The Open RABS sampling system is an open-type laminar flow barrier system that provides a high level of product protection during sample collection in the packaging area.
Control is carried out via a touchscreen panel with multi-level access for users of different categories (operator, service, administrator and auditor).
The software includes a built-in audit trail that ensures complete recording of all user actions, parameter changes, system access, and events relevant to quality control and regulatory compliance.
The audit trail is stored securely, with options to view, filter, and export data to the enterprise server or an external archiving system according to the customer's
internal procedures.
The system supports multi-level access control, user authorization with differentiated rights (operator, service, administrator and auditor), as well as the recording of time, date, and specific actions linked to the user ID.
This guarantees transparency, traceability, and compliance with Good Manufacturing Practice (GMP) requirements and international standards (including 21 CFR Part 11, GAMP 5).