Science Content

21 CFR Part 11 (11.200a)

Be administered and executed to ensure that attempted use of an individual’s electronic signature by anyone other than its genuine owner requires collaboration of two or more individuals.

System ensures the items apply to electronic signatures that are not based upon biometrics

Employ at least 2 distinct identification components such as ID code & password

The system can only be used by their genuine owners

21 CFR Part 11 (11.30a)

Company must employ use of digital signatures for record authenticity and integrity

21 CFR Part 11 (11.10b)

Company must generate accurate & complete copies of records in both human readable & electronic form suitable for inspection, review, and copying

21 CFR Part 11 (11.100b)

Company must ensure that individual identity will be verified before a signature

21 CFR Part 11 (11.10d)

The system must be able to limit system access to authorized individuals

21 CFR Part 11 (11.10e)

Ensure that record changes do not obscure previously recorded information

21 CFR Part 11 (11.10g)

The system must employ the use of authority checks to ensure that only authorized individuals use the system