Q: In the case where an original record was paper-based (with signatures, etc.), will the FDA accept an electronic representation of that paper document?
Some of our documents have wet ink signatures that we scan and then retain the electronic record while discarding the original paper. Is this acceptable?
A: Yes, FDA will accept the electronic version of the original complete record that was paper-based (with signatures, etc.) as long as it is 1) a true copy, 2) legible, 3) complete, and 4) you can show the electronic record has not been altered or changed after it was copied into the electronic version.
[pullquote align=”right” cite=”” link=”” color=”” class=”” size=””]You must be able to show the electronic record has not been altered or changed.[/pullquote]
Even before Part 11 was issued, FDA allowed companies to scan and archive paper records as microfiche and destroy the original paper records, so the same principle applies.
Answered by Janis Olson, Vice President of Regulatory & Quality Services at EduQuest (22 years as an expert FDA investigator and as the FDA regional director of information management resources).
Jan also is the co-instructor of EduQuest’s FDA Auditing of Computerized Systems and Part 11/Annex 11 training class.