Fragment Analyzer Software Security Module
The Agilent Fragment Analyzer software security module is designed for laboratories that must comply with the guidelines of FDA 21 CFR Part 11, EU Annex 11, GxP, and similar national electronic record regulations. This software module supports system access control, traceability for data analysis visible in audit trails, and approval workflow with eSignature functionality.
The Fragment Analyzer software security module operates autonomously as a standalone package, consisting of the Administration Software, Fragment Analyzer controller, and ProSize data analysis software.
The Fragment Analyzer software security module operates autonomously as a standalone package, consisting of the Administration Software, Fragment Analyzer controller, and ProSize data analysis software.
- Fragment Analyzer Systems Software
Product Details
Features
- Account management – Allow administrators to specify users with the access to the system. Only those who have been added by administrators can interact with the electronic records.
- Access management – Customizable roles to determine a users access level. These roles can be grouped together for permission access link to projects.
- Detailed audit trails – Keep a detailed record of actions taken on a measurement in a file-specific audit trail. System changes are also tracked in a system activity log.
- Efficient data approval and approval workflows – Enforce a specific order of signatures and their meanings with customizable workflows. eSignature is available for data review approval workflow.
- Reporting – Allow users to generate reports to be exported as CSV and PDF file for specific audience and purposes.
- Complete IQ/OQ Services – Ensure the system hardware and software operate per manufacturers specifications.
Specifications
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Literature
- Data Sheets
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Agilent Fragment Analyzer Security Module, Fragment analyzer controller rev. 5.0.0, ProSize data analysis software rev 6.0.0
The Fragment Analyzer security module software package supports using the Agilent Fragment Analyzer systems in regulated laboratory environments.
- Data Sheets
- English
- 05 Feb 2025
- 188.13 KB
Agilent ProSize Data Analysis Software For the Agilent Fragment Analyzer, Femto Pulse and ZAG DNA Analyzer Parallel Electrophoresis Systems
This data sheet describes the features, benefits and specifications of the Agilent ProSize software for Agilent Fragment Analyzer, Femto Pulse and ZAG DNA Analyzer
- Data Sheets
- English
- 05 Feb 2025
- 364.45 KB
- Specifications
- White Papers
Support
- User Manuals
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Agilent Security Module Software user manual
This document includes the introduction, installation, initial tasks, reocurring tasks, and other administrative elements of the Fragment Analyzer Security Module Software.
- User Manuals
- English
- 04 Jul 2025
- 1.01 MB
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