LabChip GX/GXII User Manual

Software Security 90Software SecurityA 21 CFR Part 11 Compliance option is available for the LabChipGX software. This option ensures that assays, output data, analysissettings, event data, and backup data files are not available forediting or tampering. Data is stored in a secure folder on the localcomputer. To create and maintain the Audit Log and LabChip GXuser accounts, Microsoft SQL Server 2005 Express is provided withthe LabChip 21 CFR Part 11 option.The following procedures are included in this section:“Locking and Unlocking the Software” on page 92“Managing User Accounts” on page 93• “Adding New Users” on page 94• “Changing User Information” on page 95• “Printing User Information” on page 96• “Activating and Deactivating User Accounts” on page 96• “Changing Access Rights” on page 97• “Printing Access Rights” on page 98• “Setting Policies for User Accounts” on page 99• “Printing User Policies” on page 100“Electronic Signatures” on page 101“Automatically Exporting Copies of Data Files” on page 102“Reverting to a Specific Data File Revision” on page 102“Audit Trail” on page 103• “Viewing the Audit Trail” on page 104• “Exporting the Audit Trail” on page 105“Central Data Repository (CDR)” on page 106• “CDR Security Suggestions” on page 106• “Creating New Data Folders” on page 107• “Moving Data Files into Folders” on page 107• “Deleting Data Folders” on page 107• “Hiding Data Files in the CDR Manager Window” on page 108• “Showing Hidden Data Files in the CDR Manager Window” onpage 108“Remote CDR Server Backup” on page 109• “Setting Up the Remote CDR Server” on page 109P/N 127170 Rev. 00 LabChip GX User Manual Caliper Life Sciences, Inc.