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.
