This document discusses the 1997 FDA ruling 21 CFR Part 11 and its impact on the pharmaceutical industry. It also describes the compliance features of the LC/MSD Trap Security Pack 1.0 software and the compliance services and training offered by Agilent Technologies.
The document outlines how the Agilent LC/MSD Trap Security Pack 1.0 Software meets the requirements of FDA regulation 21 CFR Part 11 regarding electronic records and signatures in pharmaceutical systems. It covers features such as system validation, audit trails, and data integrity.
Key compliance capabilities include user management with password protection, customizable timeout settings, and secure storage of electronic records to prevent overwriting. The software also provides comprehensive audit trails for all system events and user actions.
The software is designed for closed systems that typify pharmaceutical firms, where there is physical access control to the site and a firewall in place for network applications.
The software prevents even system administrators from knowing other users' passwords; while admins assign initial passwords, users must change them at first logon.
Data versioning maintains multiple copies of processed results in a result history, and the capability to delete results is controlled as a separate user privilege.