Beckman Coulter Avanti JXN/Optima XPN Centrifuge 21 CFR Part 11 Compliance Statement

About this manual

Beckman Coulter's new generation of intelligent centrifuges, specifically the Avanti JXN high-speed and Optima XPN ultracentrifuge series, provides solutions to meet the requirements of the US Federal Regulations Chapter 21 Part 11. These regulations ensure the accuracy, reliability, authenticity, and consistency of electronic records in laboratory environments.

The document explains how these centrifuges achieve compliance through features such as user account management, closed system administration, audit trails with timestamps, and secure electronic signatures. Key capabilities include password-protected access for up to 50 users, automatic logout after periods of inactivity, and the ability to export logs and records in PDF, XML, and CSV formats. This manual is written in Chinese.

What's inside

• Introduction
• Electronic Records (21 CFR Sec. 11.10)
• Closed System Management
• Audit Trails
• Electronic Signatures (21 CFR Sec. 11.100)
• User Authentication and Roles

Specifications

Frequently asked questions

Do the Avanti JXN and Optima XPN centrifuges support 21 CFR Part 11 compliance?

Yes, both software series provide solutions to meet the requirements of US Federal Regulations Chapter 21 Part 11.

How many users can access the software simultaneously?

The software supports up to 50 independent users with password protection.

Can electronic records be exported for external storage?

Yes, logs and system option logs can be exported to USB devices or network storage in PDF, XML, and CSV formats.