Enhanced Data Security

Securing your data and satisfying auditors

The Enhanced Data Security (EDS) module is a software option that provides enhanced trust in results for users of the Zetium XRF spectrometer (through the SuperQ software) and the Epsilon XRF spectrometer. With capabilities including advanced user management, action logging, data protection, and application status assignment, EDS helps you strengthen your audit trail, minimize the risk of error, and prove that your XRF instrument is working as expected.

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Features

Please note: The full range of features for EDS described below are only available with SuperQ version 6.4 and upwards. Please refer to the EDS software brochure for details.

Administrator-level user setup

To ensure that user setup is tightly controlled, within EDS the assignment of usernames and passwords is delegated to the operating system, meaning that they can only be changed by the company’s IT administrators.

Application status settings

To eliminate the risk of accidental use of an application still in development, applications can be versioned, and given one of three status levels: ‘Developing’, ‘In review’ or ‘Finished’. These status levels can only be changed if approved by two people (‘four-eyes signing’).

In addition, user privileges mean that only defined users can access applications with a particular status, or change the status of an application.

Requirement for electronic signatures

EDS provides enhanced security for certain important actions relating to measurements and results, by requiring an electronic ‘signature’ (comprising a password and a reason for the action).

Enhanced action logging

For those situations requiring a watertight audit trail, EDS extends the basic action logging offered as standard within the instrument software. Options include logs of actions relating to application status, logs of actions leading to modified results, as well as the requirement to add a comment against all actions.

Robust data storage

To eliminate the risk of accidental loss of data, when an action leads to modified application or calibration results, EDS prevents new files from overwriting the originals (which are retained as read-only files). This feature complements the data-protection features that can be set up by the system administrator (disallowing editing of records outside the program, and user privileges for protection of data files and log files).

Customizable data security

All the above-mentioned software options are configurable, so that for customers in non-regulated environments, only part of the functionality can be implemented, if desired. 

Specification

Designed for compliance with FDA 21 CFR Part 11

Designed for GMP and GLP environments, Enhanced Data Security (EDS) supports PANalytical XRF system owners to comply with strict laboratory regulations.