Data integrity in focus: The Rotronic Monitoring System (RMS) and ALCOA+ principles

ALCOA Infographic

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The preservation of data integrity is of central importance for compliance with regulatory requirements and the optimization of production processes. The ALCOA principles, originally introduced by the U.S. Food and Drug Administration (FDA), specify that records must be attributable, legible, contemporaneous, original, and accurate. With the introduction of ALCOA+, these principles have been expanded to include completeness, consistency, durability, and availability, and they are now applied internationally.

The application of these principles, especially in the context of FDA 21 CFR Part 11, forms the basis of the Rotronic Monitoring System (RMS). This report highlights how the RMS integrates these principles into its methodology and compliance.

ALCOA

Attributable: The RMS ensures attribution by assigning unique labels to each element created by the user. The audit trail uses data loggers to document product changes and other modifications. Individual, password-protected accounts and role-based user rights enable precise traceability.

Legible: By implementing password-protected user accounts and defined signatures, the RMS ensures that events are readable and traceable for authorized users. The audit trail records actions and comments related to changes in process conditions.

Contemporaneous: The RMS software application uses SNTP functionality for continuous synchronization of devices. Whether the RMS hardware is wired or wireless, it records events in real time and allows users to adjust process parameters.

Original: Once RMS devices are set up, they are protected against data manipulation. All data are securely stored on a server. RMS automatically detects and reports changes to raw data. PDF documents, such as calibration reports, can be verified for authenticity via the platform.

Accurate: Rotronic offers highly precise measuring devices calibrated according to ISO17025 standards. Digital communication within the RMS system prevents data loss, and modifications to the measuring devices are recorded in the audit trail.

ALCOA+

Complete: RMS automatically generates comprehensive logs that can be easily accessed by authorized users. This includes changes to device configurations, alarms, user actions, calibrations, and errors. The online manual provides an overview of all RMS audit trail events.

Consistent: All timestamps are recorded in UTC time, ensuring consistent and secure documentation. Time synchronization is achieved via the Network Time Protocol (NTP). Detailed monitoring of server time is possible through a system measurement point.

Durable: The RMS is designed for longevity and can be configured in local or cloud environments, with ISO27001 certification ensuring data integrity and availability. Data can be easily exported to data historians via OPC connectivity.

Available: The RMS offers customizable dashboards and controlled access to data sets. This ensures security and traceability for authorized users.

The Rotronic Monitoring System ensures that the principles of ALCOA & ALCOA+ are maintained for both paper-based and electronic records, providing a comprehensive solution for data integrity and availability requirements in regulated environments.