LabChip GxP Option 62
P/N CLS151164 Rev. B LabChip GX Touch/GXII Touch User Manual PerkinElmer, Inc.
LabChip GxP Option
A LabChip GxP option is available for the LabChip GX Touch
software. This option contains built-in technical controls and
features specifically designed to provide compatibility with 21 CFR
Part 11 requirements. Users are responsible for establishing
policies and standard operating procedures that complement the
capabilities provided by the software in order to ensure complete
compliance to the rule.
NOTE
Using the LabChip GxP compatibility option alone does not ensure
21 CFR Part 11 compliance. Laboratory processes and procedures
must comply with 21 CFR Part 11 regulations.
The LabChip GxP 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 or on a network server. To manage LabChip GX Touch
user accounts, Microsoft
®
SQL Server
®
2014 Express is provided
with the LabChip GxP option.
The LabChip GxP option requires an internal USB Key (dongle)
installed inside the instrument cover. The USB Key is only to be
installed by trained PerkinElmer Service personnel.
The following procedures are included in this section:
• Locking and Unlocking the Software on page 63
• User Accounts on page 64
— Switching Users on page 64
• Central Data Repository (CDR) on page 65
— CDR Security Suggestions on page 65
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