2003D-0060 - Guidance for Industry on Part 11, Electronic Records; Electronic Signatures--Scope and Application Availability

  


  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC30
  



  

  

  



  

  
Submitter : 
  

  
Mr. Patrick  Chiu
  

  
Date & Time: 
  

  
06/10/2004 05:06:16
  



  

  
Organization : 
  

  
Aslan Consulting Services, LLC
  



  

  
Drug Industry
  


  

  
Category : 
  


  

  
Issue Areas/Comments 
  


  

  



  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 If one can just spend some time to read and understand the preambles, one would decide that the current guidance document is fair and flexible. The overall Part 11 approach is consistent with other predicate rules..in a nut shell: to spend time and understand the system, challenge to system according to the user requirements, design specs, and take the time to document the test results, and investigate/justify deviations.  Perform a good computerized system validation and part 11 is automatically covered.