From: Henig, Anne M
Sent: Wednesday, May 12, 2004 11:03 AM
To: 'Derek Wimmer'; Dockets, FDA
Subject: RE: Docket No. 2004N-0133
Mr. Wimmer,
  Once registration is complete (close of business on May 12, 2004) and I can determine how many individuals want to present, I will alert you as to how much time you will be allocated to make your presentation.  You should receive confirmation from me within the next week.  Thank you. 
 
Anne M. Henig
FDA/Center for Drug Evaluation and Research
Executive Operations Staff
301-443-5576
heniga@cder.fda.gov
-----Original Message-----
From: Derek Wimmer [mailto:derek.wimmer@wimmersystems.com]
Sent: Monday, May 10, 2004 11:40 AM
To: fdadockets@oc.fda.gov
Cc: heniga@cder.fda.gov
Subject: Re: Docket No. 2004N-0133

To Whom It May Concern:
 
Good morning. I never heard back on this request to speak, which will also include new approaches for secure and authenticatable printed electronic signatures. Could you please confirm, or will the list be decided after submission of abstracts? Thank you for your time.
 
best regards,
 
Derek Wimmer
President
Wimmer Systems, Inc.
P.O. Box 739
Liberty, Missouri 64069
Tel/Fax 1-800-795-3227
Mobile 816-728-2387
http://www.wimmersystems.com
----- Original Message -----
From: Derek Wimmer
To: fdadockets@oc.fda.gov
Cc: heniga@cder.fda.gov
Sent: Thursday, April 08, 2004 9:54 AM
Subject: Docket No. 2004N-0133

I would like to request a speaking slot at the June 11,2004 meeting regarding 21 CFR 11. Please respond with confirmation of registration, or if I need to send this message to another party.
 
1. Specific issue I intend to address:
What requirements would preserve record security and integrity and ensure that records are suitable for inspection, review, and copying by the agency?
 
2. Presenter:
Derek Wimmer
President
Wimmer Systems, LLC
P.O. Box 739
Liberty, Missouri 64069
3. Abstract
Record security and integrity can be acheived by using cryptographic tools that have been widely and freely available since the final rule. Requiring appropriate cryptographic methods to ensure record security and integrity would not place an undue burden on industry. As a matter of fact, such methods have been routinely used in commercial applications for years. For illustration, an existing Part-11 compliance product utilizing such methods will be discussed, along with how cryptographic methods can be used to ensure record security and integrity, as well as supporting electronic signatures.
 
Presentation time: 15 minutes (30 minutes if time is available)
 
Thank you for your consideration.
 
Best regards,
 
Derek Wimmer
President
Wimmer Systems, LLC
P.O. Box 739
Liberty, Missouri 64069
Tel/Fax 1-800-795-3227
Mobile 816-728-2387
http://www.wimmersystems.com