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YSI 2900 - CFR Part 11

YSI 2900
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7.1.5.1 Standby
Enable the Standby function by touching the [OFF] button next to “Standby” and changing it to [ON].
Touch the number of Minutes button [60] next to “Start after.” Enter the number of minutes that the instrument should
remain idle before enabling the screensaver, then touch [OK].
If 21 CFR Part 11 Mode is enabled, the screensaver locks the screen and a User name and Pin are required to unlock the
screen (see 7.1.6 21 CFR Part 11).
The maximum setting for number of minutes with 21 CFR Part 11 Mode enabled is 60.
After you have finished making your changes, touch the [X] button to return to the main display.
7.1.6 21 CFR Part 11
FDA 21 CFR Part 11, Electronic Records; Electronic Signatures, was established by the FDA to define the requirements
for submitting documentation in electronic form and the criteria for approved electronic signatures. Since YSI 2900 Series
analyzers generate electronic records, these systems must facilitate compliance with 21 CFR Part 11.
YSI 2900 Series analyzers feature the following functions to provide 21 CFR 11 compliance:
Audit & event trails
Secure user sign-on
User level permissions
Administrative configuration tools
From the Settings screen, touch the [21 CFR Part 11] tab.
To enable 21 CFR Part 11 mode, touch the [Enable 21 CFR Part 11 Mode] button.

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