Draft Guidance Now Available for Electronic Copies.  FDA Accepting Comments Until February 10, 2003.

 The main practices and principles defined in this guidance concern the making of electronic copies of electronic records.  It explains the characteristics they should have and answers “frequently asked questions”.


The notice of the guidance was posted in the November 12th issue of the Federal Register, and covers all aspects of providing the FDA with electronic copies of electronic records that are “accurate, complete, and suitable for FDA inspection, review, and copying” as stipulated by 21 CFR Part 11.


In the draft guidance (67FR68674), discussing the key principles and practices the FDA lays out the following points:  electronic copies do not have to be in the same file format and on the same media as electronic records; if the format differs, the process for making the copy must be validated; and if hyperlinked records are referred to, they must be included with the electronic copy of the records.


The draft guidance also includes the following information:  When appropriate, electronic copies of database queries must be part of the copies; electronic copies must have an authentication value either in the body or as an appendix; the electronic copies must be in a file format and on media that the FDA can read, process and record;  if the original records are signed electronically, then the copies must have electronic signatures that can be authenticated.


More information can be obtained from the FDA web site: