Modification to Change Control Module
Having seen the demonstration of the new Change Control module ti lacks some functionality with respect to CFR Part 11 and Electronic Signatures.
To be compliant with these FDA guidelines users should be prompted for their password when approving changes for example rather than assuming the person currently logged in is the person that the action has been assigned to. Positive authentication is required at this stage.
To be compliant with these FDA guidelines users should be prompted for their password when approving changes for example rather than assuming the person currently logged in is the person that the action has been assigned to. Positive authentication is required at this stage.