Using the Alliance iS HPLC system in a regulated environment

The Empower Authentication feature in Alliance iS ensures secure user authentication and traceable audit logging, supporting alignment with ALCOA++ data integrity principles.

The Empower Authentication feature enhances the Alliance iS HPLC system's suitability for use in regulated environments by ensuring that all auditable actions and events are securely attributed to the authenticated Empower user. While the system continuously generates system logs to record auditable actions and events, enabling the Empower Authentication feature ensures that each action or event is linked to a specific user and captured in the Alliance iS HPLC system log and also in the Empower System Audit Trail (if the system audit trail option is enabled), using secure, time- and date-stamped audit trail records. See Audit trail information in Empower and Alliance iS HPLC system audit trail.

This supports alignment with industry-wide data integrity standards, commonly referred to as ALCOA++. These principles guide how data is recorded and maintained in regulated environments:

• Attributable: Each action is linked to a specific user via their Empower ID.
• Legible: Recorded data must be clear and readable for audits and reviews.
• Contemporaneous: Events are logged at the time they occur, not retroactively.
• Original: The system preserves the initial record of each action.
• Accurate: Logged data reflects the true nature of the event or action.
• Complete: All relevant data, including changes, is captured.
• Consistent: Events are recorded in a uniform and logical sequence.
• Enduring: Records are stored in a secure, lasting format.
• Available: Data remains accessible for inspection or reporting.
• Traceable: Each record includes a clear audit trail back to its source.

By aligning with ALCOA++ standards, the Empower Authentication feature helps users meet regulatory compliance requirements set by agencies such as the FDA and EMA, which mandate reliable, auditable, and secure data practices.