CFR 21 regulation
The regulation applies to all FDA-regulated industries, including pharmaceuticals, biotechnology, and medical devices. It is part of the broader Code of Federal Regulations and focuses on making sure that digital information is complete, accurate, and protected from unauthorized changes.
Lucullus® is designed to fulfill the requirements for electronic records and electronic signatures for GMP applications. It is compliant with the FDA 21 CFR Part 11 guideline.
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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. |
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Electronic Signature |
Lucullus® enforces the authorization of defined interactions by authorized users. Confirmation of changes is requested via pop-up windows. The following information is stored in the audit trail: reason, timestamp, and printed username. |
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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 at the database level logs all changes made in system configuration. |
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Archiving and Retrieval |
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. |