GCP Computerized Systems

urvikraj

Registered
Hi!
Which is the latest FDA guidance for computerized systems used in GCP Clinical Trials?

This: Guidance for Industry - COMPUTERIZED SYSTEMS USED IN CLINICAL TRIALS: (1999)
Or This: Guidance for Industry Computerized Systems Used in Clinical Investigations (2007)


I guess its not clear that that 2007 guidance supersedes the 1999 once, because of the difference in their titles.
 

yodon

Leader
Super Moderator
Interestingly, the landing page for the 2007 guidance has this note:

This guidance supersedes the guidance of the same name dated April 1999...

The 1999 guidance was issued in April 1999, but as you point out, the names are not the same. A guidance search on "computerized" does not show the April 99 doc so it at least has been superseded.
 
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