Thermo Fisher Scientific Qubit Flex Security Software

Invitrogen™ Qubit™ Flex Security Software

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

Security

• Authentication of user login information
• Password guideline and expiry date settings
• Lockout and re-authentication after inactivity
• System lockout upon unauthorized access attempts
• Administrator-defined user roles and permissions
• Verification of user permissions for predefined activities
• Identification of data tampering

Auditing

• Generation of audit trail logs
• Tracking of changes and committed actions related to user roles, account management, and system settings
• Administrator control over actions requiring input reasons for changes
• Readable and filterable audit trail record formats

Electronic Signature

• Administrator-defined e-signature requirements
• Review and electronic signing of records

21 CFR Part 11 compliance includes both procedural and technical requirements.
Procedural requirements are established by the end user, while technical requirements are provided by compliance management software.
Together, these ensure traceability and integrity of electronic records.

Additionally, Thermo Fisher Scientific offers IQ/OQ services for your instrument alongside the Qubit Flex Security Software.

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