Thank you for any guidance you can provide. 

 

 

 

And here is FDA's response:

 

The Food and Drug Administration’s (FDA) Food and Cosmetic Information Center (FCIC)/Technical Assistance Network (TAN) has prepared a response for case number 00128562. 

 

Response: Good morning and thank you for your inquiry.
The Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food final rule
 (21 CFR part 117
; 80 FR 55908) (CGMP & PC rule) provides in 21 CFR § 117.305(g) that records that are established or maintained to satisfy the requirements of part 117 and that meet the definition of electronic records in 21 CFR § 11.3(b)(6) are exempt from the requirements of 21 CFR part 11.  This is discussed inResponse 638 of the CGMP & PC rule (see 80 Fed. Reg. 55908 at 56088).  As noted, facilities should take appropriate measures to ensure that records are trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.  The types of signatures on electronic records cited in the inquiry would be considered acceptable provided the signature or initials are accurate, indelible, and legible (see 21 CFR 117.305©).  
  

 

Of course FDA caveats that the response is not an advisory opinion. They also state that the communication is for the exclusive use of the inquirer, so I guess I shouldn't be posting it, but I said I would and it seems ludicrous that this kind of information shouldn't be shared. 


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#6 silviakahn

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Posted 29 September 2017 - 05:38 PM

Thank you so much for posting your answer.  :spoton:

 

It is good to know that FDA is open to accept all those forms of electronic records/signatures. However, I am a little bit concern with the part that says that they are considered acceptable "provided the signature or initials are accurate, indelible, and legible". 

 

I wish they publish a guidance with that information in the future and specific examples. 


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