Lucullus is fully compliant with 21 CFR Part 11, including features such as digital signing for process changes, automatic generation of an audit trail, and ensuring full data integrity.
- ACCESS SECURITY:
The Access Security includes features such as the use of a unique combination of user ID and password, customizable password security settings, comprehensive logging of access security actions in an audit trail, and extensive user management capabilities for roles and groups.
- ELECTRONIC SIGNATURE
Lucullus® enforces the authorization of defined interactions by a user with the appropriate authorization. Confirmation of changes is requested with pop-up windows. The following information is stored in the audit trail: reason, timestamp, and printed username.
- AUDIT TRAIL
Lucullus® provides a continuous audit trail that is protected against deactivation and tampering. It tracks the user interactions and all events during a process. A second audit trail on the database level logs all changes in system configuration.
The Lucullus® interface is designed to prevent process deletion and raw data modification to ensure data integrity. A robust data integrity checking mechanism prevents the deletion of resources associated with active processes and serves as an additional layer of protection to ensure data consistency and reliability.
Read more about using the Lucullus REST API interface in the following articles:
- LUCULLUS® AS CENTRAL PROCESS CONTROL SOFTWARE IN GMP PRODUCTION OF MONOCLONAL ANTIBODIES
- LUCULLUS®: VALIDATED DATA HISTORIAN FOR MRNA VACCINE PRODUCTION PROCESSES