FDA's New Draft Guidance on Electronic Copies of Electronic Records

GMP News No. 261

GMP News
13 November 2002

FDA's New Draft Guidance on
Electronic Copies of Electronic Records

At the beginning of November, FDA published the fifth Draft Guidance onPart 11. This Draft describes FDA's current thinking on the way in whichelectronic copies of electronic records should be made.

This Guidance regulates Part-11-conformmethods for generating electronic copies of electronic records that areprovided by the industry to FDA for review and inspection purposes. Thefollowing 7 requirements are laid down:

  • Electronic copies of electronicrecords provided to FDA should be accurate and complete, but they donot necessarily have to be in the same file format and on the samemedia as the original electronic records.
  • The process of making an electroniccopy of an electronic record in a file format that differs from theoriginal should be validated.
  • Copies of hyperlinked recordsincorporated by reference should be included with the electronic copyof the electronic record.
  • Electronic copies of databasequeries should be included with electronic copies of electronicrecords, when appropriate.
  • Electronic copies of electronicrecords should include, or be appended with, an authentication value.
  • Electronic copies of electronicrecords should be in a file format and on media that enable FDA toread and process record data.
  • If original electronic records weresigned electronically, electronic copies of the original electronicrecords should have electronic signatures that are capable of beingauthenticated.

This document fills a regulatory gapconcerning the provision of copies of quality-relevant electronic recordsto FDA for inspection purposes. In establishing these rules, it intends toensure the loss-free transfer of electronic information.

As usual, this Draft Guidance was releasedfor commenting by the industry within 90 days of publication.


Dr Gerhard Becker

The Draft can be downloaded directly viathis link:


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