Final Electronic Systems/records/Signatures Q&A released by FDA yesterday

Yesterday, FDA released a Final Guidance "Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations Questions and Answers Guidance for Industry" (Revision 1).

This guidance finalizes the Draft Guidance of the same title issued on 16Mar23 (Also Revision 1).

If you are familiar with the last year draft, here a few high level comments:

• Guidance is reduced from 32 pages to 28.
• Chapter B was renamed and examples of electronic systems were removed
• Question 7 with largely revised (including UAT topic). Question 9, 11 & 23 were also revised
• Question 8 was expanded. Question 23 E. Electronic Signatures was expanded a bit.
• Question 18 was rephrased
• Question 29 (Are users of electronic signatures required to submit letters of non-repudiation to FDA to certify that an electronic signature is the legally binding equivalent of a traditional handwritten signature?) was added.

Finally,

• the 34 terms Glossary was reduced to 7 terms :-(
• the Appendix was expanded a bit

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/electronic-systems-electronic-records-and-electronic-signatures-clinical-investigations-questions