Attune NxT Software 21 CFR Part 11 is for use with the Attune NxT Acoustic Focusing Cytometer and supports compliance with 21 CFR Part 11 FDA guidelines for security, auditing, and electronic (SAE) signatures using an SAE console. The software helps prevent unauthorized access to the system and is available for use on computers with the Windows 10 operating system.
Features of the Attune NxT Software 21 CFR Part 11 include:
• Authentication of user log-in 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
• Identification of data tampering
• Generation of audit trail log
• Ability of administrator to determine functions required to input reason for change
• Tracking of changes to user roles, account management, and system settings
• Assignment of unique identifiers for experiments and objects within experiments to identify any changes from original record
• Audit trail record presented in human-readable format
• Administrator determination of e-signature requirements
• Ability to review records and sign electronically
Along with the 21 CFR part 11 software license, our service and support organization offers these services to help you validate you instrument, software, and computer: IQOQ and computer software validation services.