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  6. Invitrogen™ Attune™ NxT Software 21 CFR Part 11

Invitrogen™ Attune™ NxT Software 21 CFR Part 11

Catalog No. p-7183423
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1 License
1 Server license, 10 users
1 Server license, 5 users
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Catalog No. Quantity
A47288 1 License
A47289 1 Server license, 5 users
A47290 1 Server license, 10 users
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Catalog No. A47288 Supplier Invitrogen™ Supplier No. A47288

Please call Customer Service at 1-800-234-7437 or send an email to help@thermofisher.com for assistance.

Description

Attune NxT Software 21 CFR Part 11 is for use with the Attune NxT Acoustic Focusing Cytometer and supports compliance with 21 CFR Part 11 FDA guidelines for security, auditing, and electronic (SAE) signatures using an SAE console.

  • The software helps prevent unauthorized access to the system and is available for use on computers with the Windows 10 operating system.
  • Authentication of user log-in 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
  • Identification of data tampering
  • Generation of audit trail log
  • Ability of administrator to determine functions required to input reason for change
  • Tracking of changes to user roles, account management, and system settings
  • Assignment of unique identifiers for experiments and objects within experiments to identify any changes from original record
  • Audit trail record presented in human-readable format
  • Administrator determination of e-signature requirements
  • Ability to review records and sign electronically
  • Along with the 21 CFR part 11 software license, our service and support organization offers these services to help you validate you instrument, software, and computer: IQOQ and computer software validation services.

Specifications

Product Line Attune
Product Type Flow Cytometer Software
Shipping Condition Room Temperature
For Use With (Equipment) Attune™ NxT Acoustic Focusing Cytometer
Quantity 1 License

For Research Use Only. Not for use in diagnostic procedures.