Thermo Fisher Scientific Countess 3 21 CFR Part 11 Software Module

Invitrogen™ Countess™ 3 21 CFR Part 11 Software Module

The Countess 3 21 CFR Part 11 Software Module is designed for use with the Countess 3 and Countess 3 FL automated cell counters. It supports compliance with FDA 21 CFR Part 11 guidelines for security, auditing, and electronic (SAE) signatures using an SAE administration console.

Overview

21 CFR Part 11 compliance includes both procedural and technical requirements:

• Procedural requirements: Standard operating procedures instituted by the end user.
• Technical requirements: Functional characteristics of the compliance management software.

Both must be met to ensure traceability of electronic records.

Required Components

To implement the Countess 3 21 CFR Part 11 Software Module, the following components must be installed, activated, and communicating:

• SAE Administrator Console: Installed on a local server; allows configuration of SAE settings for Countess 3 instruments.
• Countess 3 21 CFR Part 11 license key: Activates SAE settings for the Countess 3 automated cell counter.
• Countess 3 instrument (SAE mode enabled): Connected to the SAE Administrator Console.

Features

Security

• User authentication and password management
• Password expiry and inactivity lockout settings
• System lockout upon unauthorized access attempts
• Administrator-defined user roles and permissions
• Verification of user permissions for predefined activities
• Detection of data tampering

Auditing

• Generation of audit trail logs
• Tracking of changes and committed actions related to user roles, account management, and system settings
• Administrator-defined functions requiring input of reason for commit
• Audit trail records in readable and filterable formats

Electronic Signature

• Administrator-defined e-signature requirements
• Ability to review records and sign electronically

Additional Support

Thermo Fisher Scientific offers IQ/OQ qualification services and training support for your instrument along with the 21 CFR Part 11 software.

Specifications