Description of Audit Trail Software option

• The REA Audit Trail software is an optional software extension for REA VeriCube.
  Audit trails are required for applications in the healthcare industry (pharmaceutical products and medical devices). In the healthcare industry, work must be performed under strictly controlled conditions (GxP-compliant) both in production and in laboratory areas. This is monitored by regulatory authorities through audits. The background for this is the U.S. law 21 CFR Part 11 as well as GMP/GAMP requirements from the European Union and the United States.
  
  All actions relevant to measurement results are monitored and documented in an audit trail, accessible for reviews. This allows for tracking who has performed, saved, and printed measurements with appropriate settings. Additionally, other actions and configuration changes in the system can be traced.
  
  Acquired data must be protected against manipulation. For this reason, all relevant data and configurations are stored and retrieved using a system called "Data Server." Only the Data Server has access to the "repository" where user data, measurement data, and audit trail log data are stored.
  
  Features:
  - Data repository protected against unauthorized access
  - Configurable automatic backup of all data
  - Full audit trail view, logging every event including system events such as automatic log off. The audit trail view can be filtered (actions, users, dates, etc.)
  - Archiving of data including closing of ongoing audit trails
  - Automatic application closure upon user logoff and Windows screensaver activation
  - IQ/OQ form templates are freely available
  
  - Protection against data manipulation:
  - Printing is only possible for saved reports
  - Export and import of data are blocked.
• Local User Management
  - User management with 4 user roles
  - User password history (12)
  - Password validity: 90 days
  - Password security - minimum 8 characters: uppercase letters, lowercase letters, numbers, and special characters (3 out of 4 categories are mandatory)
  
  User Management with Active Directory
  - User management with 3 roles
  - Password strength and management are handled completely through the Active Directory system
  
  System Requirements
  - Windows 10, 64-bit
  - Memory ≥ 8 GB
  - ≥ 1 TB HDD for storage, a local SSD hard drive is recommended
  - Processor Intel i5 / AMD Ryzen or better
  - Separate 1 Gb/s Ethernet port for REA VeriCube