Invitrogen™ Qubit™ Flex Security Software

• Qubit Flex SAE Software for 21 CFR Part 11 support is designed for use with the Qubit Flex Fluorometer
• The software offers features for security, auditing, and electronic signature (SAE)
• 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
• Together, when met, these requirements enable institutions to meet 21 CFR part 11 guidelines for traceability of electronic records

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 actions which required an input reason to change
• Audit trail record presented in readable and filterable formats

Electronic signature

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