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?