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