Apex-Guard™

Lab Productivity Suite
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Apex-Guard™

Lab Productivity Suite
Favorite this Product

Apex-Guard Lab Productivity Software integrates enhanced controls, security, and audit features with Apex-Gamma™ software for improved quality assurance and regulatory compliance.

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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
  • Comprehensive audit log
    • Parameter modified
    • User who made the modification
    • Date/Time change was made
    • Value prior to modification
    • Value after modification
    • Justification or comment for modification
  • Enhanced data review features to view and restore analysis records
  • Electronic Signatures
  • Electronic software licensing with flexible terms (1 year or perpetual), and activation methods (direct online and remote offline)
  • Available Comprehensive Service Bundle including Apex-Guard software (3-year term), IQ/OQ Installation and customization, virtual training classes, and technical support credit

Description

Apex-Guard application builds on Apex-Gamma software to provide extra security, audit log, and data integrity to meet specific needs of our pharmaceutical customers. 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.

Resources

Product Manuals and Guides
Genie and Apex Qualification Matrix

Support

800 Research Parkway
Meriden CT, 06450


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