Welcome to Title 21 CFR part 11 trivia questions on FDA guidance for industry! This code is designed to cover digital signatures and, generally, extend its oversight to IT, software and the digital world. The code has been widely misunderstood, and some say, misapplied by pharma companies. Take the quiz and see if you are in the list of people who understand the code.
August 1997
March 1997
April 2001
January 1999
The IT department
The people responsible for the content
Users
Nobody
People responsible for the content
The IT department
Nobody
Users
Validation of computer systems
Controls for open systems
Controls for closed systems
All of the above
The printed name of the signer
The date and time when the signature was executed
The meaning (such as review, approval, responsibility or authorship) associated with the signature
All of the above
Validation of systems
Electronic signatures
There are no controls
BIometrics
ERP system on the Intranet
Internet
Intranet
QMS on the Intranet
Internet
Intranet
LMS on the Intranet
B and c
Education
An electronic signature
Training
Both a and c
Biometrics
Document encryption
Electronic signatures
There are no additional measures to be conducted
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