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Apex-Guard™

Lab Productivity Suite

Apex-Guard software integrates enhanced controls, security, and audit features with Apex-Gamma™ software to advance gamma spectroscopy for your regulated count room.

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Data Sheet

Tag Features

  • Enhanced data integrity and security features integrated into lab productivity suite
  • Features and controls necessary for compliance to US FDA Title 21 CFR Part 11 Electronic Records and Electronic Signatures for pharmaceutical customers
  • Role-based security for user log-ons using MS Windows Policy settings for password and renewal
  • Automatic timed log-off feature
  • Enhanced security for analysis and processing files
  • Enhanced security on detector and MCA configuration
  • Dramatically improved audit capability with comprehensive audit log
  • Enhanced data review features to view and restore analysis records
  • Electronic Signatures
  • Electronic software licensing with flexible terms and activation methods
  • Comprehensive Service Bundle

Description

The Apex-Guard application builds on Apex-Gamma software to provide extra security, audit log, and data integrity to meet specific needs for the radiopharmaceutical field. These features are also of interest to many of our non-pharmaceutical customers.

The following features are implemented in Apex-Guard application, above and beyond the current functionality of Apex-Gamma software:

  • Role-based security with Windows Credentials Authentication: User profiles are linked to the Windows domain user which allows Windows Policy settings to manage the password complexity and renewal frequency.
  • Automatic timed log-off feature: Administrator user setting defines an inactivity time limit and logs the user off the system when the limit is exceeded.
  • Enhanced security for analysis and data processing files: Editing permissions on essential files for analysis and data are allowed only within the application. This includes calibration, nuclide library, ISOCS™ and LabSOCS™ associated files (for efficiency calibration and cascade summing correction), QA, and scripts.
  • Enhanced security on detector and MCA controls: Modification of detector settings configured and active in an Apex-Guard system is not possible outside the Apex-Gamma application, including from Genie™ Acquisition and Analysis software.

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