Compliance with 21 CFR Part 11 and Eudralex Annex 11: Ensuring Safe Use in Regulated Environments
Compliance with 21 CFR Part 11 and Eudralex Annex 11 is essential for software used in regulated environments. PLA 3.0 meets the requirements of both regulations by providing a comprehensive security infrastructure and user-friendly account management system that ensures the security and integrity of your data.
In accordance with FDA 21 CFR Part 11 and Eudralex Annex 11, PLA 3.0 features a robust security architecture that requires users to log into the system. User accounts and roles are managed through an intuitive interface and are specific to each database. In addition to this account management, PLA 3.0 is equipped with a full range of security options required by both regulatory frameworks. The PLA Administrator can define security policies for each database according to regulatory standards or your company’s specific needs. These features include password complexity, password aging, password blocking, and password history rules. Additionally, inactivity locks can be configured to prevent unauthorized access to the system.
To ensure compliance with 21 CFR Part 11 and Eudralex Annex 11, PLA 3.0 uses the following techniques:
These features ensure data integrity and provide full traceability of all system-relevant actions, as required by both regulations.