21 CFR Part 11

Title 21 CFR Part 11 (or Part 11 as it is commonly known) deals with the FDA guidelines on electronic records and electronic signatures. It requires FDA regulated industries to implement auditing, system validation, document audit trails, and electronic signatures. In this introduction to 21 CFR Part 11 we shall deal with the case for electronic signatures and electronic security.

iPassport assists you to demonstrate the requirements for electronic signatures required within 21 CFR Part 11 have been met, iPassports has a requirement not only for the user to log into the system using a username and password but in addition a personal identification number (PIN) when issuing an electronic signature for a controlled document, both the password and PIN are encrypted and known only to the user. With these controls iPassport to be declared compliant with the technical requirements of 21 CFR Part 11 and thus iPassport helps you become fully compliant with 21 CFR Part 11.

Security controls within iPassport include the option for the administrator to set password parameters, this tool allows for the setting of minimum password length and password expiration, in addition to this iPassport can also restrict what users can reset passwords and within all information logged within the changelog for each user you can be sure that the technical requirements for 21 CFR Part 11 have been met.

For added security iPassport offers a user inactivity timeout option, so that should a user forget to log out of the system iPassport shall log them out and lock access to iPassport from that terminal all of which helps you to demonstrate compliance to 21 CFR Part 11.