There have been a number of FDA warning letters raised against spreadsheets. See a summary of those warning letters here.
The majority of warning letters have been raised against the spreadsheets not being validated, rather than any specific security concerns. Of course the problem is that is difficult or impossible to validate a spreadsheet with native Excel, and therefore you require DaCS™ to allow you to validate successfully. For further information on the technical issues and justifications for validating spreadsheet see here.
Spreadsheet related warning letters.
Earlham Analytical Laboratories, July 29, 2002
Cardinal Health, Inc. July 10, 2001
Medical Industrial Equipment Ltd. June 8, 2000
Apheresis Technologies, Inc, Nov 12 1999
Drager Medizintechnik GmbH, Aug 6, 1999
B. Braun Medical Inc, April 29, 1999
Willis Eye Associates. July 7, 1998
