Pharamaceutical Industry & Life Sciences

 







21 cfr part 11 guidelines:


SUBPART A – GENERAL PROVISIONS

Scope

Implementation

Definitions


SUBPART B – ELECTRONIC RECORDS 

 Controls for closed systems 

 Controls for open systems 

Signature manifestations 

Signature/record linking 


SUBPART C – ELECTRONIC SIGNATURES  


 General requirements 

Electronic signature components  

and controls

Controls for identification  

codes/passwords

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