Bio-Rad Experion DNA Analysis Kits - Manual

Introduction
Experion Security Edition software provides a secure environment for the maintenance, verification,
and tracking of all electronic records generated by Experion software. Security Edition software
offers tools for compliance with US FDA 21 CFR Part 11 regulations. Features include:
• Authorization system to provide secure user login and allow different levels of access for
authorized users.
• Audit trail table to track daily use of the system
• Password protection and auto lock function to maintain database and file integrity
• Electronic signatures for easy record keeping and tracking
• Report generation for quick viewing and archiving of multiple run parameters, data, audit
trail, and electronic signatures
The installation qualification and operational qualification (IQ/OQ) validation kit is included with the
Security Edition package. The IQ/OQ protocols test the critical functions of the system to verify
and validate the system to the specified functionality. Installation qualification should be performed
when the system is moved to a new location, when the software is upgraded, and when the
computer that runs the electrophoresis station is changed or modified. Operational qualification
should be run on a regular basis.
• Ensure reliability and consistency of analysis results
• Allow automation with incorporated procedures in Experion software (version 2.0+)
• Perform routine instrument maintenance and validation procedures
User Access
When security mode is enabled, only an authorized and authenticated user (created within
Experion software) can access the software. Each user is associated with one of five different
access levels.
Each access level can be configured to allow or deny access to different features and functions of
Experion software.
Experion ™ Security Edition Software Setup Guide
(Catalog Number 700-7052)
Bio-Rad Laboratories, Inc., 2000 Alfred Nobel Drive, Hercules, CA 94547 USA • (510) 741-1000
10005581 Rev C