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  5. A49208

Invitrogen™ iBright™ SAE Software for 21 CFR Part 11, single license

Catalog No. A49208
Encompass_Preferred
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Quantity:
1 license

Description

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.

  • 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
TRUSTED_SUSTAINABILITY

Specifications

For Use With (Equipment) iBright Imaging System
Product Line iBright
Type Software License
Quantity 1 license
Software Type Software License

Safety and Handling

WARNING: Reproductive Harm - www.P65Warnings.ca.gov
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