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Invitrogen™ Qubit™ Flex Security Software
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).
Brand: Invitrogen™ Q31994
805.14 EUR valid until 2024-12-31
Use promo code "21658" to get your promotional price.
This item is not returnable.
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Description
- 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
Specifications
| Software | |
| 1 license | |
| Qubit Flex Fluorometer |