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At the beginning of November, FDA published the fifth Draft Guidance on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As usual, this Draft Guidance was released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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