21 CFR Part 11

Part 11 is the part of 21 CFR that deals with electronic records & electronic signatures.

• True
• False

Main purpose of 21 CFR part 11 is,

• To reduce the risk of, records being deliberately manipulated to falsify results.
• To prevent unauthorized access to data.
• To ensure trace ability of records to their originator or owner.
• All of the above

Validation should include application-specific functions as well as functions related to Part 11, electronic audit trail and electronic signatures

• True
• False

As per Part 11, the procedures are not require to limit the access to authorized users

• True
• False

Part 11 must be applied to keep electronic records even it is older than 1997

• True
• False

If you use a computer system to satisfy any predicate rule requirement – 21 CFR Part 11 will apply

• True
• False

Email software and Microsoft office are the best example of Open system

• False
• True

Each electronic signature shall be unique to one individual and shall be reused by, or reassigned to, anyone else.

• True
• False

E-Signature is legally binding

• True
• False

Audit Trail Records needs to include 

• Date & Time Stamp
• Node of Origination
• Operator Name
• All of the above