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The FDA recently released a draft guidance on electronic records maintenance.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