For Pharmaceutical Industries

Achieving both data integrity compliance and excellent operability.

Compliant with FDA 21 CFR Part 11, Annex 11, and PIC/S PI 041, the system ensures data integrity while offering improved operational efficiency and superior usability.

User Authentication (User Management)

Administrators can set operational permissions for each access level and assign appropriate access rights to individual users. This prevents unauthorized operations and enables monitoring for operator error. By adding the optional Active Directory integration (LDAP/LDAPS), user information can be centrally managed within your company’s system. Each operator can log in to multiple machines on the production line using a single user account.

*Active Directory is a trademark of the Microsoft group of companies.

Audit Trail

The system records operation history, production‑related actions, and the results of operational checks. These records can be used to monitor unauthorized or incorrect operations and to analyze their causes. When parameters are changed, the reason for change can be entered and stored in the output data.

Data Output

Audit trail records and statistical data can be output through Ethernet as non‑editable PDF reports or encrypted data files.　Encrypted files can also be exported to a USB memory device and decrypted on a PC.

Data Backup & Restore Over Ethernet

In the event of memory failure or other issues, various data and device parameter settings can be safely backed up and restored over Ethernet, ensuring data integrity and system reliability.