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Invitrogen™ Qubit™ Flex Security Software
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Quantity:
1 license
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Each
Descripción
- 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
Especificaciones
Especificaciones
| Type | Software |
| Quantity | 1 license |
| For Use With (Equipment) | Qubit Flex Fluorometer |
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