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Pharma & Biotech

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 under development.

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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.

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.**

Content & Storage

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

Instructions

Safety Data Sheets (SDS)

Certificate of Analysis (CoA)

Please enter Lot Number, including all zeros, located on the product label and please take into account that it is case sensitive.

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