2004N-0133 - Part 11 Public Meeting; June 11, 2004
FDA Comment Number : EC13
Submitter : Mr. Zitoun Philippe Date & Time: 06/10/2004 04:06:05
Organization : NOTOCORD Systems
Private Industry
Category :
Issue Areas/Comments
GENERAL
GENERAL
In section 11.10 (a), what 'ability to discern invalied or altered records' exactly mean? When we have to deal with a database, does an invalid record mean a field where some data are changed with a wrong value? When we have a signal collected through an analog to digital converter, does it mean the signal is noisy? Does altered mean changed by someone or simply changed by a validated process? Does invalid means the signal has been changed by someone and not anymore correct?