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Pharma & Biotech
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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
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