From: Gordon B. Richman [GordonBRichman@EduQuest.net] Sent: Thursday, July 08, 2004 5:42 PM To: fdadockets@oc.fda.gov Cc: Martin Browning Subject: [Docket No. 2004N-0133] -- EduQuest Comments on FDA's Part 11 Re-examination Importance: High To Whom It May Concern -- EduQuest, Inc. respectfully submits the attached written comments in response to FDA's April 8, 2004 Federal Register notice (69 Fed. Reg. 18,591) concerning the ongoing re-examination of the 21 CFR Part 11 regulation on electronic records and electronic signatures. Please note that a signed copy of the document was faxed to FDA at 301-827-6870 in the last 45 minutes. Please let me know if all 20 pages (including the fax cover sheet) were not received. Gordon B. Richman Vice President, Strategic Compliance Consulting and General Counsel EduQuest, Inc. 1896 Urbana Pike, Suite 14 Hyattstown, Maryland 20871 Tel: 301-874-6031 Fax: 301-874-6033