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Invitrogen™ iBright™ SAE Software for 21 CFR Part 11, single license
For use with the iBright Imaging System and supports compliance with 21 CFR Part 11 FDA guidelines for security, auditing, and electronic (SAE) signatures using the SAE console.
Supplier: Invitrogen™ A49208
Description
- 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
- Generation of audit trail log
- Tracking of changes and committed actions to user roles, account management, and system settings
- Ability of administrator to determine functions required to input reason for commit
- Administrator determination of e-signature requirements
- Ability to review records and sign electronically
Spécifications
| iBright Imaging System | |
| Software License | |
| Software License |
| iBright | |
| 1 license |