Invitrogen™ Attune™ NxT Software 21 CFR Part 11

Description

• The software helps prevent unauthorized access to the system and is available for use on computers with the Windows 10 operating system.
• 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.