: Security measures to ensure that only authorized individuals can access or alter records. Managing .rar Files
: Secure, computer-generated, time-stamped records that track all changes to electronic data without obscuring previous entries.
: Guidance on how to handle systems operational before August 1997, where the FDA may exercise enforcement discretion.
: Documented proof that a system performs consistently and as intended.
In a regulatory or compliance context, "Part 11" refers to the criteria under which the FDA considers electronic records and signatures to be trustworthy, reliable, and equivalent to paper records. Key requirements typically covered in such reports include:
