Electronic signature on several documents simultaneously

COMPUTER SYSTEM VALIDATION (CSV) 21 CFR PART 11
1

Dear all,

I was asked recently by my manager to provide a support from the CSV perspective for the business request to have one electronic signature when a user need to sign on more then two documents, each of the documents should include an electronic signature as a stand alone document but the signing process will only appear once for an unlimited number of documents.

My “CSV spirit” was just about to automatically said it is forbidden but I can’t find any regulatory request to support my thought.

Any possible help will be most welcome.

Scotti

2

Since you posted in the Part 11 forum, I presume these signings would fall under that scope.

While not explicitly prohibited, it pushes the limits of 11.50(a)(3), 11.70 (the “copied” aspect), and 11.200(a)(1)(i). If you can clearly show that the spirit of these is upheld, you may be ok. I would not want to try to defend it.