: Secure, computer-generated, time-stamped records that track all changes to electronic data without obscuring previous entries.
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:
: Documented proof that a system performs consistently and as intended.
: Secure, computer-generated, time-stamped records that track all changes to electronic data without obscuring previous entries.
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:
: Documented proof that a system performs consistently and as intended.
