The Title 21 CFR part 11/annex11 compatible software package for the 4D-Nucleofector™ System.

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In addition to the standard software which is automatically implemented on each 4D-Nucleofector™ System, Lonza offers the 4D-Nucleofector™ LogWare suited for use in regulatory environments.

 

 

 

For compliance with Title 21 CFR part 11/annex 11, the 4D-Nucleofector™ LogWare comprises specific features that ensure data consistency, enable electronic signatures and create electronic records of the system usage.

 

Benefit from:

 

  • User administration rights to create and manage users and allow data export according to Title 21 CFR part 11
  • Generation of audit trails
  • User login and re-authentication before conducting an experiment
  • Logging of every data creation or modification (e.g. creating an experiment) as a specific user activity together with user information and a time stamp
  • Logging of experiments with an enhanced result data set containing serial numbers, time stamps and user information
  • Reporting of results: failure type and detailed failure description
  • Printing of results including user information, time stamp and specific well  information (parameters, results, additional information)
  • Generation of encrypted data and reports which are safely stored on the device (deletion is not possible)

 

 

 

4D-Nucleofector™ LogWare Version: Click here to view the most recent status of the software.

 

Ordering Information

Please contact Customer Service for pricing information.

SAAF-1001      4D-Nucleofector™ LogWare