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?
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.