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4D-Nucleofector® LogWare

4D-Nucleofector® LogWare

Catalog #: SAAF-1001

The 21 CFR part 11 compliant software for first generation 4D-Nucleofector® Systems running under software version 4.**.

 

Note: For next generation 4D-Nucleofector®Systems running under software version 5.**, the corresponding LogWare is available (cat. no.: SAAF-1002, product page under development).

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 14’480.00 CHF
ST

Product Overview

For the 4D-Nucleofector® System, Lonza offers accessory products which provide higher quality standards for transfection applications in upstream GMP manufacturing environments.

The 4D-Nucleofector® LogWare is a 21CFR part 11 compliant software version of the standard software that supports the use of the 4D-Nucleofector® System in a GMP environment.  A validation documentation is available on request.

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Benefits

  • Compliance with Title 21 CFR part 11/annex 11
  • User administration
  • Electronic signatures with user name and password
  • Logging of any modification, creation of data or user interaction with time stamp
  • Reporting of result failures with failure description
  • Data export according to Title 21 CFR part 11
  • Generation of audit trails
  • No data deletion possible

Applications

  • For use of the 4D-Nucleofector® System in a GMP process
  • Compatible with first generation 4D-Nucleofector® Systems running under software version 4.**

Storage and Content

1 x USB stick with 4D-Nucleofector® LogWare
1 x USB stick with 4D-Nucleofector® LogWare Off
1 x USB hub
1 x Keyboard

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