This GxP Software Kit allows LabChip GX and GXII Touch instruments to operate in an environment consistent with 21 CFR Part 11 compliance and validation.
For research use only. Not for use in diagnostic procedures.
The GxP Software Kit contains built-in technical controls and features specifically designed to provide compatibility with 21 CFR Part 11 requirements. The LabChip GxP kit ensures that assays, output data, analysis settings, event data, and backup data files are not available for editing or tampering. Data is stored in a secure folder on either the LabChip GX Touch computer, the LabChip Reviewer computer, or a network server. The LabChip GxP kit utilizes two main components, the Central Data Repository (CDR) and the CFR database. The CDR is a secure folder that contains assay files and data files. The CFR database is a secure database that contains the LabChip GX Touch user accounts, Audit Trail, and data folder information. To create and maintain the CFR database, Microsoft® SQL Server® Express is provided with the LabChip GxP kit.
Brand |
LabChip GX
LabChip GXII
|
---|---|
Unit Size |
1 Unit
|
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