Countess™ 3 21 CFR Part 11 Software Module

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

21 CFR Part 11 compliance is composed of both procedural and technical requirements. Procedural requirements are the standard operating procedures instituted by the end user, and technical requirements are the functional characteristics of the compliance management software used. Both procedural and technical requirements must be met to achieve 21 CFR Part 11 compliance for traceability of electronic records.

To implement the Countess 3 21 CFR Part 11 Software Module for 21 CFR Part 11 support on the Countess 3 and Countess 3 FL automated cell counters, the following components are required to be installed, activated, and communicating:

• SAE Administrator Console—installed on a local server and allows configuration of the SAE settings for Countess 3 automated cell counters with the Countess 3 application profile
• Countess 3 21 CFR part 11 license key—used to activate the SAE settings for the Countess 3 automated cell counter
• Countess 3 instrument, with SAE mode enabled—connected to the SAE Administrator Console

Features of the Countess 3 21 CFR Part 11 Software Module include:

Security

• Authentication of user login information
• Ability to set password guidelines and expiry dates
• Lockout access and re-authentication requirements after a period of inactivity
• System lockout upon unauthorized attempts to access software
• Ability of administrator to define user roles and permissions
• Verification of each user's permissions to perform predefined activities
• Identification of data tampering

Auditing

• Generation of audit trail log
• Tracking of changes and committed actions to user roles, account management, and system settings
• Ability of administrator to determine functions required to input reason for commit
• Audit trail record presented in readable and filterable formats

Electronic signature

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

Along with the 21 CFR Part 11 software, our service and support organization offers IQ/OQ qualification services for your instrument and support training.