Thermo Fisher, Q31994, Qubit™ Flex Security Software

Qubit™ Flex Security Software 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).
SecurityAuthentication of user login informationAbility to set password guidelines and expiry datesLockout access and re-authentication requirements after a period of inactivitySystem lockout upon unauthorized attempts to access softwareAbility of administrator to define user roles and permissionsVerification of each user's permissions to perform predefined activitiesIdentification of data tamperingAuditingGeneration of audit trail logTracking of changes and committed actions to user roles, account management, and system settingsAbility of administrator to determine actions that required an input reason to changeAudit trail record presented in readable and filterable formatsElectronic signatureAdministrator determination of e-signature requirementsAbility to review records and sign electronically21 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.
Quantity: 1 license
For Use With (Equipment): Qubit Flex Fluorometer
Type: Software
Unit Size: Each