From: Thomas Quinn [tquinn@hollisgroup.com] Sent: Friday, October 04, 2002 4:52 PM To: fdadockets@oc.fda.gov Cc: Paul Motise; Barbara Meserve; Russ Madsen Subject: Submission for Docket 00D-1539 Sirs, Please accept the attached article as a submission for docket 00D-1536, Electronic Records & Electronic Signatures, Retention of Electronic Records. PDA and I hereby grant FDA an unlimited right to copy and distribute the work, or any portion thereof, as long as the attributions to PDA and the original author (T.Quinn) are included in and prominently displayed upon such copies or distributions. Thank you. Sincerely, Thomas Quinn, CISSP, AAA President, The Hollis Group, Inc. tquinn@hollisgroup.com v: 610-889-7350 f: 610-296-2339 "More freedom there, not less freedom here!" tquinn(c)20010911 This message is copyrighted tquinn(c)2002 ----- Original Message ----- From: Russell E. MADSEN To: 'Thomas Quinn' Sent: Friday, October 04, 2002 11:50 AM Subject: RE: e-Archiving Article Thomas, PDA hereby grants permission to you to submit the attached article, "Archiving Requirements for Pharmaceutical Manufacturing Documents and Associated Executable Software," which appeared in the PDA Journal of Pharmaceutical Science and Technology, Vol. 48, No. 6. (NOV / DEC 1994), to the FDA Docket 00D-1539. Russell Madsen Acting President PDA -----Original Message----- From: Thomas Quinn [mailto:tquinn@hollisgroup.com] Sent: Friday, October 04, 2002 11:35 AM To: Russ Madsen Subject: e-Archiving Article Russ, The FDA recently released a draft guidance on electronic records maintenance. "Maintenance" is the FDA view of what the rest of us know as "Archiving." In this guidance, FDA makes no mention of the viewer / emulator method for archive retrieval. This is a serious oversight on FDA's part, and industry needs to inform FDA of the cost and reliability advantages of this method over the "migrate forever" method they seem to prefer. My article in "Archiving Requirements for Pharmaceutical Manufacturing Documents and Associated Executable Software," which appeared in the PDA Journal of Pharmaceutical Science and Technology, Vol. 48, No. 6. (NOV / DEC 1994), includes my earliest thinking on the subject, and would be of value to include in FDA's docket. Could you, please, forward a copy of the article to the FDA Docket on the subject: 00D-1539: Electronic Records &Electronic Signatures, Retention of Electronic Records at http://www.fda.gov/ohrms/dockets/dockets/00d1539/1.htm If you think it would be more appropriate for me to submit it as the original author, please feel free to send me a copy, and I will post it. Thanks you for your assistance. Sincerely, Thomas Quinn, CISSP, AAA President, The Hollis Group, Inc. tquinn@hollisgroup.com v: 610-889-7350 f: 610-296-2339 "More freedom there, not less freedom here!" tquinn(c)20010911 This message is copyrighted tquinn(c)2002