4D-Nucleofector® LogWare Gen 2
4D-Nucleofector® LogWare Gen 2
The 4D-Nucleofector® LogWare Gen 2 is the 21 CFR part 11 compliant software for next generation 4D-Nucleofector® Systems running under software version ≥ V05.**.
Note: For first generation 4D-Nucleofector® Systems running under software version V03.** or V04.**, the corresponding LogWare is available under catalog number SAAF-1001.
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Product Overview
In addition to the standard software included with every 4D-Nucleofector® System, Lonza offers 4D-Nucleofector® LogWare, designed for use in regulated environments and to support GMP-compliant manufacturing processes.
4D-Nucleofector® LogWare Gen 2 provides dedicated functionality to support compliance with 21 CFR Part 11 requirements. These features help ensure data integrity, enable electronic signatures, and create secure electronic records of system usage.
Key features
- User administration capabilities for creating and managing user accounts, as well as controlling data export in accordance with 21 CFR Part 11 requirements
- Generation of comprehensive audit trails
- Mandatory user login and re-authentication prior to conducting experiments
- Recording of all data creation and modification activities (for example, experiment creation), including user identification and timestamp information
- Enhanced experiment logging with serial numbers, timestamps, and user information
- Comprehensive result reporting, failure reporting, and detailed failure descriptions
- Generation of encrypted data files and reports that are securely stored on the instrument and cannot be deleted
System compatibility
4D-Nucleofector® LogWare Gen 2 is compatible with next-generation 4D-Nucleofector® Systems controlled by the Gen 2 Core Unit (Cat. No. AAF-1003B) and running software version V05.** or higher.
The software is compatible with all functional units. However, it is particularly relevant for large-volume applications using the 4D-Nucleofector® LV Unit or LV Unit PRO.
Please note that the software license is linked to the serial number of a specific Core Unit and can only be used with that unit.
Note: For systems controlled by a Gen 1 Core Unit (Cat. No. AAF-1002B) with software version V03.** or V04.** a separate LogWare version is available.
Request More InfoBenefits
- Compliance with Title 21 CFR part 11
- User administration with 2 user levels
- Electronic log of any user interaction (e.g. modification, creation of data) with user name time stamp
- Reporting of result failures with failure description
- Data handling according to Title 21 CFR part 11
- Data encryption
- Data corruption detection
- Generation of exportable audit trails (use and change history)
- No data deletion possible
Applications
For use of the Gen 2 4D-Nucleofector® System, especially the larger volume units LV Unit or LV Unit PRO, in a GMP manufacturing process
Storage and Content
- 1 x USB stick with 4D-Nucleofector® LogWare Gen 2, accessory PC software and software manual
- 1 x USB stick with 4D-Nucleofector® LogWare Gen 2 Administrator Reset
- 1 x flexible silicone QWERTY keyboard
- Software manual (hard copy)
SDS, CoA, and Instructions
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.
