Software Security 114
V4.2 LabChip GX User Manual PerkinElmer
Software Security
A 21 CFR Part 11 Compliance option is available for the LabChip
GX software. This option 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 the local
computer. To create and maintain the Audit Log and LabChip GX
user accounts, Microsoft SQL Server 2005 Express is provided with
the LabChip 21 CFR Part 11 option.
The following procedures are included in this section:
“Locking and Unlocking the Software” on page 116
“Managing User Accounts” on page 117
• “Adding New Users” on page 118
• “Changing User Information” on page 119
• “Printing User Information” on page 120
• “Activating and Deactivating User Accounts” on page 120
• “Changing Access Rights” on page 121
• “Printing Access Rights” on page 122
• “Setting Policies for User Accounts” on page 123
• “Printing User Policies” on page 124
“Electronic Signatures” on page 125
“Automatically Exporting Copies of Data Files” on page 126
“Reverting to a Specific Data File Revision” on page 126
“Audit Trail” on page 127
• “Viewing the Audit Trail” on page 128
• “Exporting the Audit Trail” on page 129
“Central Data Repository (CDR)” on page 130
• “CDR Security Suggestions” on page 130
• “Creating New Data Folders” on page 131
• “Moving Data Files into Folders” on page 131
• “Deleting Data Folders” on page 131
• “Hiding Data Files in the CDR Manager Window” on page 132
• “Showing Hidden Data Files in the CDR Manager Window” on
page 132
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