Qubit Flex Security Software for 21 CFR Part 11 support is designed for use with the Qubit Flex Fluorometer. The software offers the following features for security, auditing, and electronic signature (SAE).

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 that 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

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.

Along with the Qubit Flex Security Software for 21 CFR Part 11 support, our service and support organization offers IQ/OQ services for your instrument.