Anoyone else heard the FDA might recall CFRpt11? - FDA.COMs Community Forums

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Post: Anoyone else heard the FDA might recall CFRpt11? (Topic#403)

Anonymous

08-19-03 04:19 AM - Post#403

I've heard it may be recalled as impractical. Any truth to this or anyone else heard anything similar? thx

John
John Cuspilich, Sr. Consultant
Posts: 229
John

08-19-03 08:12 AM - Post#404

In response to Anonymous

No, Part 11 at this time is not being recalled.
There is a 'risk' based initiative being discussed which would only change the scope of the Part 11 regulations, however, at this time, the only draft guidance document that discussed the initiative was withdrawn.
For further information see:
http://www.fda.gov/cder/gmp/index.htm
http://www.fda.gov/OHRMS/DOCKETS/98fr/03-4312.pdf
http://www.fda.gov/OHRMS/DOCKETS/98fr/03d-0060-gdl0001.PDF
http://www.fda.gov/cber/gdlns/prt11elect.htm

Sincerely,
John F. Cuspilich, Sr. Consultant RA/QA
FDA.COM
The Auditing Group, Inc.
GMP Publications, Inc.
jcuspilich@auditing.com
jcuspilich@fda.com
856-596-2333 - 866-GXPNews

Anonymous

11-23-04 03:04 AM - Post#1222

In response to Anonymous

Over the summer, a coalition spearheaded by PHARMA submitted a petition to the FDA requesting that Part 11 be revoked. The argument is that there was legislation passed in 1998 (the year after Part 11) applying to the entire federal government that addresses electronic signatures, and this legislation should be the governing regulation, not Part 11.

Haven't heard any further word. You can track down the petition on the FDA web site.