ProteoAnalyzer Software Security Module
Built for Compliant, Secure, and Traceable Protein Analysis Workflows
- The ProteoAnalyzer 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 provides system access controls, ensures traceability through audit trails, and streamlines approval workflows with integrated eSignature functionality.
- The ProteoAnalyzer software security module operates autonomously as a standalone package, consisting of the Administration Software for system configuration and access control, ProteoAnalyzer controller for instrument communication and data acquisition, and ProSize data analysis software for high-resolution data processing and interpretation.
- Account Management - Allows administrators to specify which users can access the system. Only those who have been added by administrators can interact with the electronic records.
- Access Management - Customizable roles to determine a user’s access level. These roles can be grouped together for permission access link to projects.
- Audit Trails - The software keeps 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.
- Data Approval and Approval Workflows - eSignature is available for data review approval workflow. Customizable workflows can be used to enforce a specific order of signatures and their meanings.
- Reporting - Allow users to generate reports to be exported as CSV and PDF file for specific audience and purposes.
- IQ/OQ Services - Complete IQ/OQ service is available to ensure the system hardware and software operates per manufacturer’s specifications
Overview
Specifications
How it works
Built Compliance into your ProteoAnalyzer Workflow
The ProteoAnalyzer software security module is designed to support regulated laboratory workflows by integrating compliance‑supporting functionality into routine ProteoAnalyzer use. Embedded directly within the ProteoAnalyzer software, it provides role‑based user access, secure data acquisition, review, and approval processes, comprehensive audit trails, and electronic signatures to help maintain data integrity and traceability in regulated environments.
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