Thermo Fisher, A51025, Countess™ 3 21 CFR Part 11 Software Module

Countess™ 3 21 CFR Part 11 Software Module The Countess 3 21 CFR Part 11 Software Module is for use with the Countess 3 and Countess 3 FL automated cell counters and supports compliance with 21 CFR Part 11 FDA guidelines for security, auditing, and electronic (SAE) signatures using an SAE administration console.
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. Both procedural and technical requirements must be met to achieve 21 CFR Part 11 compliance for traceability of electronic records.
To implement the Countess 3 21 CFR Part 11 Software Module for 21 CFR Part 11 support on the Countess 3 and Countess 3 FL automated cell counters, the following components are required to be installed, activated, and communicating:SAE Administrator Console—installed on a local server and allows configuration of the SAE settings for Countess 3 automated cell counters with the Countess 3 application profileCountess 3 21 CFR part 11 license key—used to activate the SAE settings for the Countess 3 automated cell counterCountess 3 instrument, with SAE mode enabled—connected to the SAE Administrator ConsoleFeatures of the Countess 3 21 CFR Part 11 Software Module include: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 functions required to input reason for commitAudit trail record presented in readable and filterable formatsElectronic signatureAdministrator determination of e-signature requirementsAbility to review records and sign electronicallyAlong with the 21 CFR Part 11 software, our service and support organization offers IQ/OQ qualification services for your instrument and support training.
For Use With (Equipment): Countess 3 & Countess 3 FL
Includes: 21 CFR, part 11 activation key
Quantity: 1 license
Unit Size: Each