FDA's New Draft Guidance on Electronic Copies of Electronic Records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FDA's New Draft Guidance on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At the beginning of November, FDA published the fifth Draft Guidance on Part 11. This Draft describes FDA's current thinking on the way in which electronic copies of electronic records should be made.

This Guidance regulates Part-11-conform methods for generating electronic copies of electronic records that are provided by the industry to FDA for review and inspection purposes. The following 7 requirements are laid down:

  • Electronic copies of electronic records provided to FDA should be accurate and complete, but they do not necessarily have to be in the same file format and on the same media as the original electronic records.
  • The process of making an electronic copy of an electronic record in a file format that differs from the original should be validated.
  • Copies of hyperlinked records incorporated by reference should be included with the electronic copy of the electronic record.
  • Electronic copies of database queries should be included with electronic copies of electronic records, when appropriate.
  • Electronic copies of electronic records should include, or be appended with, an authentication value.
  • Electronic copies of electronic records should be in a file format and on media that enable FDA to read and process record data.
  • If original electronic records were signed electronically, electronic copies of the original electronic records should have electronic signatures that are capable of being authenticated.
    •

    This document fills a regulatory gap concerning the provision of copies of quality-relevant electronic records to FDA for inspection purposes. In establishing these rules, it intends to ensure the loss-free transfer of electronic information.

    As usual, this Draft Guidance was released for commenting by the industry within 90 days of publication.

    In this context, we would like to draw your attention to the following events:

    Aut

    hor:
    Dr Gerhard Becker
    CONCEPT HEIDELBERG

    The Draft can be downloaded directly via this link:
    http://www.fda.gov/OHRMS/DOCKETS/98fr/00d-1540-gdl0001.pdf 
       

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